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Optimizing Periconceptional and Prenatal Folic Acid Supplementation

NCT02300948 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 83

Last updated 2014-11-25

No results posted yet for this study

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®.

Conditions

  • Pregnancy

Interventions

DRUG

PregVit® contains 1.1 mg of folic acid

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.

DRUG

PregVit-folic 5® contains 5 mg of folic acid

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.

Sponsors & Collaborators

  • Duchesnay Inc.

    collaborator INDUSTRY

  • The Hospital for Sick Children

    lead OTHER

Principal Investigators

  • Gideon Koren, MD · The Hospital for Sick Children, Toronto Canada

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2006-12-31
Primary Completion
2013-02-28
Completion
2013-04-30

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02300948 on ClinicalTrials.gov