Stelle Isabella, Bah Mamadou, Silverio Sergio A, Verhoef Hans, Comma Ebrima, Prentice Andrew M, Moore Sophie E, Cerami Carla
Department of Women and Children's Health, King's College London, 10th Floor North Wing, St. Thomas' Hospital, Westminster Bridge Road, London, SE1 7EH, UK.
Nutrition and Planetary Health Theme, MRC Unit The Gambia @ the London School of Hygiene and Tropical Medicine, PO Box 273, Banjul, The Gambia.
Wellcome Open Res. 2022 Jan 18;7:16. doi: 10.12688/wellcomeopenres.17507.1. eCollection 2022.
A recent analysis showed that plasma iron concentrations decline rapidly from birth in Gambian infants, irrespective of sex or birthweight, to concentrations well below normal expected values for iron-replete children older than two months of age (typically >10 μmol/L). The development and function of neural and immune cells may thus be compromised before the minimum age at which children should receive iron supplementation as per World Health Organisation recommendations. This study is a two-arm, double-blind, placebo-controlled, randomised superiority trial. Infants will be randomised to receive iron drops (7.5mg/day of iron as ferrous sulphate) or placebo daily for 98 days, to test the impact on serum iron concentrations in healthy, breastfed infants (n = 100) aged 6-10 weeks at enrolment. Participants will be visited daily and supplemented by the field team. Daily health and weekly breastfeeding questionnaires will be administered. Anthropometry, and venous blood and faecal samples will be collected at enrolment and after 98 days of supplementation with serum iron as the primary endpoint. Low birthweight (less than 2.5kg at birth) and infants born prematurely (< 37 weeks) will not be excluded. Formula-fed and infants with any illness will be excluded. An additional study exploring maternal stakeholder perspectives of the intervention will be conducted by means of maternal interviews and four focus group discussions with local stakeholders. Most breast-fed Gambian infants have very low circulating iron levels by five months of age. This study will introduce iron supplements much earlier in infancy than has previously been attempted in a low-income setting with the primary aim of increasing serum iron concentration. Clincaltrials.gov ( NCT04751994); 12 February 2021.
最近的一项分析表明，冈比亚婴儿出生后血浆铁浓度迅速下降，无论性别或出生体重如何，降至远低于两个月以上铁充足儿童正常预期值（通常>10 μmol/L）的水平。因此，在按照世界卫生组织建议儿童应开始补充铁剂的最低年龄之前，神经和免疫细胞的发育及功能可能会受到损害。本研究是一项双臂、双盲、安慰剂对照的随机优效性试验。婴儿将被随机分为两组，一组每天接受铁滴剂（以硫酸亚铁形式提供7.5毫克/天的铁），另一组每天接受安慰剂，为期98天，以测试对入组时年龄为6至10周的健康母乳喂养婴儿（n = 100）血清铁浓度的影响。研究团队将每天探访参与者并进行补充。将发放每日健康问卷和每周母乳喂养问卷。在入组时以及补充98天后收集人体测量数据、静脉血和粪便样本，以血清铁作为主要终点指标。低出生体重儿（出生时体重不足2.5千克）和早产儿（<37周）将不被排除。人工喂养的婴儿和患有任何疾病的婴儿将被排除。还将通过对母亲进行访谈以及与当地利益相关者进行四次焦点小组讨论，开展一项额外研究，探讨母亲利益相关者对该干预措施的看法。大多数冈比亚母乳喂养婴儿到五个月大时循环铁水平非常低。本研究将在婴儿期比以往在低收入环境中尝试的时间更早地引入铁补充剂，主要目的是提高血清铁浓度。Clinicaltrials.gov（NCT04751994）；2021年2月12日。
