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BRISC

Benefits and Risks of Iron InterventionS in Children: a randomized controlled trial in rural Bangladesh

 

The problem

Worldwide, nearly half of all children under the age of 5 years have anaemia. In Bangladesh, 60 per cent of 6–24-month-old children are affected by anaemia, half of which are attributed to iron deficiency.

The World Health Organization currently recommends universal distribution of iron supplements or multiple micronutrient powders (MNPs) that include iron to children aged 6-23 months in settings where anaemia is prevalent. However, little has been known about the safety and effects of these iron supplementations on children’s developmental outcomes.

The trial

This research project aimed to evaluate the impact of iron or MNPs supplementation on child cognitive function, behaviour and development in young children in Bangladesh.

A three-arm randomized controlled was conducted in rural Bangladesh, where 3300 8-month-old children were randomly assigned to receive either iron drops, home-fortification of food with MNPs, or placebo as part of a daily regimen for three months. The primary objective was to evaluate the impact of iron supplementation and MNPs on cognitive development in young children, compared with a placebo. The outcomes of this trial were published in the New England Journal of Medicine in 2021 (Pasricha NEJM 2021).

Since the conclusion of the BRISC project in 2020, an extension study has been approved. Although the main study did not find any effects of iron or MNPs on developmental outcomes, the extension study provides an opportunity to assess if effects of iron interventions on children’s development can be observed later. The aim of the extension study is to measure the long-term effects of early life iron supplementation at pre-school age, school age and ultimately, adolescence.

This study also will measure the effects of COVID-19 on families’ incomes, food insecurity and the mental health of mothers. A study undertaken early in the pandemic demonstrated the devastating impact of lockdowns and the pandemic on income, food security and mental health in Bangladeshi women (Hamadani et al Lancet Global Health 2020). The extension study is ongoing: a follow up study on the impact of the pandemic on income, food security and mental health has just been completed, and a further analysis on child development is planned for late 2022 as children enter preparatory school.

Diagram of trial processes

The team

Resources

Global maternal and child health trials in Africa and Asia
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