Randomized Trial of Vitamin B12 in Pregnant Indian Women

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

366 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-12-31

Study Completion Date

2011-01-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Pregnancy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Vitamin B12

Group Type ACTIVE_COMPARATOR

Vitamin B12

Intervention Type DIETARY_SUPPLEMENT

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

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

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

Interventions

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Vitamin B12

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

Intervention Type DIETARY_SUPPLEMENT

Placebo

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

Intervention Type OTHER

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No