Optimizing Periconceptional and Prenatal Folic Acid Supplementation

PHASE4CompletedINTERVENTIONAL
Enrollment

83

Participants

Timeline

Start Date

December 31, 2006

Primary Completion Date

February 28, 2013

Study Completion Date

April 30, 2013

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.

Trial Locations (1)

M5G 1X8

The Hospital for Sick Children, Toronto

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Duchesnay Inc.

INDUSTRY

lead

The Hospital for Sick Children

OTHER

NCT02300948 - Optimizing Periconceptional and Prenatal Folic Acid Supplementation | Biotech Hunter | Biotech Hunter