Training and Research Unit of Excellence (TRUE), Blantyre, Malawi
The Micronutrient Forum, Healthy Mothers Healthy Babies Consortium, Washington DC, Washington, USA.
BMJ Open. 2023 Oct 13;13(10):e069011. doi: 10.1136/bmjopen-2022-069011.
Approximately 40% of children aged 6-59 months worldwide are anaemic. Iron-containing multiple micronutrient powders (MNPs) and iron supplements (syrup/drops) are used to combat anaemia in children in different parts of the world. However, evidence for functional benefits of iron supplementation in children is scarce, and potential risks remain poorly defined, particularly concerning diarrhoea and malaria. This trial aims to determine if: (1) the efficacy of iron supplements or MNPs (containing iron) given with malaria chemoprevention is superior to malaria chemoprevention alone, or (2) if the efficacy of malaria chemoprevention alone is superior to placebo on child cognitive development.
IRMA is a four-arm, parallel-group, double-blinded, placebo-controlled, triple-dummy, randomised trial in Southern Malawi. The study recruits 2168 infants aged 6 months, with an intervention period of 6 months and a post-intervention period of a further 6 months. Children are randomised into four arms: (1) No intervention (placebo); (2) malaria chemoprevention only; (3) MNPs and malaria chemoprevention; and (4) iron syrup and malaria chemoprevention. The primary outcome, cognitive development (Cognitive Composite Score (CogCS)), is measured at the end of the 6 months intervention. Secondary outcomes include CogCS at a further 6 months post-intervention, motor, language and behavioural development, physical growth and prevalence of anaemia and iron deficiency. Safety outcomes include incidence of malaria and other infections, and prevalence of malaria parasitaemia during and post-intervention period.
The trial is approved by the National Health Sciences Research Committee (#19/01/2213) (Malawi) and the Human Research Ethics Committee (WEHI: 19/012) (Australia). Written informed consent in the local language is obtained from each participant before conducting any study-related procedure. Results will be shared with the local community and internationally with academic and policy stakeholders.
ACTRN12620000386932.
全球约有 40%的 6-59 月龄儿童贫血。在世界不同地区，使用含铁的多种微量营养素粉末（MNP）和铁补充剂（糖浆/滴剂）来治疗儿童贫血。然而，铁补充对儿童的功能益处的证据很少，潜在风险也定义不清，特别是关于腹泻和疟疾。本试验旨在确定：（1）铁补充剂或含有铁的 MNP 与疟疾化学预防联合使用的疗效是否优于单独的疟疾化学预防，或（2）疟疾化学预防单独使用的疗效是否优于安慰剂对儿童认知发育的影响。
IRMA 是在马拉维南部进行的一项四项、平行组、双盲、安慰剂对照、三盲、随机试验。该研究招募了 2168 名 6 月龄婴儿，干预期为 6 个月，干预后 6 个月。儿童被随机分为四组：（1）无干预（安慰剂）；（2）仅疟疾化学预防；（3）MNP 和疟疾化学预防；（4）铁糖浆和疟疾化学预防。主要结局是认知发育（认知综合评分（CogCS）），在 6 个月干预结束时测量。次要结局包括干预后 6 个月的 CogCS、运动、语言和行为发育、身体生长以及贫血和缺铁的患病率。安全性结局包括疟疾和其他感染的发生率，以及干预和干预后期间疟疾寄生虫血症的患病率。
该试验得到了国家健康科学研究委员会（#19/01/2213）（马拉维）和人类研究伦理委员会（WEHI：19/012）（澳大利亚）的批准。在进行任何研究相关程序之前，都以当地语言从每位参与者那里获得书面知情同意。结果将与当地社区和国际学术界和政策利益相关者分享。
ACTRN12620000386932。
