Status:
COMPLETED
Randomized Trial of Vitamin B12 in Pregnant Indian Women
Lead Sponsor:
Harvard School of Public Health (HSPH)
Collaborating Sponsors:
St. John's Research Institute
Conditions:
Pregnancy
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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 f...
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 fac...
Eligibility Criteria
Inclusion
- Pregnant women at or before 14 weeks gestational age.
Exclusion
- 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.
Key Trial Info
Start Date :
December 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2011
Estimated Enrollment :
366 Patients enrolled
Trial Details
Trial ID
NCT00641862
Start Date
December 1 2008
End Date
January 1 2011
Last Update
July 28 2020
Active Locations (1)
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1
St. John's Medical Research Institute, St. John's National Academy of Health Sciences
Bangalore, Karnataka, India, 560-034