Randomized Trial of Vitamin B12 in Pregnant Indian Women

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
St. John's Research Institute
Information provided by (Responsible Party):
Christopher Duggan, Harvard School of Public Health
ClinicalTrials.gov Identifier:
NCT00641862
First received: March 17, 2008
Last updated: October 9, 2013
Last verified: October 2013
  Purpose

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
Dietary Supplement: Vitamin B12
Other: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Randomized Trial of Vitamin B12 in Pregnant Indian Women

Resource links provided by NLM:


Further study details as provided by Harvard School of Public Health:

Primary Outcome Measures:
  • Changes in maternal serum B12 concentration from 1st to 3rd trimester [ Time Frame: from 1st to 3rd trimester ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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. ] [ Designated as safety issue: No ]
  • Childhood neurodevelopment/neurocognitive function [ Time Frame: 18 and 30 months ] [ Designated as safety issue: No ]
    Neurodevelopmental status and neurocognitive function are measured by measured by the cognitive scale of the Bayley scales of infant development, 3rd edition


Enrollment: 366
Study Start Date: December 2008
Estimated Study Completion Date: April 2014
Estimated Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Vitamin B12
Vitamin B12
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
Placebo Comparator: Placebo
Placebo
Other: Placebo
Placebo taken daily from enrollment (at or before 14 weeks gestational age) until delivery

Detailed 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00641862

Locations
India
St. John's Medical Research Institute, St. John's National Academy of Health Sciences
Bangalore, Karnataka, India, 560-034
Sponsors and Collaborators
Harvard School of Public Health
St. John's Research Institute
Investigators
Principal Investigator: Christopher P Duggan, MD, MPH Harvard School of Public Health
Principal Investigator: Anura Kurpad, MBBS, PhD St. John's Research Institute
Principal Investigator: Krishnamachari Srinivasan, MD St. John's Research Institute
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Christopher Duggan, Associate Professor, Department of Nutrition, Harvard School of Public Health
ClinicalTrials.gov Identifier: NCT00641862     History of Changes
Other Study ID Numbers: HD052143
Study First Received: March 17, 2008
Last Updated: October 9, 2013
Health Authority: United States: Institutional Review Board
India: Institutional Review Board

Keywords provided by Harvard School of Public Health:
Pregnancy
Maternal Nutritional Status
Vitamin B12

Additional relevant MeSH terms:
Vitamins
Vitamin B 12
Hydroxocobalamin
Vitamin B Complex
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Hematinics
Hematologic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on September 18, 2014