Optimizing Periconceptional and Prenatal Folic Acid Supplementation
Condition: Pregnancy
Study type: Interventional
Phase: Phase 4

Summary: 
      There are three objectives in this study:

        1. To assess the serum folate pharmacokinetics of ingesting a single dose of
           PregVit-Folic5® versus a single dose of PregVit® (a multivitamin containing 1.1 mg folic
           acid)

        2. To assess the steady-state red blood cell (RBC) and serum folate concentrations achieved
           in non-pregnant, fertile women who supplement daily with PregVit-Folic5® versus PregVit®

        3. To assess the steady-state RBC and serum folate concentrations achieved before and
           during pregnancy in women planning a pregnancy or early in pregnancy (<6 weeks
           gestation) who supplement daily with PregVit-Folic5® versus PregVit®.
    

Detailed description: 
      A prospective, randomized, 2-arm, interventional study involving women of child-bearing age
      will compare the folate status and pharmacokinetics of PregVit-Folic5® and PregVit®.

      Some women of childbearing age, particularly those who do not practice multivitamin
      supplementation, may have inadequate intake and blood concentrations of vitamins and
      minerals, including those micronutrients which are important in pregnancy. Folic acid is one
      of the important vitamins in pregnancy which can be obtained from folate-rich foods, folic
      acid-fortified foods, and multivitamins. It is important to examine the folate status of
      fertile women, who do not usually practice multivitamin supplementation, before and after
      they implement folic acid containing-multivitamin supplementation.

      The investigators wish to measure red blood cell and serum folate concentrations among women
      who are healthy and/or childbearing age, those planning a pregnancy or early in pregnancy (<
      6 weeks gestation) and who do not practice multivitamin supplementation. The investigators
      would like to measure and compare folate levels among women before and after implementing
      multivitamin supplementation with either PregVit® or PregVit-Folic 5®. This may be important
      information for planning or pregnant women who need folic acid, which has been shown to
      reduce the risk of neural tube defects and potentially other malformations as well.

      The Study hypotheses are as follows:

        1. The serum folate concentration from ingesting PregVit-folic 5® (5 mg folic acid) will be
           4-5 fold larger compared to that of PregVit® (1.1 mg folic acid).

        2. Non-pregnant women of childbearing age who supplement daily with PregVit-folic 5® will
           invariably and optimally achieve and maintain maximum protective blood folate levels
           (i.e. ≥900 nM red blood cell folate) against NTDs.

        3. Women planning a pregnancy or early in pregnancy (<6 weeks gestation) who supplement
           daily with PregVit-folic 5® will invariably and optimally achieve and maintain maximum
           protective blood folate levels (i.e. ≥ 900 nM red blood cell folate) against NTDs before
           and during pregnancy.
    

Intervention name(s): PregVit® contains 1.1 mg of folic acid; PregVit-folic 5® contains 5 mg of folic acid
Intervention type(s): Drug; Drug
Intervention description(s): Participants are randomly allocated to one of two groups: PregVit-Folic 5® (group1) contains 5 mg folic acid or PregVit® (group 2) contains 1.1 mg folic acid.Both supplements are taken as 2 tablets daily, one tablet in the morning (am) and one tablet in the evening (pm). Both multivitamins are appropriate for periconceptional, prenatal, and post-partum supplementation. The total volume of blood that will be taken is approximately 20 mL (4 teaspoons). Each appointment will be scheduled according to when participants are available. To monitor adherence, the PregVit-Folic 5® blister packs should be returned among with a diary of pill intake (will be provided). To document dietary folate, telephone interviews regarding the diet will be conducted.; Participants are randomly allocated to one of two groups: PregVit-Folic 5® (group1) contains 5 mg folic acid or PregVit® (group 2) contains 1.1 mg folic acid.Both supplements are taken as 2 tablets daily, one tablet in the morning (am) and one tablet in the evening (pm). Both multivitamins are appropriate for periconceptional, prenatal, and post-partum supplementation. The total volume of blood that will be taken is approximately 20 mL (4 teaspoons). Each appointment will be scheduled according to when participants are available. To monitor adherence, the PregVit-Folic 5® blister packs should be returned among with a diary of pill intake (will be provided). To document dietary folate, telephone interviews regarding the diet will be conducted.
Other intervention name(s): Pregvit®; PregVit Folic 5®
Intervention MeSH terms: Folic Acid; Vitamin B Complex
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Pregnancy; Perinatal Vitamins; folate