Efficacy of maternal B12 supplementation in vegetarian women for improving infant neurodevelopment: protocol for the MATCOBIND multicentre, double-blind, randomised controlled trial.
Efficacy of maternal B12 supplementation in vegetarian women for improving infant neurodevelopment: protocol for the MATCOBIND multicentre, double-blind, randomised controlled trial.
复制标题
素食女性补充 B12 对改善婴儿神经发育的功效：MATCOBIND 多中心、双盲、随机对照试验方案。
DOI：
10.1136/bmjopen-2019-034987
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发表时间：
2020
期刊：
影响因子：
2.9
通讯作者：
Nagpal J
中科院分区：
文献类型：
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作者：
Nagpal J
维生素B12缺乏症在许多低收入和中等收入国家普遍存在，特别是在动物来源较少的饮食中。虽然许多观察性研究表明，在怀孕和婴儿认知功能（包括记忆，语言和运动技能）的B12缺乏症之间的关联，从临床试验的证据是稀疏和inconclusive.Methods和analysisThis双盲，多中心，随机对照试验将招收720素食孕妇在他们的头三个月从产前诊所在两家医院（一个在印度和尼泊尔）。给予书面同意的合格母亲将随机接受250 mcg甲钴胺或50 mcg（准对照），从入组至产后6个月，每日口服胶囊。所有母亲及其婴儿将继续接受标准临床护理。主要的试验结果是后代在9个月大时的神经发育状况，使用印度婴儿发育评估量表进行评估。次要结果包括婴儿在9个月大时的生化B12状态和母亲在第一和第三孕期的生化B12状态。还将在孕早期评估母体生物化学B12状态。修改协会的先验确定的因素也将explored.Ethical考虑和disseminationThe研究方案已批准的伦理委员会在每个研究地点（印度和尼泊尔）和英国伦敦大学学院。研究结果将通过会议、演讲和出版物传播给全球的医疗保健专业人员和学者。每个研究中心的研究人员将在随访期间与参与者分享结果。试验注册编号CTRI/2018/07/015048（印度临床试验注册中心）; NCT 04083560（ClinicalTrials.gov）
IntroductionVitamin B12deficiency is widely prevalent across many low- and middle-income countries, especially where the diet is low in animal sources. While many observational studies show associations between B12deficiency in pregnancy and infant cognitive function (including memory, language and motor skills), evidence from clinical trials is sparse and inconclusive.Methods and analysisThis double-blind, multicentre, randomised controlled trial will enrol 720 vegetarian pregnant women in their first trimester from antenatal clinics at two hospitals (one in India and one in Nepal). Eligible mothers who give written consent will be randomised to receive either 250 mcg methylcobalamin or 50 mcg (quasi control), from enrolment to 6 months post-partum, given as an oral daily capsule. All mothers and their infants will continue to receive standard clinical care. The primary trial outcome is the offspring’s neurodevelopment status at 9 months of age, assessed using the Development Assessment Scale of Indian Infants. Secondary outcomes include the infant’s biochemical B12status at age 9 months and maternal biochemical B12status in the first and third trimesters. Maternal biochemical B12status will also be assessed in the first trimester. Modification of association by a priori identified factors will also be explored.Ethical considerations and disseminationThe 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)