CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 366 enrolled
Drug / intervention
Vitamin B12 +1 moredietary
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00641862
NCT00641862N/ACompleted
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Randomized Trial of Vitamin B12 in Pregnant Indian Women

Harvard School of Public Health (HSPH)·interventional·Posted Mar 24, 2008·Updated Jul 28, 2020

In Brief

A clinical study evaluating Vitamin B12 and Placebo for Pregnancy. Completed, enrolled 366 participants across 1 site.

Detailed Summary

This study is a randomized, double-blind trial among 300 pregnant Indian women in order to determine the effectiveness of vitamin B12 supplementation in improving maternal B12 status. Secondary aims for this trial include maternal hemoglobin, maternal weight gain during pregnancy and infant birthweight. All women will receive standard of prenatal obstetric care, including routine supplementation with iron and folate.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPregnancy
CountriesIndia
CollaboratorsSt. John's Research Institute

Timeline

N/ACompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedMar 24, 2008
Enrollment StartDec 1, 2008
Primary CompletionJan 1, 2011
TodayJul 2, 2026
Enrollment to primary: 2.1 yearsPosted 18.3 years ago

Interventions

Vitamin B12dietary

Daily oral administration of 50 µg of Vitamin B12 taken from enrollment (at or before 14 weeks gestational age) until delivery

Placeboother

Placebo taken daily from enrollment (at or before 14 weeks gestational age) until delivery