WO2014016627A1

WO2014016627A1 - Vitamin and mineral preparations for gravidae for use in trimesters of pregnancy

Info

Publication number: WO2014016627A1
Application number: PCT/HU2013/000030
Authority: WO
Inventors: Ratkó TÜNDE
Original assignee: Baby-Med Professional Company
Priority date: 2012-07-25
Filing date: 2013-03-27
Publication date: 2014-01-30

Abstract

It is theoretically known that the requirement of pregnant and lactating young mothers for vitamins and minerals alters in the various trimesters of pregnancy and during lactation period. The invention relates to a composition family complying the pregnant and lactating young mothers' demands more flexible than ever. Accordingly, the invention relates to compositions corresponding to the division of the time of pregnancy to natural stages, "trimesters", wherein the compositions are suitable for dosing the vitamins, minerals and trace elements to the young mothers in the amounts required for each stages.

Description

VITAMIN AND MINERAL PREPARATIONS FOR GRAVTDAE FOR USE IN

TRIMESTERS OF PREGNANCY

Although it is theoretically well-known that the requirement of pregnant or lactating mothers for vitamins and minerals alters in the various trimesters of pregnancy and during the lactation period, literature particularly addressing this problem is rarely found. Commercialized products for pregnant women typically do not count with the changing requirements, thus the amount of certain vitamins and minerals is not supplemented to the sufficient degree while the concentration of others is elevated to unnecessarily high levels [Baker H. et al. Journal of the American College of Nutrition, Vol. 21, No 1, 33-37 (2002)]. The latter case could lead to the unnecessary overload of the body and result in side effects. In certain cases adiposity or more serious metabolic diseases could develop. It also may not be advantageous if an otherwise healthy foetus becomes overweight, which can make the labour harder.

The inventors' conception is based on the recognition that the intake of nutrition supplementing vitamins and minerals tailored to the demand of the body is especially important during the continuous but well-sectioned period of the pregnancy in the life of women. This also applies to the period before conception when the body prepares or could be prepared for the task to maintain pregnancy and to the lactation period. It is true for both the pregnancy and lactation that the mother's body mainly functions in such a way that the body passes the important vitamins and minerals to the foetus or - through the breast milk - to the baby rather than retaining it. Therefore, the protection of the mother's body is at least as important aspect as the development of the baby. Thus, the health of both the mother and that of the foetus should be taken care of at the same time.

Although the idea of the feasibility of adjusting the vitamin and mineral intake to the periods of pregnancy has already emerged in the state of art (see e.g. US5869084), according to our present knowledge no such product line is available commercially. The reason for this may be the fact that earlier approaches typically rather overloaded the mother's body with vitamins and minerals, which is not advantageous for mothers from several aspects and may also present difficulties regarding formulation.

The earlier compositions while typically ignored the demands of maternal and foetal body, which vary in time, often aimed at "safety" and administered certain vitamins in excess amounts; for example in a systematic study the administration of Materna resulted in unnecessarily high serum levels of folic acid, biotin and riboflavin [Baker H. et al. Journal of the American College of Nutrition, Vol. 21, No 1, 33-37 (2002)].

WO95/35098 (KV Pharmaceutical Corp.) describes products which provide elevated vitamin and mineral intakes for women in the period of pregnancy, lactation and menopause.

The EP0662825B1 (KV Pharmaceutical Corp.) discloses products which provide the allegedly appropriate amount of vitamin and mineral intakes for pregnant mothers in 1-3. trimesters of their pregnancy.

Barger MK. [„Maternal nutrition and perinatal outcomes." J Midwifery Womens Health. (2010) 55(6) 502-1 1.] analyses the effects of dietary and food supplements on the risk of premature birth, on the weight gain of the mother, glucose balance, immune functions and other parameters.

Ramakrishnan U. et al. [,JEffect of prenatal multiple micronutrient supplements on maternal weight and skinfold changes: a randomized double-blind clinical trial in Mexico" Food Nutr Bull. 2005 26(3) 273-80.] also disclose the effects and consequences of vitamins intakes during pregnancy, and compare the effect of supplements containing more micro nutrients („multiple micronutrient supplements", MM) with the case when the gravid takes only iron. Concerning the effect they focused on the weight gain and body composition of the mother during pregnancy and the subsequent period. The authors discovered that micro-nutrient supplement resulted in weight gain detectably in the period after pregnancy.

An important aspect is that supplementing a safe vitamin and mineral supply, possibly all vitamins and/or minerals should be present in the composition kit, is considered increasingly necessary for a pregnant women in the given life period. For a limited time the human body readily survives certain minor deficiencies, and danger rather exists when the deficiency is maintained for a prolonged period. However, specific members of the compound family contain relatively higher doses of compounds especially necessary in the given period (e.g. in certain trimesters). For example, niacine- depleted condition is especially characteristics for pregnant women [Baker H. et al., ibid]. Additionally, in the last period of pregnancy the improved intake of the copper and zinc also have an infection- blocking role and due to their antibacterial effect, they could decrease the risk of early rupture of membranes and therefore the risk of premature birth.

The aim of the present inventors was the creation of a product family which complies with the demands of women with an increased flexibility way than ever. According to the object of the invention, the pregnancy is naturally divided into stages, i.e. "trimesters", and vitamins and minerals are administered to pregnant or lactating mothers in amounts meeting the various demands arising in the various stages. The inventors discovered that the administration of certain members of the vitamin B family is disadvantageous in the last trimester of pregnancy since, for example, it could result in an excessive appetite leading to the overweight of the pregnant or lactating mother (and even the foetus). Besides the psychological and self-evaluation problems, obesity could also cause other risks (e.g. metabolic syndrome) not to mention the fact that during pregnancy the pregnant or lactating mother probably cannot offset this with increased and intensive physical exercises. Provided after labour, the mother proceeds to intensive body weight reduction by dieting, she could experience impaired (e.g. breast milk) alimentation. Thus, the inventors discovered that in the vitamin family for pregnant or lactating mothers it is advantageous to limit the amount of Bl, B2 and B3 in the composition for the third period of pregnancy (third trimester) and/or the amount of vitamin B12 in the second and/or third trimesters.

