Maternal vitamin B12, folate and homocysteine as determinants of inter-generational programming of diabesity: the Pune Intervention Study

King Edward Memorial Hospital Research Centre (India)0 个研究点目标入组 557 人开始时间: 2012年11月1日最近更新: 2021年10月4日

适应症

试验速览

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)

•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

发起方

King Edward Memorial Hospital Research Centre (India)