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Efficacy of maternal B12 supplementation in vegetarian women for improving infant neurodevelopment: protocol for the MATCOBIND multicentre, double-blind, randomised controlled trial.

Jitender NagpalManu Raj MathurSwapnil RawatDeepti NagrathCharlotte L LeeAtul SinghalMichelle HeysMario Cortina BorjaKatrin AugustinJageshwor GautamRajendra PantLaura S NixonMonica Lakhanpaul
Published in: BMJ open (2020)
The study protocol has been approved by ethical committees at each study site (India and Nepal) and at University College London, UK. The study results will be disseminated to healthcare professionals and academics globally via conferences, presentations and publications. Researchers at each study site will share results with participants during their follow-up visits.Trial registration numberCTRI/2018/07/015048 (Clinical Trial Registry of India); NCT04083560 (ClinicalTrials.gov).
Keyphrases
  • study protocol
  • clinical trial
  • randomized controlled trial
  • double blind
  • phase iii
  • open label
  • phase ii
  • polycystic ovary syndrome
  • pregnant women
  • metabolic syndrome
  • adipose tissue
  • decision making