BRIEF DESCRIPTION OF THE INVENTION

The invention relates to a kit of vitamin and/or mineral compositions for providing physiologically healthy levels of vitamins and/or minerals in pregnant or lactating mothers, said kit comprising at least the following compositions: i) a vitamin and/or mineral composition or a set of compositions consisting of multiple formulation units, for use in the 1st trimester of the pregnancy of a pregnant or lactating mother,

ii) a vitamin and/or mineral composition or a set of compositions consisting of multiple formulation units, for use in the 2nd trimester of the pregnancy of a pregnant or lactating mother,

iii) a vitamin and/or mineral composition or a set of compositions consisting of multiple formulation units, for use in the 3rd trimester of the pregnancy of a pregnant or lactating mother, and optionally

iv) a vitamin and/or mineral composition or a set of compositions consisting of multiple formulation units, for use in the lactation period of a pregnant or lactating mother.

Preferably, a composition suitable for a given period (a trimester or lactation period) comprises at most three, preferably at most two formulation units.

Preferably, specific compositions or sets consisting of formulation units comprise - independently of each other and suitably for the given period - at least the following:

from fat-soluble vitamins:

- Vitamin E,

- Vitamin D,

additionally preferably one ore more of the following:

- Vitamin A,

and/or

from water-soluble vitamins:

- Vitamin B9 (folic acid/folate),

additionally preferably one ore more of the following:

- Vitamin C,

- Vitamin Bl (thiamine),

- Vitamin B2 (riboflavin),

- Vitamin B3 (niacin),

- Vitamin B6 (pyridoxine),

- Vitamin B7 (biotin),

wherein preferably a composition according to iii) does not comprise

- Vitamin Bl (thiamine), or the composition comprises it in an amount not exceeding 0.5 mg or not exceeding 0.2 mg,

- Vitamin B2 (riboflavin), or the composition comprises it in an amount not exceeding 0.5 mg or not exceeding 0.2 mg, and/or

- Vitamin B3 (niacin), or the composition comprises it in an amount not exceeding 5 mg or not exceeding 2 mg,

furthermore, wherein preferably a composition according to ii) and/or iii) does not comprise

- Vitamin B12 (niacin), or the composition comprises it in an amount not exceeding 5 μg or not exceeding 0,2 μg, and/or

from minerals: - iron

- zinc,

- copper,

additionally one ore more of the following:

- calcium,

- phosphorous,

- magnesium,

- iodine.

Preferably, for the given components, if present, the following statements are true:

- the amount of zinc in a composition of (ii) is at least 1.3 times, preferably 1.4 to 1.6 times higher than the amount of zinc in a composition of (i), and the amount of zinc in a composition of (iii) is at least 1.5 times, preferably 1.6 to 1.8 times higher than the amount of zinc in a composition of (i), wherein preferably the amount of zinc in a composition of (ii) and (iii) is significantly higher, preferably at least by 30%, highly preferably at least by 40%, more preferably at least by 50% higher than in a composition of (i), and/or,

- the amount of copper in a composition of (ii) is at least equal or higher than in a composition of (i), preferably 1.2 times higher than in a composition of (i), and the amount of copper in a composition of (iii) is at least 1.2 times, preferably 1.4 times higher than the amount of copper in a composition of (i), wherein preferably the amount of copper in a composition of (iii) is at least by 5-15% higher than in a composition of (ii) or preferably the amount of copper in a composition of (i) and (ii) is essentially equal or the difference is not higher than 10%, and/or,

- the amount of magnesium in a composition of (i), (ii) and (iii) gradually increases, preferably the amount of magnesium in a composition of (ii) is at least by 1 % or 20%, preferably 25-50% higher than in a composition of (i), and the amount of magnesium in a composition of (iii) is at least by 30%, highly preferably 35-70% or 40-60% higher than in a composition of (i), and preferably the amount in a composition of (i) is at least by 10% or 15%, preferably 10-25%, highly preferably about 15% higher than in a composition of (ii),

highly preferably the amount of magnesium in a composition of (i) is at least 70 mg or 80 mg and not more than 120 mg or 140 mg, in the a composition of (ii) it is at least 90 mg or 110 mg and not more than 130 mg or 160 mg, in a composition of (iii) it is at least 110 mg or 120 mg and preferably at least 130 mg or 140 mg and not more than 160 mg or 180 mg, and preferably in the a composition of (iv) it is at least higher than in any of the compositions (i), (ii) or (iii), or it is essentially equal to that of the a composition of (iii), and/or

- according to a preferred embodiment the amount of phosphorous is essentially equal in all three compositions, and/or the amount of phosphorous is preferably at least 100 mg, or preferably it is about the same in the a composition of (ii) and (iii), wherein each composition preferably provides both phosphorous and calcium,

- the calcium is present in an amount of 100-200 mg in a composition of (i), (ii) and (iii), preferably in gradually increasing amount, however a surplus of calcium can be administered in a separate composition,

- at least a composition of (i), preferably each composition provides folic acid and iron,

- preferably the amount of iron is substantially the same in compositions (i), (ii) and (iii), and/or

- the amount of vitamin A is the lowest in a composition of (i) and preferably the highest in a composition of (iv), highly preferably the amount is increased gradually in compositions (i), (ii), (iii) and (iv), however, the amount of vitamin A present in a composition of (i) does not exceed the 115%, preferably 100% of the recommended daily allowance, in a composition of (ii) it is not higher than 120 %, preferably 115% of the recommended daily allowance, whereas in a composition of (iii) it is not higher than 130 %, preferably 125% of the recommended daily allowance and/or

- the amount of vitamin E is the lowest in a composition of (i) and preferably the highest in a composition of (iv), highly preferably the amount gradually increases in compositions (i), (ii), (iii) and (iv), and/or

- vitamin D, preferably vitamin D3 is present in substantially equal amounts in compositions (i), (ii) and (iii), whereas in a composition of (iv) it is present in at least 1.5 times higher, preferably at least 1.8 times higher, more preferably in at least 1,9 times higher amount than in compositions (i), (ii) and/or (iii), and/or,

- the amounts of vitamin Bl (thiamin) and/or vitamin B2 (riboflavin) are lower in a composition of (i) than in a composition of (ii), and preferably a composition of (iii) does not comprise vitamin Bl (thiamin) and/or vitamin B2 (riboflavin), and or

- the amount of vitamin B3 (niacin) is lower in a composition of (i) than in a composition of

(ii), and preferably a composition of (iii) does not comprise vitar in B3 (niacin), and/or

- the amount of vitamin B6 is substantially equal in compositions (i) and (ii), and the amount of vitamin B6 is higher in a composition of (iii), preferably the amount of vitamin B6 is maximum 6 mg, preferably maximum 4 mg or 3 mg, and/or

- the amount of vitamin B9 (folic acid/folate) is the highest in a composition of (i) and preferably the lowest in a composition of (iii) and/or (iv), and/or

- the amount of vitamin B12 is preferably the highest in a composition of (iv), and preferably compositions (ii) and (iii) do not comprise vitamin B12 (cobalamine)

- the amount of vitamin C is the lowest in a composition of (i) and preferably the highest in a composition of (iii) and/or (iv).

