MedTrace Logo

Randomized Trial of Vitamin B12 in Pregnant Indian Women

NCT00641862 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 366

Last updated 2020-07-28

Study results available
· View outcomes & findings →

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.

Conditions

  • Pregnancy

Interventions

DIETARY_SUPPLEMENT

Vitamin B12

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

OTHER

Placebo

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

Sponsors & Collaborators

  • St. John's Research Institute

    collaborator OTHER

  • Harvard School of Public Health (HSPH)

    lead OTHER

Principal Investigators

  • Christopher P Duggan, MD, MPH · Harvard School of Public Health (HSPH)

  • Anura Kurpad, MBBS, PhD · St. John's Research Institute

  • Krishnamachari Srinivasan, MD · St. John's Research Institute

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-12-31
Primary Completion
2011-01-31
Completion
2011-01-31

Countries

  • India

Study Locations

More Related Trials

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 NCT00641862 on ClinicalTrials.gov