drugset / Trial / NCT02300948
Optimizing Periconceptional and Prenatal Folic Acid Supplementation
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | PregVit-folic 5® | Unknown | 5 mg | Oral |
| Comparator | PregVit® | Other / unclassified | 1.1 mg | Oral |