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Sponsors and Collaborators: |
Harvard School of Public Health St. John's Medical Research Institute |
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Information provided by: | Harvard School of Public Health |
ClinicalTrials.gov Identifier: | NCT00641862 |
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.
Condition | Intervention | Phase |
---|---|---|
Pregnancy Maternal Nutritional Status |
Dietary Supplement: Vitamin B12 |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Efficacy Study |
Official Title: | Randomized Trial of Vitamin B12 in Pregnant Indian Women |
Estimated Enrollment: | 300 |
Study Start Date: | May 2008 |
Arms | Assigned Interventions |
---|---|
A: Experimental |
Dietary Supplement: Vitamin B12
Daily oral administration of 50 µg of Vitamin B12
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B: No Intervention |
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Sumithra Muthayya, PhD | 00-91-2206-5059 ext 134 | sumithra@iphcr.res.in |
Contact: Anura Kurpad, MBBS, Phd | 00-91-2206-5059 ext 101 | a.kurpad@iphcr.res.in |
India, Karnataka | |
St. John's Medical Research Institute, St. John's National Academy of Health Sciences | |
Bangalore, Karnataka, India, 560-034 |
Principal Investigator: | Christopher P Duggan, MD, MPH | Harvard School of Public Health |
Responsible Party: | Children's Hospital Boston ( Christopher P. Duggan ) |
Study ID Numbers: | HD052143 |
Study First Received: | March 17, 2008 |
Last Updated: | March 21, 2008 |
ClinicalTrials.gov Identifier: | NCT00641862 |
Health Authority: | United States: Institutional Review Board; India: Institutional Review Board |
Pregnancy Maternal Nutritional Status Vitamin B12 |
Hydroxocobalamin Vitamin B 12 |
Vitamin B Complex Hematinics Therapeutic Uses Growth Substances Vitamins |
Hematologic Agents Physiological Effects of Drugs Micronutrients Pharmacologic Actions |