Vitamin B12 and protein supplementation in adolescents and its effect in next generation: Pune Intervention Study
- Registration Number
- CTRI/2012/12/003212
- Lead Sponsor
- Indian Council of Medical Research
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 700
Adolescents in the Pune Maternal Nutrition Study, who agree to participate (assent), and whose parent/s give informed, written consent
1. Plasma vitamin B12 concentration <100pmol/L
2. Hemoglobin concentration <7g/dL
3. Severe developmental disability likely to interfere with marriage and reproduction
4. Serious systemic illness (that would prohibit participation in any clinical trial, e.g. malignancy, reproductive system disorder leading to infertility, congenital or acquired cardiovascular disease with NYHA Functional Classification III or IV)
5. Treatment with drugs interfering with one-carbon metabolism (e.g. folate antagonists: phenytoin, valproic acid, carbamazepine, trimethoprim, methotrexate; B12 antagonists: metformin, PPIs)
6. Treatment with hematinics (iron and/ or B group of vitamins) for more than 30 days
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Cord blood vitamin B12 concentrations in pmol/LTimepoint: One, at delivery; Cord blood vitamin B12 concentrations in pmol/
- Secondary Outcome Measures
Name Time Method Birth weight and neonatal body compositionTimepoint: 1, birth weight and skin-fold thicknesses