A randomised controlled trial to compare two different doses of maternal B12 supplementation in improving infant B12 deficiency and neurodevelopment

一项随机对照试验，比较两种不同剂量的母亲维生素 B12 补充剂在改善婴儿维生素 B12 缺乏和神经发育方面的作用

• 批准号: MR/R020396/1
• 负责人: Monica Lakhanpaul
• 金额: $ 50.64万
• 依托单位: University College London
• 依托单位国家: 英国
• 项目类别: Research Grant
• 财政年份: 2018
• 资助国家: 英国
• 起止时间: 2018 至 无数据
• 项目状态: 已结题
• 来源: https://gtr.ukri.org/projects?ref=MR%2FR020396%2F1
• 关键词: randomised; controlled; trial; compare; two

Vitamin B12, also called cobalamin, is a water-soluble vitamin that has a key role in the normal functioning of the brain and nervous system. Up to 74% women are reported deficient during antenatal period in some populations. Deficiency of B12 in newborns is problematic given the role Vitamin B12 plays in neuronal health (brain and nerve cells health) and in the development of foetal and infant brain. We propose this research to compare two different doses (a treatment dose in comparison with a dose known to just prevent further deficiency) of maternal Vitamin B12 supplementation in terms of their effectiveness in removing infant B12 deficiency and neurodevelopment.We propose to undertake a multi-centric trial in India and Nepal as these are countries where high incidence of deficiency is reported. We will recruit 720 pregnant women from the antenatal clinics of the department of Gynaecology and Obstetrics at Sitaram Bhartia institute of Science and Research, New Delhi and Paropakar Indrarajayalaxmi Maternity Hospital, Kathmandu, Nepal. The subjects will be recruited at their first presentation to the antenatal clinic and should be vegetarian as they are at high-risk of B12 deficiency. Mothers who are >35 years of age, are already on B12 supplementation, have multiple gestation, chronic medical conditions, known psychological illnesses or those who anticipate moving out of the city before/after delivery will be excluded from the study. Recruited mothers will be randomly allocated to 2 equal groups (360 each). Group 1 (Intervention) will receive daily 250 micrograms Vitamin B12 supplementation to the mother through pregnancy and up to 6 months post-partum. Group 2 (Control) will receive 50 micrograms Vitamin B12 supplementation to the mother through pregnancy and up to 6 months post-partum. The profile information of the mother including age, height, weight, ethnicity, education, socioeconomic status, maternal dietary assessment (by Food Frequency Questionnaire), intake of any supplements (iron, folate, Vitamin-D) etc. will be recorded. Vitamin B12 dosage will be provided at enrolment and then monthly to mothers. Mother's blood levels for Vitamin B12 status and other deficiencies will be drawn. Sampling for these biochemical tests will be combined with other routine tests at these stages to avoid any additional discomfort for the mother. At childbirth, the delivery and post-delivery course of the new-born will be monitored and documented for any problems potentially influencing neurodevelopment. After discharge, all neonates will be routinely followed with preventive and vaccination care as per standard protocols. During routine visits, anthropometric measurements including weight, length and head circumference will be recorded and signs of micronutrient deficiency (especially anaemia and rickets) will be noted. Any illnesses suffered by the child in the intervening period will be recorded. Supplementation of the mother in both groups will be stopped at 6 months after childbirth followed by evaluation at 9 months. The neurodevelopmental assessment and home environment assessment will be done by a developmental therapist and complementary feeding assessment by a nutritionist. Along with routine sampling for Hb screening at 9 months, infant B12 levels status will be determined. The assessment of the infant neurodevelopment scores, the biochemical measures of B12 status of the infant and those of the mother will then be compared between the two groups to see if the neurodevelopment and/or B12 status in the group receiving the higher dose (250 mcg) is better and safe. A positive or a negative result will generate scientific evidence on whether B12 should be supplemented in vegetarian pregnant women with a view to preventing B12 deficiency and its neurodevelopmental consequences in the infant. This will also allow the development of policies and frameworks for routine/wider usage of this supplement in high-risk populations

维生素B12，也称为钴胺素，是一种水溶性维生素，在大脑和神经系统的正常功能中具有关键作用。据报道，在某些人群中，在产前期间，多达74％的妇女缺乏。鉴于维生素B12在神经元健康（脑和神经细胞健康）以及胎儿和婴儿脑的发展中的作用，新生儿中B12的缺乏是有问题的。我们建议这项研究比较母体维生素B12在消除婴儿B12缺乏症和神经发育方面的有效性方面的两种不同剂量（与已知可以防止进一步缺乏的剂量相比）的治疗剂量。我们将在新德里和尼泊尔加德满都的妇科和妇产科科学与研究所的妇科和妇产科科学与研究所的妇产科和妇产科诊所招募720名孕妇。这些受试者将在首次介绍到产前诊所的首次介绍中招募，应该是素食主义者，因为他们处于B12缺乏症的高风险。 > 35岁的母亲已经接受了B12的补充，患有多种妊娠，慢性医疗状况，已知的心理疾病，或者预计将在分娩前/之后搬出城市的母亲将被排除在研究之外。招募的母亲将随机分配给2个平等组（每组360个）。第1组（干预）将每天接受250微克维生素B12的维生素B12，以通过妊娠和产后6个月的时间补充母亲。第2组（对照）将通过怀孕和产后6个月的母亲接受50微克维生素B12的补充。母亲的概况信息包括年龄，身高，体重，种族，教育，社会经济状况，孕产妇饮食评估（通过食品频率问卷），任何补充剂的摄入量（铁，叶酸，维生素-D）等。维生素B12剂量将在入学时提供，然后每月向母亲提供。将征收母亲的维生素B12状态和其他缺陷的血液水平。这些生化测试的采样将与这些阶段的其他常规测试相结合，以避免母亲的其他不适。在分娩时，新生儿的分娩和交付后课程将受到监测和记录，以解决可能影响神经发育的任何问题。出院后，按照标准方案，将常规遵循预防和疫苗接种护理。在常规访问期间，将记录包括体重，长度和头圆周在内的人体测量值，并注意到微量营养素缺乏症（尤其是贫血和腐烂）的迹象。在此期间，孩子遭受的任何疾病将记录。两组中母亲的补充将在分娩后6个月停止，然后在9个月时进行评估。神经发育评估和家庭环境评估将由营养学家的发展治疗师和补充喂养评估进行。除了在9个月时进行HB筛查的常规采样外，婴儿B12水平状态还将确定。然后，将在两组之间对婴儿神经发育评分，婴儿和母亲的B12状态的生化度量进行评估，以查看接受较高剂量（250 mcg）的组中的神经发育和/或B12状态是否更好并且安全。积极或负面的结果将产生科学证据，表明是否应在素食孕妇中补充B12，以防止B12缺乏症及其在婴儿中的神经发育后果。这还将允许制定政策和框架以常规/更广泛的使用中的高风险人群使用

项目成果

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

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
• 发表时间: 2020
• 期刊: BMJ open
• 影响因子: 2.9
• 作者: Nagpal J

327 Maternal B-12 supplementation in vegetarian pregnant women improves maternal B-12 status and infant neurodevelopment: The MATCOBIND multi-centric double-blind randomised-control-trial

327 素食孕妇补充 B-12 可改善母亲 B-12 状态和婴儿神经发育：MATCOBIND 多中心双盲随机对照试验

• DOI: 10.1136/archdischild-2023-rcpch.486
• 发表时间: 2023
• 作者: Nagpal J