According to a preferred embodiment, in the kit of the invention

a) from the minerals at least zinc and copper, furthermore preferably iron, iodine, magnesium, calcium and phosphorous are present in formulation (packaging) units separated from the others and together with maximum 1 type, 2 types, 3 types, 4 types or 5 types of vitamins, and/or

b) water soluble vitamins and preferably the iron are present in formulation (or packaging) units separated from the others, and or

c) fat soluble vitamins are present in formulation (packaging) units separated from the others.

According to a highly preferable embodiment, in the case of all three compositions, i.e. the compositions of (i), (ii) and (iii) and optionally in case of composition of (iv), the vitamins selected form the following group are present in one of the packaging units: Vitamin A, Vitamin C, Vitamin D3, Vitamin E, Vitamin Bl (thiamine), Vitamin B2 (riboflavin), Vitamin B3 (niacin), Vitamin B6 (pyridoxine), Folic acid, wherein preferably a composition of (iii) does not comprise vitamin Bl (Thiamin), vitamin B2 (Riboflavin) and/or vitamin B3 (Niacin), and wherein preferably compositions (ii) and/or (iii) do not comprise vitamin B12.

According to a highly preferable embodiment, in the case of all three compositions, i.e. compositions of (i), (ii) and (iii) and optionally in case of composition of (iv), the vitamins and minerals selected form the following group are present in the other packaging unit: Biotin, vitamin B 12, iron, iodine, magnesium, calcium, phosphorous, zinc, copper.

According to a further highly preferred embodiment

- the packaging unit (a) is present as a solution, preferably an aqueous solution, highly preferably a solution prepared with mineral water.

- the packaging unit (a) and/or (b) is present in a form of effervescent tablet.

According to a preferred embodiment the kit of the invention comprises at least the following components listed in Table 1.

Table 1

According to a preferred embodiment the kit of the invention comprises at least the following components listed in Table 2. Table 2

The components may be formulated in different combination, e.g. the iron and folic acid are present in a single composition, etc. Each of the minerals may be administered separately or assorted variously. Optionally, the nrineral-containing formulation unit also comprises 1, 2, 3 or 4 types of vitamins, preferably vitamin B7 (biotin) and/or vitamin B12 (cobalamine). Optionally, the composition or a formulation unit is formulated in the form of effervescent tablets or aqueous solutions.

Furthermore the invention relates to any of the compositions of (i) for use in providing vitamin and mineral levels required for this certain period of time in pregnant or lactating mothers being in the 1st trimester of pregnancy.

Furthermore the invention relates to any of the compositions of (ii) for use in providing vitamin and mineral levels required for this certain period of time in pregnant or lactating mothers being in the 2nd trimester of pregnancy.

Furthermore the invention relates to any of the compositions of (iii) for use in providing vitamin and mineral levels required for this certain period of time in pregnant or lactating mothers being in the 3rd trimester of pregnancy, particularly for the purpose of avoiding and/or preventing foetal and/or maternal adiposity or overweight, including adiposity and overweight during the lactation period.

Furthermore the invention relates to any of the compositions of (iv) for use in providing vitamin and mineral levels required for this certain period of time in pregnant or lactating mothers being in the lactation period.

Furthermore, the invention relates to methods for treating pregnant or lactating mothers with the compositions of the invention, where the one or optionally multiple formulation units of the composition is administered to the pregnant or lactating mother, the composition for the given period is ad- ministered in the given period preferably daily, preferably at least for one week, et least for two weeks, at least for one month or at least for two months, or highly preferably during the whole period, however maximum in the whole period (in trimester or during the lactation period).

The term "pregnant or lactating mother" includes pregnant women and lactating women, too. "Adiposity" occurs when a pregnant or lactating mother has an amount of adipose tissues ex- ceeding the normal range.

For a pregnant or lactating mother being in a given period the term "excessive weight gain" means a surplus weight gained compared to the normal body weight (body mass).

The meaning of the terms "comprise" or "include" are not exclusive and permit the addition or inclusion of other features or process steps or ingredients to that which comprises or includes the listed features or process steps or ingredients.

As used herein the terms "comprise" or "include" can be limited to the terms "substantially consisting of and "essentially consisting of the meaning of which is that it comprises compulsory or essential features or process steps or ingredients which are listed in any lists, e.g. in a claim, additionally the presence of further features or process steps or ingredients is allowed which basically do not interfere the basic features of the use, method, composition or the other subject of the invention.

In the description, the singular indefinite articles "a" or "an" used in the various definitions of the invention and, depending on the context, the definite article "the" are to be understood as also including the plural forms, except the context requires otherwise, i.e. for example it is clear that "a single" or "one" to be understood.

DETAILED DESCRIPTION OF THE INVENTION

In the creation of the concept of the invention a family of compositions was considered, the certain elements of which are compositions recommended for the first, second and third trimester of the pregnancy and expediently for the period of lactation. This composition could be accompanied with dietary supplements to be used before conception to precondition the female body for the conception and pregnancy. Since it may not be possible and expedient In all cases to include all vitamins and minerals is a single dose unit, a composition of the family to be used in a certain period would have multiple elements in this case. Upon the determination of the units content, considering the limits of formulation of pharmaceutical compositions, the physiological demands and the consumers' requests could also be considered as discussed below. In such a way an advantage can be made out of the limits of the formu- lation.

According to this concept women being in this important and joyful period of their life and requiring increased care, would not be deceived by stating that a magic capsule solves all their problems, but proposing them a healthy and varied diet, an actually effective balanced dietary supplement would be offered to them. The dietary supplement family of the present concept might be considered as a part of a program emphasizing a healthy pregnant and lactating life style. Additionally, the actually very high doses affect each other effects adversely.

