drugset / Trial / NCT02300948

Optimizing Periconceptional and Prenatal Folic Acid Supplementation

NCT02300948 ↗

RandomizedParallel-groupOpen-labelTreatment

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®.

Timeline

Start
2006-12
Primary completion
2013-02
Completion
2013-04

Drugs

EvaluationDrugModalityDoseRoute
Subject PregVit-folic 5® Unknown 5 mg Oral
Comparator PregVit® Other / unclassified 1.1 mg Oral

Indications