Supplementation of vitamin B12 in young men and women, pre-conception, improves the B12 status of their newborns
- Conditions
- utrition and developmental origins of health and diseaseNutritional, Metabolic, Endocrine
- Registration Number
- ISRCTN32921044
- Lead Sponsor
- King Edward Memorial Hospital Research Centre (India)
- Brief Summary
2017 Protocol article in https://pubmed.ncbi.nlm.nih.gov/32153821/ protocol (added 15/10/2020) 2021 Preprint results in https://www.medrxiv.org/content/10.1101/2021.09.09.21263316v1?ct= non-peer-reviewed results (added 21/09/2021)
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 557
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
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method mbilical cord blood measurement of vitamin B12 concentration
- Secondary Outcome Measures
Name Time Method Birth weight and neonatal body composition (by anthropometric measurements)