Aspects considering the composition are discussed as follows below or in the Examples. A composition recommendation will also be given in the Examples. Although the specific composition is very important, it is emphasized that the concept of the invention is not limited to a single composition only. Although at the level of the state of the medical art several pieces of knowledge is apparently unquestionable, by having a knowledge about further scientific results the composition - whereas keeping the inventive concept - might be further refined and tailored to the demands of the women's and pregnant or lactating mothers' bodies.

Nevertheless, it should be considered that in the development of the composition it is not enough to consider, in the strict sense, the nutritional aspects only, but special demands of the mothers and foetuses; moreover, the changes occurring during the development of the foetus should also be considered. Accordingly, upon the creation of the invention in the composition of ingredients we have significantly diverged at several important points from a composition constructed primarily on the basis of the state of the art in the dietary or nutritional field, such as:

- the intake of vitamin A was restricted,

- when it was possible the unnecessary vitamin intake was avoided (e.g., the omission of certain vitamin B types in the 3rd trimester is recommended),

- the copper and zinc were considered of great importance in the second and third trimesters since these elements would be responsible for maintaining the normal functioning of the immune system of the body,

- in the third and in lesser degree in the second trimester a significantly elevated magnesium level was used,

- considering the foetal development, a particularly elevated folic acid level was applied in the first, and gradually decreasing folic acid levels were used in the second and third trimesters,

- ratio of the given ingredients were carefully synchronized with each other and with the production criteria.

The inventors have discovered that generally it is not feasible to aim at incorporating all necessary vitamins and minerals into a single composition, formulation or dose unit especially in such an amount that covers itself the RDA. On the other hand, the use of too many formulation forms is also not feasible since it makes the administration of the composition complicate. Therefore, it is preferably recommended that compounds which are chemically, pharmaceutically or medically not or less compatible should not be incorporated to a single formulation.

For example, according to a preferred embodiment the composition family comprises minerals or a part thereof in a separate formulation, and optionally complemented with at mosta few vitamins. It would be hardly accomplished that a single dose unit (such as a capsule or a tablet) would contain the complete recommended daily allowance, furthermore it results practical problems. However, with healthy - mixed - nutrition it is not a task, since it is sufficient to compensate the increased demands. According to a preferred embodiment in the case of further increased requirement the dose could be elevated or multiplied.

Furthermore, according to another preferred embodiment the vitamins will be formulated separately. There is a possibility to formulate the vitamins into two formulation forms, e.g. one for the water soluble and another separate form for the fat soluble vitamins. In other words, vitamins not accumulating in the body are formulated in one form, and a separate form would contain the accumulating vitamins. Accordingly, the doses of the previously mentioned vitamins and minerals can be increased when necessary or in the case of increased deficiency.

In this aspect it is a further advantage that the consumer - expediently on the recommendation of a specialist - could decide whether she purchases only certain members of the composition family. For example, she purchases the mineral supplement and supplies the vitamins probably from another source, or vice versa.

According to a particularly preferred embodiment the minerals or a part of the minerals are formulated separately from the vitamins. Preferably, in the composition-family of the invention the copper and zinc, and preferably the iodine is present in a composition formulated separately.

The composition comprising zinc and copper in amounts essential for preventing premature birth can be taken separately and - when the intake of other minerals and vitamin is adequate or provided from other source - it satisfies this presumption, accordingly this mineral composition is also a member of the composition family. According to a preferred embodiment the composition can be supplemented with iodine. Particularly, this variation can be feasibly used in iodine-deficient areas.

The mineral composition can be formulated in a form of aqueous solutions, preferably in a form of mineral water or enriched mineral water or medicinal water. Particularly preferably the copper and zinc comprising mineral water is optionally supplemented with iodine. The formulation may compris magnesium, or providing it is production technologically possible, the complete kit of trimester vitamins, minerals and trace elements, and consumer, actually the pregnant women, decides which form - i.e. tablet or mineral water - she wants to use for the intake of the daily supplement along with the normal daily diet.

The division among formulation forms of the active ingredients of the composition family would have other, pharmaceutical, biological or marketing aspects.

In the inventive product family a special attention is paid to avoid that the components or the high doses do not impair the effect of each other or to avoid the possible adverse effects. Thus, e.g. it is well known that the too high calcium input decreases the zinc absorption. It is also known that the oil form of omega-3 fatty acids cannot be packed together with certain vitamins. Therefore, according to a preferred embodiment of the composition family, in a separate composition omega-3 fatty acid is added in the amount adequate for the given trimester. (The powder form of omega-3 fatty acid is also known, which - considering production technology - might solve the coexistence with the vitamin family, however, considering the volume it might not be the solution since the composition comprises heavy materials, it is highly packed and the volume is not high enough to incorporate the omega-3 fatty acid). Furthermore, certain intake forms of the omega-3 fatty acids might have allergic effect and this fact supports the advantageous nature of the separate intake. According to a preferred embodi- ment for pregnant women and lactating mothers a composition with high level of omega-3 fatty acids is recommended, wherein the composition comprises at least 400-600 mg of EPA and at least 200- 400 mg of DHA.

Attention is paid to avoid the adiposity and/or extensive weight gain of the pregnant or lactating mothers that affects disadvantegously the quality of life and often the psychical status as well. Furthermore, the foetal adiposity or extensive weight gain are also not advantageous, since in the last trimester the overweighed foetus poses a considerable burden on the maternal body; additionally complications might occur during the birth of such baby. For the pregnant or lactating mother it might be also disadvantageous if the postpartum recovery of weight that corresponds to her condition would delay or would need a hard work (reducing diet, forceful exercise).

Therefore, especially in a composition of (iii) aimed for use in the 3rd trimester the amount of vitamin Bl, B2 and/or B3 is limited preferably under the level of 0.5 mg, 0.5 mg and 5 mg, respectively. Highly preferably the a composition of (ii) and/or (iii) do not comprise vitamins Bl, B2 and/or B3, preferably does/do not comprise any of the three vitamins. According to a further preferred varia- tion a composition of (ii) and/or (iii) does not comprise vitamin B12, preferably none of them comprises vitamin B12.

