Division of Mental Health and Neurosciences, St. John's Research Institute, Bangalore, Karnataka, India.
Department of Biostatistics, St John's Medical College, Bangalore, Karnataka, India.
BMJ Open. 2019 Feb 19;9(2):e024426. doi: 10.1136/bmjopen-2018-024426.
Vitamin B12 deficiency is highly prevalent in pregnant Indian women. Neuropsychological tests have shown an association between low maternal vitamin B12 status and poorer cognitive performances in the offspring, although findings from these studies have been inconsistent. Vitamin B12 has an important role in the formation of myelin which is important for the transmission speed of neural impulses and myelination in the central nervous system has been linked to cognition. Assessing neurophysiological measures using event-related potentials (ERPs) in children may provide additional information on the effect of maternal vitamin B12 supplementation on offspring brain function. The study examines the effects of oral vitamin B12 daily supplements (50 µg) to pregnant Indian women on child neurophysiological function at 72 months.
We previously conducted a double-blind, placebo-controlled study to examine the effects of maternal vitamin B12 supplementation on cognitive outcomes in their offspring using the Bayley scales of infant development, third edition. In this extended follow-up of the same cohort of mother-child dyad, we propose to use ERP to study the long-term impact of maternal B12 supplementation on brain function in children at 72 months of age. We intend to use P300 and mismatch negativity (MMN) as measures of neurophysiological outcomes. The primary outcome of this study will be child neurophysiological measures (as measured by amplitude and latency of P300 and MMN) assessed at 72 months of age in children whose mothers received vitamin B12 compared with neurophysiological status of children whose mothers received placebo.
The study was approved by the Institutional Ethical Board of St. John's Medical College and the Harvard School of Public Health Human Subjects Committee. Results obtained will be presented at national and international research meetings and published in peer-reviewed scientific journals.
NCT00641862.
维生素 B12 缺乏在印度孕妇中极为普遍。神经心理学测试表明，母体维生素 B12 水平低与后代认知表现较差之间存在关联，尽管这些研究的结果并不一致。维生素 B12 在髓鞘的形成中起着重要作用，髓鞘对于神经冲动的传递速度很重要，而中枢神经系统的髓鞘形成与认知有关。使用事件相关电位 (ERP) 评估儿童的神经生理测量值可能会提供有关母体维生素 B12 补充对后代大脑功能影响的额外信息。该研究探讨了每日口服 50μg 维生素 B12 补充剂对 72 个月大儿童神经生理功能的影响。
我们之前进行了一项双盲、安慰剂对照研究，使用贝利婴幼儿发育量表第三版评估母体维生素 B12 补充对后代认知结果的影响。在同一母婴对子队列的这项扩展随访中，我们提议使用 ERP 研究母体 B12 补充对 72 个月大儿童大脑功能的长期影响。我们打算使用 P300 和失匹配负波 (MMN) 作为神经生理结果的衡量标准。该研究的主要结果将是接受维生素 B12 的母亲所生儿童与接受安慰剂的母亲所生儿童的儿童神经生理测量值（通过 P300 和 MMN 的振幅和潜伏期来衡量），评估时间为 72 个月。
该研究得到了圣约翰医学院机构伦理委员会和哈佛公共卫生学院人类受试者委员会的批准。将在国家和国际研究会议上介绍研究结果，并在同行评议的科学期刊上发表。
NCT00641862。
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