CTRI/2018/07/015048
Completed
Phase 3
A randomised controlled trial to compare two different doses of maternal B12 supplementation in improving infant B12 deficiency and neurodevelopment - MATCOBIND
Department of Biotechnology0 sites708 target enrollmentTBD
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Department of Biotechnology
- Enrollment
- 708
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
Not specified
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