The normal body weight (body mass) can be calculated by any known method. Indicators possibly useful to assess obesity and/or an abnormal weight gain are for example the "body mass index" (BMI), the "body fat percentage" (BFP) or the "body adiposity index" (BAI). Based on this the nor- mal ranges can be established according to known correlations or tables [see e.g. Global Database on Body Mass Index. WHO. (2006)] Range considered to be normal by the skilled person might change depending on the time, geographical location, and person to person, e.g. on the basis of age, and it can naturally be varies depending on the period of pregnancy or lactation. (For further information, see: Suchanek P„Which index best correlates with body fat mass: BAI, BMI, waist or WHR?" Neuro Endocrinol Lett. (2012) 33 Suppl 2:78-82.]).

With their determined, effective, although relative modest, not too big doses the composition family of the invention provides an opportunity to the specialist or the nurse to recommend the intake of other dietary supplements tailored to the pregnant or lactating mother's needs when necessary.

Furthermore, absorption-helper complexing agents facilitating the absorption in the body may take a role in the food supplement, thus the ingredients can be increasingly utilized. These materials have a positive effect on the absorption in the body, therefore optionally their relatively small dose is sufficient and constitute less burden to the body.

The following possibilities are mentioned as examples only.

Vitamin supplementation is more complicated in certain seasons such as in winter or in early spring time. During these periods increased doses of the composition or its certain elements might be required.

In certain areas or under living conditions (e.g. during winter in Scandinavian countries or when a woman could not leave the home or living place due to a any reason) the adequate vitamin D level could be reduced. In such cases it is enough to increase the vitamin D dose separately. Some instances - e.g. such as cold - it is reasonable to increase the vitamin C intake which can safely and without overloading the excretion system be accomplished separately along with the general, basic vitamin supplement provided by the family of compositions according to the invention.

In certain areas where the drinking water is deficient in iodine the iodine supplement would be problematic, it is enough to ensure the increased iodine supplementation.

In certain patients improved administration of calcium might be necessary for maintaining the health of bones and teeth in such a case it is enough to pay particular attention to the improved calcium supplementation (along with the admnristration of the composition), or later on to compensate the calcium demand with a separate, calcium and vitamin D containing trimester composition.

In certain pregnant or lactating mothers the supplementation of magnesium is often recommended at higher rates than usual. In such cases it is enough to administer the magnesium in higher doses without overloading the body with the other ingredients. Later on the demand might be compensated with trimester composition comprising organic forms of magnesium.

The person skilled in the art knows well the process of multivitamin and mineral product prepa- ration; however, the discovery of the details can be an object of the invention.

The compositions of the invention preferably comprises pharmaceutically acceptable excipi- ents, such as shiner, e.g. stearic acid, anti caking agents, such as silicone dioxide, talcum, other extender, carrier and flavouring agents, e.g. modified dietary starch, sucrose, cornstarch, hydrogenated soy oil, etc.

The amounts can also be expressed in international unit:

The pharmacopoeia give the amounts in the form of International Unit (IU).

Vitarnin A

1 IU = 0.3 μg all-trans-retinol (retinaldehyde)

1 IU = 0.344 μg all-trans-retinol acetate

1 IU = 0.55 μg all-trans-palmitate (retinol palmytate)

1 IU = 1.2 μg alpha carotene, beta cryptoxanthine, likopin, lutein and zeaxanthine

1 IU = 0.6 μg beta-carotene

1 RE (Retinol Equivalent) = 1 μg all-trans-retinol

Vitamin C

1 IU = 50 μg L-ascorbic acid

Vitamin D (Dl ergocalciferol and lumisterol, D2 ergocalciferol, D3 cholecalciferol, D4 22- dihydroergocalciferol, D5 sitocalciferol)

1 IU = 0.025 μg cholecalciferol

Vitamin E (tocopherol E 306, alpha-tocopherol E307, gamma-tocopherol E 308, delta- tocopherol E309)

1 IU = 0.666 mg d-alpha-tocopherol

1 IU = 0.9 mg d-alpha-tocopherol

1 IU = 1 mg dl-alpha-tocopherol acetate

According to an embodiment the ingredients are present in e.g. the following forms: Ingredi- ents: magnesium, iron, copper and/or zinc are, e.g., in a form of malate, citrate, tartarate or gluconate, the calcium is, e.g., in a form of hydrogen phosphate or citrate, ascorbic acid, vitamin A, in a form of tocopherol acetate, pyridoxine in a form of a salt formed with acid, e.g. hydrochloride.

EXAMPLES

Example 1

A preferred variation of the inventive kit of compositions was created considering the following aspects:

1. It is well known that the calcium demand is increased during pregnancy. However, limited amount of calcium can be incorporated into the inventive tablet. Accordingly, in a preferred example 150 mg, 160 mg and 170 mg of calcium is used in the 1 st, 2nd and 3rd trimester, respectively. Where appropriate, a further calcium supplementation can be provided by administering a separate composition.

2. The excessive phosphorous supplement is limited by the tablet volume, however, for a noticeable supplementation the administration of a daily amount of 105 mg phosphorous is recom- mended during the period of pregnancy.

3. The magnesium has muscle relaxant effect, therefore its addition is recommended. In an example a composition comprising increased amount of magnesium is recommended for the 2nd and 3rd trimesters against muscle cramps, the amounts are 130 mg and 150 mg in the 2nd and 3rd trimester, respectively. A supplement of 100 mg is considered to be adequate in the 1st trimester.

4. During pregnancy the elevated maternal blood volume needs iron supplement. Accordingly, during pregnancy altogether a daily 30 mg iron supplement is recommended.

5. The maternal availability to iodine determines the iodine supplement of the foetus. During pregnancy a slightly increasing amount of iodine supplement is recommended, such as in a range from 220 μg to 240 μg. During lactation iodine excreted with the breast milk should also be compen- sated.

6. The toxic limit of zinc is very high, this mineral having antibacterial effect and therefore the increased input of zinc has a role in preventing infections, early membrane rupture and thus the premature birth. Therefore, much higher daily zinc input is recommended in the composition than usual, e.g. for trimester 1 , 2 and 3 daily 10 mg, 15 mg and 17 mg zinc, respectively, are recommended as a supplement.

7. The increased copper input also has infection preventive effect. Since the copper also reduces the risk of early membrane rupture, an unusually high amount such as 1400 g, 1800 μ§ and 200 μg are recommended for the 1st, 2nd and 3rd trimesters, respectively.

