Official Title: “Randomized Trial of Vitamin B12 in Pregnant Indian Women”

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 Type: Interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Efficacy Study

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.

Intervention(s) in this Clinical Trial

• Dietary Supplement: Vitamin B12
  • Daily oral administration of 50 µg of Vitamin B12

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: A
• No Intervention: B

Primary Measures

• Changes in maternal serum B12 concentration from 1st to 3rd trimester
  • Safety Issue?: No

Secondary Measures

• Changes in maternal hemoglobin levels, maternal weight gain and infant birth-weight.
  • Safety Issue?: No

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.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Harvard School of Public Health

Overall Clinical Trial Officials and Contacts

Christopher P Duggan, MD, MPH Principal Investigator Harvard School of Public Health  

Overall Contact: Sumithra Muthayya, PhD 00-91-2206-5059 sumithra@iphcr.res.in

Information obtained from ClinicalTrials.gov on August 29, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00641862

Study ID Number: HD052143

ClinicalTrials.gov Identifier: NCT00641862

Health Authority: United States: Institutional Review Board