A study to evaluate the utility of Vitamin B-12 supplementation of pregnant women in improving the brain development of their infants
Phase 3
Completed
- Registration Number
- CTRI/2018/07/015048
- Lead Sponsor
- Department of Biotechnology
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 708
Inclusion Criteria
Pregnant women
<12 weeks gestation
Vegetarian mothers
Exclusion Criteria
Elderly primi mother ( >35 years)
1. Mothers already on B12 supplementation
2. Women with multiple gestation, those diagnosed with chronic medical conditions (diabetes mellitus, hypertension, heart disease, neurological disease or thyroid disease), and those who tested
positive for hepatitis B, HIV or syphilis (associated with prematurity, IUGR and other neonatal morbidities which could influence neurodevelopment)
1. Women who anticipate moving out of the city before/ after delivery 2. Women treated for infertility
3. Women with known psychological illnesses including depression
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method eurodevelopment scores at 9 month age of infantsTimepoint: May 2020 to June 2021
- Secondary Outcome Measures
Name Time Method Biochemical B12 status of mother and babyTimepoint: June 2021