8. Vitamin A requirement elevates slightly during pregnancy, while it continues to increase in the lactation period. However, the overdosage of vitamin A represents significant hazards (considering that certain foods also comprise vitamin A supplement), therefore in the composition the upper limit of vitamin A is recommended to be set to a moderate level.

9. Usually the vitamin D demand does not elevate significantly during pregnancy and lactation, however, it is advantageous for the adsorption of calcium and phosphorous. Therefore, considering the maintenance of vitamin D level, the administration of a daily 5 μ of vitamin D3 is recommended.

10. Due to the protection of unsaturated fatty acids the gradual increase of vitamin E is recommended.

1. For the 1st and 2nd trimester, the administration of vitamin Bl (thiamine) and B2 (ribofla- vin) is recommended daily in an amount approximately equal to RDA (for the 2nd trimester the amount can be slightly higher), while for the 3rd trimester preferably the omission of vitamin Bl and B2 is recommended.

12. For the 1 st and 2nd trimester, a daily amount of vitamin B3 (niacin) slightly lower than RDA is recommended in a slightly increasing manner, while for the 3rd trimester preferably the omis- sion of vitamin B3 is recommended.

The vitamins Bl, B2 and B3 (thiamine, riboflavin and niacin) play role in the normal energy producing metabolisms. This process is especially enhanced hormonally in pregnant women. Frequently occurs that - especially in the last trimester - the pregnant or lactating mother's already high appetite increases further and she has a desire for certain foods. Due to the excessive intake of B vi- tamins increased sensation of hunger is developed, and therefore these vitamins can be left out from the trimester 3 composition, thereby protecting the pregnant or lactating mother from an abnormal increase of weight. Thus the correct vitamin distribution can advantageously influence the elevated sense of hunger and with this it helps to protect the excessive weight gain of the pregnant and by this to avoid the birth of extremely big foetuses.

13. The supplementation of vitamin B6 (pyridoxine) is necessary for the entire time. The demand for this vitamine predominantly elevates in the 3rd trimester and during lactation; for these periods a supplement exceeding significantly (approx. by 30-40%) the RDA is recommended.

14. The demand for folic acid increases significantly during pregnancy, however, attention should be paid to avoid overdosing in the 2nd and 3rd trimester. Therefore, departing from conven- tional considerations, a gradually decreasing dose is recommended (e.g., 800 μg, 600 μg and 500 μg in the 1st, 2nd and 3rd trimester, respectively).

15. A gradual but not extreme increase of vitamin B7 (biotin) intake is recommended in trimesters 1-3 from a level below RDA to a level exceeding RDA, whereas a higher amount might be considered during lactation concerning the adequate development of the baby.

16. Vitamin B12 (cobalamine) is considered to be supplemented in the 1st trimester, the 0.5 μ or 10 μg increase is just for safety reasons.

17. Vitamin C (ascorbic acid) provides safe and natural metabolic protection, and increased intensity of the fetal metabolism in comparison with that of the mother. It is not necessary to overload the maternal body and when requested further vitamin C supplement can easily be accomplished. Accordingly, an amount slightly higher than RDA (100-120 mg supplement) is recommended.

Example 2

Trimester 1 product: An effort was made to increase the dose of folic acid due to a specifically increased demand in the first period of the pregnancy - where there is no significant change considering dietary demand and the needs of the body is the same as a person with normal nutrition; the dose was increased to eliminate the neural tube closing abnormalities during the foetal developmental stage; moreover, to supply the body with the appropriate vitamins B for the purpose of alleviating and eliminating nausea and sickness occurring as a consequence of the hormonal changes in the maternal body. To eliminate the early abortions the organic form of zinc and copper has been added however in smaller doses than later on. Presumably the organic form absorbs better than the inorganic ones. The other minerals, trace elements and vitamins considered to be necessary are also present in the composition.

Example 3

Trimester 2 product: This is the subsequent stage of pregnancy covering the period from the end of week 12 to the end of week 27. The demands of the maternal body increase compared with the fact that the foetus extensively develops in this period. In the composition the amounts of vitamins, minerals and trace elements were gradually increased while the amount of folic acid was decreased since in this period there is no need of supplementing it in an elevated dose. The reason of this is that the developmental stage of foetal neural tube terminates in the first trimester. On the other hand, sig- nificant zinc and copper input is recommended, since the risk of abortions and premature births is aimed to decrease by using these two elements.

Example 4

Trimester 3 product:

In this period the foetus gains weight, all of his/her organs have already developed in the previ- ous developmental stages, he/she is viable at the beginning of week 28, and has matured lungs. This the phase of the developmental stage, in which the highest amount of trace elements and mineral supplements are necessary in the maternal body. Significantly increased magnesium intake and, in comparison with trimester 2, further increased intake of copper and zinc aimed at supplementation of deficiencies evolved in the mother's body, an amount she apparently can not supply even with additional food consumption. The supplement of trace elements and minerals - preferably in organically bound, absorbable form - is further considered to be necessary. However, folic acid supplementation, which is not significantly needed in this period, was reduced to the average need of an adult. To avoid the maternal and foetal extreme weight gain the vitamins Bl, B2 and B3 were omitted. For similar reasons vitamin B12 was also omitted.

Example 5

The period of lactation

During the lactation period the demand level of the body significantly changes. For his her development the baby continuously needs all nutrients from the mother's body, and for supplementing this demand the organic, well absorbing forms are recommended. Despite the excessive intake the stores of the mother's body could be deplenished and this could be compensated with continuous replacement. Establishing an optimal balance was attempted.

In the preparation process of the composition the original concept of the invention regarding the composition was maintained, which included the use of organic compound forms which absorb well, incorporate into the mother and utilized by the foetus. Example 6

Example of the composition kit comprising multiple formulation units:

TRIMESTER 1 (Table 3.1)

Ingredients of composition kit recommended for the 1 st trimester:

magnesium citrate, calcium hydrogen phosphate, ferric gluconate, ascorbic acid, shiner (stearic acid), calcium citrate, zinc citrate, modified starch, dl-alpha-tocopherol acetate, nicotinamide, copper gluconate, stabilizer (polyvinyl pyrrolidone), saccharose (1.45 mg/tablet), maltodextrin, anti caking agent (magnesium stearate), pyridoxine hydrochloride, gelatine, thiamine monohydrate, riboflavin, retinil acetate, folic acid, hydrolyzed gelatine, potassium iodate, cornstarch, hydrogenated soy oil, D- biotin, cholecalciferol, cyanocobalamine (Vitamin B 12).

