Clinical trial NCT02300948: Optimizing Periconceptional and Prenatal Folic Acid Supplementation
Official title: Optimizing Periconceptional and Prenatal Folic Acid Supplementation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Pregnancy
Keywords: Pregnancy
Perinatal Vitamins
folate
Lead sponsor: The Hospital for Sick Children
Sponsor class: OTHER
Collaborators: name: Duchesnay Inc.
First posted: 2014-11-25
Enrollment: 83
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: 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)

Primary outcomes:
measure: The serum folate pharmacokinetics in healthy, non-pregnant women of childbearing age who ingest a single evening dose of PregVit-folic 5® (5 mg folic acid) versus a single evening dose of PregVit® (1.1 mg folic acid).
timeFrame: 1 day
measure: The steady-state red blood cell and serum folate levels achieved in healthy, non-pregnant women of childbearing age who supplement daily for 30 weeks with PregVit-folic 5® versus PregVit®.
timeFrame: 6 days
measure: The steady-state periconceptional and gestational red blood cell and serum folate levels in women planning a pregnancy or early in pregnancy (<6 weeks gestation) who supplement daily with PregVit-folic 5® versus PregVit®.
timeFrame: 4 days
Secondary outcomes:
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: The Hospital for Sick Children
state: Ontario
Study officials:
affiliation: The Hospital for Sick Children, Toronto Canada
name: Gideon Koren, MD
role: PRINCIPAL_INVESTIGATOR
References: