NOVEL FLUORIDE PRENATAL DIETARY SUPPLEMENT

20230061061 · 2023-03-02

    Inventors

    Cpc classification

    International classification

    Abstract

    The presently disclosed subject matter provides compositions, kits, and methods for administering a prenatal dietary supplement comprising at least about 3 mg of bioavailable, fluoride to a pregnant woman.

    Claims

    1-16. (canceled)

    17. A method for increasing the length of gestation of a fetus, the method comprising administering to a pregnant woman a prenatal dietary supplement comprising a source of fluoride in an amount effective to provide between about 3 mg to about 5 mg of bioavailable fluoride and an amount of calcium that is between about 0.01 and 1% of the total weight of the prenatal dietary supplement, wherein administration of the supplement increases the length of gestation of the fetus.

    18. The method of claim 17, wherein the amount effective comprises about 6.6 mg of the source of the fluoride.

    19. The method of claim 17, wherein the supplement comprises a source of calcium that does not complex with fluoride to reduce the bioavailability of the fluoride.

    20. The method of claim 17, wherein the prenatal dietary supplement is administered when the pregnant woman has an empty stomach or has previously ingested water.

    21. The method of claim 17, wherein the prenatal dietary supplement is administered (a) when the pregnant woman has an empty stomach or has previously ingested water; (b) at least 3 or at least 4 hours before, or at least 1 hour after, the pregnant woman consumes a food, beverage, or other supplement comprising calcium; (c) at night; (d) once every 24 hours; (e) during the second and/or third trimester of pregnancy; or (f) from the 12th week of pregnancy until the pregnant woman gives birth.

    22. A method for changing the natural microbiome of a pregnant woman, the method comprising administering a pregnant woman a prenatal dietary supplement comprising a source of fluoride in an amount effective to provide about 3 mg to about 5 mg of bioavailable fluoride and an amount of calcium that is between about 0.01 and 1% of the total weight of the prenatal dietary supplement, wherein administration of the supplement changes the natural microbiome of the pregnant woman.

    23. The method of claim 22, wherein the natural microbiome comprises a microbiome of the oral cavity, genital tract, and/or gastrointestinal tract of the pregnant woman.

    24. The method of claim 22, wherein the amount effective comprises about 6.6 mg of the source of the fluoride.

    25. The method of claim 22, wherein the supplement comprises a source of calcium that does not complex with fluoride to reduce the bioavailability of the fluoride.

    26. The method of claim 22, wherein the prenatal dietary supplement is administered when the pregnant woman has an empty stomach or has previously ingested water.

    27. The method of claim 22, wherein the prenatal dietary supplement is administered (a) when the pregnant woman has an empty stomach or has previously ingested water; (b) at least 3 or at least 4 hours before, or at least 1 hour after, the pregnant woman consumes a food, beverage, or other supplement comprising calcium; (c) at night; (d) once every 24 hours; (e) during the second and/or third trimester of pregnancy; or (f) from the 12th week of pregnancy until the pregnant woman gives birth.

    28. A method for protecting a pregnant woman and her fetus against transient bacteremia and/or ascending infection, the method comprising administering a pregnant woman a prenatal dietary supplement comprising a source of fluoride in an amount effective to provide about 3 mg to about 5 mg of bioavailable fluoride and an amount of calcium that is between about 0.01 and 1% of the total weight of the prenatal dietary supplement, wherein administration of the supplement protects the pregnant woman and her fetus against transient bacteremia and/or ascending infection.

    29. The method of claim 28, wherein the amount effective comprises about 6.6 mg of the source of the fluoride.

    30. The method of claim 28, wherein the supplement comprises a source of calcium that does not complex with fluoride to reduce the bioavailability of the fluoride.

    31. The method of claim 28, wherein the prenatal dietary supplement is administered when the pregnant woman has an empty stomach or has previously ingested water.

    32. The method of claim 28, wherein the prenatal dietary supplement is administered (a) when the pregnant woman has an empty stomach or has previously ingested water; (b) at least 3 or at least 4 hours before, or at least 1 hour after, the pregnant woman consumes a food, beverage, or other supplement comprising calcium; (c) at night; (d) once every 24 hours; (e) during the second and/or third trimester of pregnancy; or (f) from the 12th week of pregnancy until the pregnant woman gives birth.

    Description

    EXAMPLES

    [0070] The following Examples have been included to provide guidance to one of ordinary skill in the art for practicing representative embodiments of the presently disclosed subject matter. In light of the present disclosure and the general level of skill in the art, those of skill can appreciate that the following Examples are intended to be exemplary only and that numerous changes, modifications, and alterations can be employed without departing from the scope of the presently disclosed subject matter. The following Examples are offered by way of illustration and not by way of limitation.

    Example 1

    Exemplary Ranges of Amounts of Compounds in a Prenatal Dietary Supplement

    [0071] In this Example, some exemplary ranges of amounts of compounds in an embodiment of a presently disclosed dietary supplement are shown in Table 1.

    TABLE-US-00001 TABLE 1 Ranges of amounts of compounds Compound Range Source of fluoride 6-11 mg Vitamin C 0-2000 mg Vitamin B.sub.1 0-100 mg Vitamin B.sub.2 0-60 mg Vitamin B.sub.3 0-35 mg Vitamin B.sub.5 0-100 Vitamin B.sub.6 0-50 mg Vitamin B.sub.12 0-150 μg Folic acid 0-1 mg Magnesium sulfate 0-69 mg Zinc 0-40 mg Copper 0-10 mg Manganese sulfate 0-13 mg

    Example 2

    [0072] Exemplary Embodiment of a Prenatal Dietary Supplement In this Example, some exemplary amounts of compounds in an embodiment of a presently disclosed dietary supplement are shown in Table 2.

    TABLE-US-00002 TABLE 2 Amounts of compounds in an exemplary embodiment Compound Amount Source of fluoride 6.6 mg Vitamin C 200 mg Vitamin B.sub.1 10 mg Vitamin B.sub.2 6 mg Vitamin B.sub.3 30 mg Vitamin B.sub.5 10 mg Vitamin B.sub.6 5 mg Vitamin B.sub.12 15 μg Folic acid 1 mg Magnesium sulfate 6.9 mg Zinc 18.2 mg Copper 0.8 mg Manganese sulfate 1.3 mg

    REFERENCES

    [0073] All publications, patent applications, patents, and other references mentioned in the specification are indicative of the level of those skilled in the art to which the presently disclosed subject matter pertains. All publications, patent applications, patents, and other references are herein incorporated by reference to the same extent as if each individual publication, patent application, patent, and other reference was specifically and individually indicated to be incorporated by reference. It will be understood that, although a number of patent applications, patents, and other references are referred to herein, such reference does not constitute an admission that any of these documents forms part of the common general knowledge in the art.

    [0074] Although the foregoing subject matter has been described in some detail by way of illustration and example for purposes of clarity of understanding, it will be understood by those skilled in the art that certain changes and modifications can be practiced within the scope of the appended claims.