TRIMESTER 2 (Table 3.2)

Ingredients of composition kit recommended for the 2nd trimester:

magnesium citrate, calcium hydrogen phosphate, ferric gluconate, ascorbic acid, shiner (stearic acid), zinc citrate, modified starch, dl-alpha-tocopherol acetate, nicotinamide, copper gluconate, stabilizer (polyvinyl pyrrolidone), anti caking agent (magnesium stearate), saccharose (1.57 mg/tablet), pyridoxine hydrochloride, riboflavin, thiamine monohydrate, gelatine, retinil acetate, hydrolyzed gelatine, folic acid, potassium iodate, cornstarch, hydrogenated soy oil, D-biotin, cholecalciferol. TRIMESTER 3 (Table 3 J)

Ingredients of composition kit recommended for the 3rd trimester:

magnesium citrate, calcium hydrogen phosphate, ferric gluconate, calcium citrate, ascorbic acid, shiner (stearic acid), zinc citrate, modified starch, dl-alpha-tocopherol acetate, copper gluconate, stabilizer (polyvinyl pyrrolidone), anti caking agent (magnesium stearate), saccharose (1.7 mg/tablet), pyridoxine hydrochloride, gelatine, retinil acetate, folic acid, hydrolyzed gelatine, cornstarch, hydro- genated soy oil, D-biotin, colecalciferol.

INDUSTRIAL APPLICABILITY

Instead of composition of the inventional composition family:

Inventional product family with compositions varying according to each trimesters might have the advantages as follows:

They are capable of supplementing the necessary vitamins and trace elements optimally, targeted and consistently during the trimesters and the lactation.

During the specific stages of pregnancy, the trimester product line may be capable of ensuring the amount of supplements necessary for the initial developmental stage of the foetus and for eliminating the risk of neural tube defect as well as alleviating or eliminating the mother's temporary indispositions and the inconvenient symptoms arising from the deficiencies in her body.

A closer attention paid to the mother's and the foetus' demands will presumably result in the elimination of the earlier practice of continuous and regular supplement supply, the consequences of which may result in babies with high birth weight and in the excessive weight gain of the mother.

The copper and zinc were considered as elements of great importance in the second and third trimesters since these elements can be held responsible for maintenance of the normal functions of the body's immune system thus providing a protection for the mother's body, an antibacterial effect that maintains the normal vaginal flora and they also eliminate superinfections leading to early abortion or premature birth. The elevated magnesium level in the third trimester is aimed to ensure the symptoms of magnesium deficiency occurring in the pregnant's body, such as leg cramps, muscle cramps, symptoms which indicate the magnesium deprivation. Accordingly, the elevated level might prevent the regular uterine contractions which, in the absence of magnesium supplement, can initiate the predictive contractions, extensive pains and uterine contractions, cramps, all of which might lead to labour, premature birth or abortion.

Claims

1. Kit of vitamin and/or mineral compositions for maintaining physiologically healthy levels of vitamin and/or minerals in pregnant or lactating mothers, said kit comprising at least the following compositions:

i) a vitamin and/or mineral composition, or a set of said compositions consisting of multiple formulation units, for use in the period of 1 st trimester of the pregnancy of a pregnant or lactating mother,

ii) a vitamin and/or mineral composition, or a set of said compositions consisting of multiple formulation units, for use in the period of 2nd trimester of the pregnancy of a pregnant or lactating mother,

iii) a vitamin and/or mineral composition or a set of said compositions consisting of multiple formulation units, for use in the period of 3rd trimester of the pregnancy of a pregnant or lactating mother, and optionally

iv) a vitamin and/or mineral composition, or a set of said compositions consisting of multiple formulation units for use in the lactation period of a pregnant or lactating mother.

2. The kit according to claim 1, wherein the compositions comprise - independently of each other and in accordance with the periods - at least the following:

from fat-soluble vitamins:

- Vitamin E,

- Vitamin D,

preferably additionally one ore more of the following:

- Vitamin A,

and/or

from water-soluble vitamins:

- Vitamin B9 (folic acid/folate),

preferably additionally one ore more of the following:

- Vitamin C,

- Vitamin Bl (thiamine),

- Vitamin B2 (riboflavin),

- Vitamin B3 (niacin),

- Vitamin B6 (pyridoxine),

- Vitamin B7 (biotin),

wherein the composition of (iii) does not contain:

furthermore wherein preferably the compositions of (ii) and/or (iii) do not contain Vitamin Bl 2, or the compositions comprises it in an amount not exceeding 5 μg or not exceeding 0,2 μg,

and/or

from minerals:

- iron

- zinc,

- copper,

and preferably additionally one ore more of the following:

- calcium,

- phosphorous,

- magnesium,

- iodine.

3. The kit of claim 2, wherein the following statements are true for each component (if present): - the amount of zinc in a composition of (ii) is at least 1.3 times, preferably 1.4 to 1.6 times higher than the amount of zinc in a composition of (i), and the amount of zinc in a composition of (iii) is at least 1.5 times, preferably 1.6 to 1.8 times higher than the amount of zinc in a composition of (i), wherein preferably the amount of zinc in a composition of (ii) and (iii) is significantly higher, preferably at least by 30%, highly preferably at least by 40%, more preferably at least by 50% higher than in a composition of (i), and/or,

- the amount of copper in a composition of (ii) is at least equal or higher than in a composition of (i), preferably at least 1.2 times higher than in a composition of (i), and the amount of copper in a composition of (iii) is at least 1.2 times, preferably at least 1.4 times higher than the amount of copper in a composition of (i), and the amount of copper in a composition of (iii) is highly preferably at least by 5-15% higher than in a composition of (ii) or preferably the amount of copper in a composition of (i) and (ii) is essentially equal or the difference is not higher than 10%, and/or,

- the amount of magnesium in a composition of (i), (ii) and (iii) gradually increases, preferably the amount of magnesium in a composition of (ii) is at least by 15% or 20%, preferably 25-50% higher than in a composition of (i), and the amount of magnesium in a composition of (iii) is at least by 30%, highly preferably 35-70% or 40-60% higher than in a composition of (i), and preferably the amount in a composition of (iii) is at least by 10% or 15%, preferably 10-25%, highly preferably about 15% higher than in a composition of (ii),

highly preferably the amount of magnesium in a composition of (i) is at least 70 mg or 80 mg and not more than 120 mg or 140 mg, in the a composition of (ii) it is at least 90 mg or 1 10 mg and not more than 130 mg or 160 mg, in a composition of (iii) it is at least 1 10 mg or 120 mg and preferably at least 130 mg or 140 mg and not more than 160 mg or 180 mg, and preferably in the a composition of (iv) it is at least higher than in any of the compositions (i), (ii) or (iii), or it is essentially equal to that of the a composition of (iii), and/or

- according to a preferred embodiment the amount of phosphorous is essentially equal in all three composition, and highly preferably it is at least 90 mg, preferably at least 100 mg, or preferably it is about the same in the composition of (ii) and (iii), wherein each composition preferably provides both phosphorous and calcium.

