Enhancing brain development by early iron supplementation of African infants: An enabling pilot study

通过非洲婴儿早期补铁促进大脑发育：一项有利的试点研究

• 批准号: MR/T003960/1
• 负责人: Carla Cerami
• 金额: $ 25.61万
• 依托单位: London School of Hygiene & Tropical Medicine
• 依托单位国家: 英国
• 项目类别: Research Grant
• 财政年份: 2021
• 资助国家: 英国
• 起止时间: 2021 至 无数据
• 项目状态: 已结题
• 来源: https://gtr.ukri.org/projects?ref=MR%2FT003960%2F1
• 关键词: Enhancing; brain; development; early; iron

Iron is crucial for brain development and early deficiencies during infancy can cause irreparable damage. Figures from the latest Global Burden of Disease analysis estimate that iron deficiency is more common than all other micronutrient deficiencies combined. This burden is concentrated in sub-Saharan Africa and South Asia. Breast milk contains very little iron, so babies draw upon iron stores laid down in their liver during late foetal life. However, the babies of iron deficient mothers are born with a limited endowment of iron and can rapidly develop iron deficiency. We have recently shown that, by 5 months of age, almost 95% of rural Gambian infants have circulating iron levels below the lower limit of the US reference range. This indicates that these babies are profoundly iron deficienct. The American Academy of Pediatrics (AAP) recommends iron supplementation in exclusively breastfed infants beginning at 4 months of age. AAP also recommends that babies born prematurely start supplementation at 2 weeks. Yet prior and on-going trials of iron supplementation in low-income settings have commenced supplementation much later (eg 8-9m in a large on-going trial in Bangladesh). Our data suggest that this will be too late to prevent early iron deficiency from impairing brain development. We therefore propose a large randomised controlled trial of early iron supplementation starting at 6wks of age. In preparation for such a trial we need to conduct preliminary studies addressing the following questions: Can we effectively enhance circulating iron levels in early infancy by giving daily iron drops? Can we achieve this without undermining duration of exclusive breast feeding? Might the iron alter the balance of the babies' gut microbial flora and thereby cause diarrhoea? Might iron supplementation impair the absorption of zinc and copper and hence require a triple supplement?These questions will be tested in a small enabling study that will inform the design of the intended full trial.

铁对大脑发育至关重要，婴儿期的早期缺乏会造成无法弥补的损害。最新的全球疾病负担分析数据估计，缺铁比所有其他微量营养素缺乏症加起来更常见。这一负担集中在撒哈拉以南非洲和南亚。母乳中含有很少的铁，所以婴儿在胎儿晚期会利用肝脏中储存的铁。然而，缺铁母亲的婴儿出生时铁的禀赋有限，并且可以迅速发展为缺铁。我们最近的研究表明，到5个月大时，近95%的冈比亚农村婴儿的循环铁水平低于美国参考范围的下限。这表明这些婴儿严重缺铁。美国儿科学会（AAP）建议纯母乳喂养的婴儿从4个月大开始补充铁。AAP还建议早产儿在2周时开始补充。然而，在低收入环境中进行的先前和正在进行的铁补充试验开始补充的时间要晚得多（例如，在孟加拉国正在进行的一项大型试验中，有8- 900万人）。我们的数据表明，这将是为时已晚，以防止早期缺铁损害大脑发育。因此，我们提出了一个大型的随机对照试验，早期补铁开始在6周龄。在准备这样一个试验，我们需要进行初步研究，解决以下问题：我们可以有效地提高循环铁水平在婴儿早期通过每天铁滴？我们能在不影响纯母乳喂养持续时间的情况下实现这一目标吗？铁是否会改变婴儿肠道微生物植物群的平衡，从而导致腹泻？铁补充剂是否会损害锌和铜的吸收，因此需要三重补充？这些问题将在一项小型使能研究中进行测试，该研究将为预期的完整试验设计提供信息。

项目成果

Iron supplementation of breastfed Gambian infants from 6 weeks to 6 months of age: protocol for a randomised controlled trial.

对母乳喂养的冈比亚婴儿的补充6周至6个月大：随机对照试验的方案。

• DOI: 10.12688/wellcomeopenres.17507.1
• 发表时间: 2022
• 期刊: Wellcome open research

Early iron supplementation of exclusively breastfed African infants: a proof-of-principle, placebo-controlled, randomised, double-blinded efficacy trial

纯母乳喂养的非洲婴儿早期补铁：一项原理验证、安慰剂对照、随机、双盲疗效试验

• DOI: 10.1101/2023.01.12.22284059
• 发表时间: 2023
• 作者: Bah M

Haem iron versus ferrous iron salts to treat iron deficiency anaemia in Gambian children: protocol for randomised controlled trial {1}

血红素铁与亚铁盐治疗冈比亚儿童缺铁性贫血：随机对照试验方案{1}

• DOI: 10.21203/rs.3.rs-3688022/v1
• 发表时间: 2024
• 作者: Bah M