Chandyo Ram K, Ulak Manjeswori, Kvestad Ingrid, Shrestha Merina, Ranjitkar Suman, Basnet Sudha, Hysing Mari, Shrestha Laxman, Strand Tor A
Centre for Intervention Science in Maternal and Child Health, Centre for International Health, University of Bergen, Bergen, Norway.
Department of Community Medicine, Kathmandu Medical College, Sinamangal, Nepal.
BMJ Open. 2017 Aug 29;7(8):e016434. doi: 10.1136/bmjopen-2017-016434.
Vitamin B is crucial for normal cell division and differentiation, and necessary for the development and myelination of the central nervous system. Pregnant mothers in resource poor settings are at risk for poor vitamin B status. Poor vitamin B status in infancy is linked to poor growth and neurodevelopment. Brain development starts from conception, and pregnancy is a period of rapid growth and development for the brain.
The study is an individually randomised double-blind placebo controlled trial in 800 pregnant Nepalese women randomised in a 1:1 ratio. A daily dose of 50 µg of vitamin B or placebo is given to women from early pregnancy, not later than week 15, until 6 months after birth. Weekly visits are conducted in order to record compliance, growth and morbidity. The primary outcomes are scores on the cognitive, language and motor subscales of the Bayley Scales of Infant and Toddler Development, Third Edition, measured at 6 and 12 months of age, and growth (length and weight) measured at 6 and 12 months of age.
National Health and Research Council, Nepal (NHRC 253/2016) and Regional Committee for Medical and Health Research Ethics of Western Norway (2016/1620/REK vest) have approved the study. Investigators who have contributed to the conceptualising, conducting, as well as being involved in the data analyses and manuscript writing will be eligible for authorship and be responsible to share outcomes with different stakeholders through publications and workshops. The results from this study may support new dietary guidelines for Nepalese and possibly South Asian pregnant women that can lead to improved pregnancy outcomes, neurodevelopment and cognitive functioning in children.
Universal Trial Number: U1111-1183-4093.
clinicaltrials.gov: NCT03071666. Protocol date: version 1.2, 1 June 2017.
维生素B对正常细胞分裂和分化至关重要，对中枢神经系统的发育和髓鞘形成必不可少。资源匮乏地区的孕妇维生素B状态不佳的风险较高。婴儿期维生素B状态不佳与生长发育不良及神经发育有关。大脑发育始于受孕，孕期是大脑快速生长发育的时期。
该研究是一项针对800名尼泊尔孕妇的个体随机双盲安慰剂对照试验，按1:1比例随机分组。从孕早期（不晚于第15周）开始直至产后6个月，每天给孕妇服用50微克维生素B或安慰剂。每周进行访视以记录依从性、生长情况和发病率。主要结局指标为在婴儿和幼儿发展贝利量表第三版的认知、语言和运动子量表上的得分，分别在6个月和12个月时测量，以及在6个月和12个月时测量的生长指标（身长和体重）。
尼泊尔国家卫生与研究委员会（NHRC 253/2016）和挪威西部医学与健康研究伦理区域委员会（2016/1620/REK vest）已批准该研究。对研究的概念化、实施以及参与数据分析和撰写稿件有贡献的研究人员将有资格成为作者，并负责通过出版物和研讨会与不同利益相关者分享研究结果。本研究结果可能支持针对尼泊尔及可能还有南亚孕妇的新饮食指南，从而改善妊娠结局、儿童神经发育和认知功能。
通用试验编号：U1111 - 1183 - 4093。
clinicaltrials.gov：NCT03071666。方案日期：版本1.2，2017年6月1日。