- the calcium is present in an amount of 100-200 mg in a composition of (i), (ii) and (iii), pref- erably in gradually increasing amount, however a surplus of calcium can be administered in a separate composition,

- the amount of vitamin A is the lowest in a composition of (i) and preferably the highest in a composition of (iv), highly preferably the amount is increased gradually in compositions of (i), (ii),

(iii) and (iv), however the amount of vitamin A present in a composition of (i) does not exceed the 115%, preferably 100% of the recommended daily allowance, in a composition of (ii) it is not higher than 120 %, preferably 1 15% of the recommended daily allowance, whereas in a composition of (iii) it is not higher than 130 %, preferably 125% of the recommended daily allowance and/or

preferably

- vitamin D, preferably vitamin D3 is present in substantially equal amount in compositions (i), (ii) and (iii), whereas in a composition of (iv) it is present at least 1.5 times higher, preferably at least

1.8 times higher, more preferably at least 1,9 higher amount than in compositions (i), (ii) and/or (iii), and/or,

- the amounts of vitamin Bl (thiamin) and/or vitamin B2 (riboflavin) are lower in a composition of (i) than in a composition of (ii), and preferably a composition of (iii) does not comprise vita- min Bl (thiamin) and/or vitamin B2 (riboflavin), and or

- the amount of vitamin B3 (niacin) is lower in a composition of (i) than in a composition of (ii), and preferably a composition of (iii) does not contains vitamin B3 (niacin), and or

- the amount of vitamin B12 is preferably the highest in a composition of (iv), and preferably compositions of (ii) and (iii) do not contain vitamin B12 (cobalamine)

4. The kit of any of claims 1 to 3, wherein

a) among minerals at least zinc and copper, furthermore preferably iron, iodine, magnesium, calcium and phosphorous are present in formulation units separated from the others and together with maximum 1 type, 2 types. 3 types, 4 types or 5 types of vitamins, and/or

b) water soluble vitamins and preferably iron are present in packaging units separate from the others, and/or

c) fat soluble vitamins are present in packaging units separate from the others.

5. The composition of claim 4, wherein

- the packaging unit according to (a) is present as a solution, preferably as an aqueous solution, highly preferably as a solution prepared with mineral water.

- the packaging unit according to (a) and/or (b) is present in a form of effervescent tablet.

6. The kit of any of claims 2 to 5 which comprises at least the components listed in the following table.

7. The kit of claim 6, wherein said kit comprises at least the components listed in the following table:

1st trimester 2nd trimester 3rd trimester Lactation

A (β-carotene) 700-850 μg 700-950 μg 700-1050 ig 700-1150 μ_ξ

D 2-9 μ_δ 2-9 μ_§ 2-9 μ_§ 8-20 μ§

E 10-15 mg 13-17 mg 14-18 mg 15-20 mg

Bl (thiamin) 0.8-1.2 mg 1-1.4 mg - 1.2-1.6 mg B2 (riboflavin) 1-1.4 mg 1.3-1.7 mg 1.4-1.8 mg

B3 (niacin) 10-15 mg 13- 17 mg - 15-20 mg

B6 (pyridoxine) 1.4-1.8 mg 1.4-1.8 mg 1.6-2.2 mg 1.6-2.2 mg

B9 (folic acid/folate) 650-900 g 200-650 g 200-600 μg 500-700 μg

B7 (biotin) 30-50 μg 40-60 μg 50-70 μ§ 50-70

B12 (cobalamine) 2-5 μ₈ - - 3-6 μg

C 50-150 mg 60- 160 mg 70-170 mg 80-200 mg

Iron 20-50 mg 20-50 mg 20-50 mg 10-40 mg

Calcium 200-300 mg 250 mg 250 mg 250 mg

Phosphorous 100-150 mg 100-200 mg 100-200 mg 150-250 mg

Magnesium 50-150 mg 130-200 mg 130-200 mg 100-200 mg

Iodine 190-250 μ_δ 200-260 210-270 μ 230-300 μg

Zinc 9-15 mg l l- 18 mg 14-22 mg 7-16 mg

Copper 1.4-1.8 mg 1.5-2.0 mg 1.5-2.0 mg 1-1.4 mg

8. The kit of any of claims 1 to 7, wherein said kit is a food supplement or formulated in a form of food supplement.

9. The kit of any of claims 1 to 7, wherein said kit is a medicament or formulated in a form of medicament.

10. The kit of any of claims 1 to 9, wherein one or more formulation unit is present in a form selected from the following group: tablet, capsule, effervescent tablet, solution, preferably drink.

11. The kit of any of the previous claims characterized in that the compositions of (iii) do not contain:

- Vitamin Bl (thiamine),

- Vitamin B2 (riboflavin) and/or,

- Vitamin B3 (niacin),

furthermore wherein, preferably the composition of ii) and/or iii) do not contain vitamin B 12.

12. The composition of (i) determined in any of claims 1 to 10 for use in pregnant or lactating mothers being in the 1st trimester of pregnancy.

13. The composition of (ii) determined in any of claims 1 to 10 for use in pregnant or lactating mothers being in the 2nd trimester of pregnancy.

14. The composition of (iii) determined in any of claims 1 to 11 for use in pregnant or lactating mothers being in the 3rd trimester of pregnancy, preferably for use in avoiding and/or preventing extreme foetal and/or maternal obesity or extreme weight gain.

15. The composition of (iv) determined in any of claims 1 to 10 for use in lactating pregnant or lactating mothers.