Optimizing Periconceptional and Prenatal Folic Acid Supplementation
Optimizing Periconceptional and Prenatal Folic Acid Supplementation
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®.
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.
Inclusion Criteria:

 -  Any healthy, non-pregnant, fertile woman between 18 and 45 years of age.(Part 1 and 2)

 -  Have not taken multivitamins or folic acid supplements in the past 6 months. (Part 1
 and 2)

 -  Healthy women between 18 to 45 years of age.(For Part 3)

 -  Planning a pregnancy, or within the first 2 weeks of missing a menstrual period, or
 within the first 6 weeks of pregnancy.(Part 3)

 -  Have not taken multivitamins or folic acid supplements in the past 6 months.(Part 3)

 Exclusion Criteria:

 -  Have hypersensitivities to the ingredients in PregVit-folic 5® or PregVit®. (Part 1, 2
 and 3)

 -  Have chronic medical conditions (i.e. hypertension, diabetes, epilepsy, irritable
 bowel syndrome, hypo/hyper-thyroidism, depression). (Part 1, 2 and 3)

 -  Chronic use (i.e. long-term, specifically prescribed dose) of oral medications (i.e.
 oral contraceptives, anticonvulsants, antibiotics, antidepressants).(Part 1, 2 and 3)

 -  Have a family history or previous pregnancy affected by NTDs.(Part 1, 2 and 3)

 -  Do not agree to the protocol.(Part 1, 2 and 3)