Overview

This trial is active, not recruiting.

Condition pregnancy
Treatments vitamin b12, placebo
Phase phase 3
Sponsor Harvard School of Public Health
Collaborator St. John's Research Institute
Start date December 2008
End date April 2019
Trial size 366 participants
Trial identifier NCT00641862, HD052143

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose treatment
Arm
(Active Comparator)
Vitamin B12
vitamin b12
Daily oral administration of 50 µg of Vitamin B12 taken from enrollment (at or before 14 weeks gestational age) until delivery
(Placebo Comparator)
Placebo
placebo
Placebo taken daily from enrollment (at or before 14 weeks gestational age) until delivery

Primary Outcomes

Measure
Changes in maternal serum B12 concentration from 1st to 3rd trimester
time frame: from 1st to 3rd trimester

Secondary Outcomes

Measure
Changes in maternal hemoglobin levels, maternal weight gain and infant birth-weight.
time frame: Maternal hemoglobin levels will be assessed at weeks 24 and 34 pre-pregnancy and at 6 weeks post-partum. Maternal weight gain will be assessed monthly until delivery and at 6 weeks post-partum. Infant birth-weight will be assessed at birth.
Childhood neurodevelopment/neurocognitive function
time frame: 18 and 30 months

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - Pregnant women at or before 14 weeks gestational age. Exclusion Criteria: - Women who anticipate moving outside of the study area before study completion - Those with twin or multiple pregnancies - Those who test positive for hepatitis B (HepBSAg), HIV or Syphilis (VDRL) - Those taking vitamin supplements in addition to folate and iron - Those with a serious pre-existing medical condition, defined as conditions that require chronic or daily medical therapy such as connective tissue diseases, hypertension not related to pregnancy, inflammatory bowel disease, active tuberculosis, symptomatic heart disease, and insulin dependent diabetes.

Additional Information

Official title Randomized Trial of Vitamin B12 in Pregnant Indian Women
Principal investigator Christopher P Duggan, MD, MPH
Description The incidence of poor fetal growth and adverse maternal and infant birth outcomes is quite high in India, and several lines of evidence suggest that maternal nutritional status may be an important factor. We have previously performed extensive evaluations of poor fetal and infant outcomes in other settings, and found that maternal micronutrient supplementation (B vitamins including vitamin B12, plus vitamins C and E) in HIV positive Tanzanian mothers decreased the risk of low birthweight (<2500 g) by 44% (RR (95% CI) 0.56 (0.38-0.82)), severe preterm birth (<34 weeks of gestation) by 39% (RR 0.61 (0.38-0.96)), and small size for gestational age at birth by 43% (RR 0.57 (0.39-0.82)). In a prospective cohort study of 410 pregnant Indian women, we recently found a strong relationship between maternal serum vitamin B12 concentration and risk of infant intrauterine growth retardation (IUGR). Compared to women in the highest tertile of serum B12 concentration, women in the lowest tertile were significantly more likely to have IUGR infants, after controlling for maternal age, weight, education, and parity (OR (95% CI) 5.98 (1.72-20.74)). We now propose a randomized, double-blind trial among 300 pregnant Indian women in order to determine the effectiveness of vitamin B12 supplementation (50 µg daily) in improving maternal B12 status. Secondary aims for this exploratory 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. The study will be a collaborative effort between the Division of Nutrition, St John's Research Institute, Bangalore, India, and the Department of Nutrition, Harvard School of Public Health, Boston, US.
Trial information was received from ClinicalTrials.gov and was last updated in July 2015.
Information provided to ClinicalTrials.gov by Harvard School of Public Health.