Nutrition and developmental origins of health and disease Nutritional, Metabolic, Endocrine
Conditions
Interventions
The three intervention groups are as follows:
1. Vitamin B12 capsules - 1.0 µg
2. Multiple micronutrients capsules:
Vitamin A - 300 µg
V
Sponsors
King Edward Memorial Hospital Research Centre (India)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Adolescents in the Pune Maternal Nutrition Study (boys and girls) 2. Who are not pregnant 3. Who agree to participate (assent) in the study 4. Whose parent/s give informed written consent
Exclusion criteria
Exclusion criteria: 1. Plasma vitamin B12 concentration <100pmol/L 2. Haemoglobin 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 New York Heart Association (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, Proton-pump inhibitors (PPIs)] 6. Treatment with hematinics (containing B group of vitamins) for more than 30 days
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| Birth weight and neonatal body composition (by anthropometric measurements) | — |
Primary
| Measure | Time frame |
|---|---|
| Umbilical cord blood measurement of vitamin B12 concentration | — |
Countries
India
Outcome results
None listed