Global maternal and child health trials in Asia and Africa

• Our trials: Improving maternal and child health

• REVAMP-TT - Randomized controlled trial of the Effect of intraVenous iron on Anaemia in Malawian Pregnant women in the Third Trimester  

• EDIVA - Efficacy and Demonstration of IntraVenous Iron for Anaemia in Pregnancy

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

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.

The team

Dr Jena Hamadani, Principal Investigator, Maternal and Child Health Division, International Centre for Diarrhoeal Disease Research, Bangladesh

Professor Beverly-Ann Biggs, Co-Principal Investigator, Department of Medicine at the Doherty Institute, University of Melbourne

Dr Shams El Arifeen, Co-Principal Investigator, Maternal and Child Health Division, International Centre for Diarrhoeal Disease Research, Bangladesh

Professor Sant-Rayn Pasricha, Co-Investigator, Population Health and Immunity Division, WEHI

Dr Imrul Mohammed Hasan, Trial Manager, Maternal and Child Health Division, International Centre for Diarrhoeal Disease Research, Bangladesh

Sabine Braat, Senior Biostatistician, Population Health and Immunity Division, WEHI

Andrew Baldi, PhD Candidate, Population Health and Immunity Division, WEHI

Dr Leila Larson, Trial Manager, Arnold School of Public Health, University of South Carolina

Beth Hilton-Thorp, Trial Administrator, University of Melbourne

Shamima Shiraji, Co-Investigator, International Centre for Diarrhoeal Disease Research, Bangladesh

Dr Saiful Alam Bhuiyan, Co-Investigator, International Centre for Diarrhoeal Disease Research, Bangladesh

Eliza Davidson, Co-Investigator, Population Health and Immunity Division, WEHI

Sheikh Jamal Hossain, Co-Investigator, International Centre for Diarrhoeal Disease Research, Bangladesh

Associate Professor Stefan Bode, Cognitive Neuroscientist, The University of Melbourne

Associate Professor Katherine Johnson, Developmental Cognitive Neuroscientist, The University of Melbourne

Dr Daniel Feuerriegel, Cognitive Neuroscientist, The University of Melbourne

Partnerships/collaborators

• The International Centre for Diarrheal Disease Research, Dhaka (icddr,b), Bangladesh
• The University of Melbourne, Australia

Funders

• The Australian National Health and Medical Research Council

More information

• Trials registry: ANZCTR registration
• Contact: pasricha.s@wehi.edu.au

Key publications

• Pasricha SR, Hasan MI, Braat S, Larson LM, Tipu SMMU, Hossain SJ, Shiraji S, Baldi A, Bhuiyan MSA, Tofail F, Fisher J, Grantham-McGregor S, Simpson JA, Hamadani JD, Biggs BA. Benefits and Risks of Universal Iron Interventions in Infants. New Engl J Med. 2021. Sep 9;385(11):982-995. doi: 10.1056/NEJMoa2034187.
• Hamadani JD, Hasan MI, Baldi AJ, Hossain SJ, Shiraji S, Bhuiyan MSA, Mehrin SF, Fisher J, Tofail F, Tipu SMMU, Grantham-McGregor S, Biggs BA, Braat S, Pasricha SR. Immediate impact of stay-at-home orders to control COVID-19 transmission on socioeconomic conditions, food insecurity, mental health and intimate partner violence in Bangladeshi women and their families: an interrupted time-series. Lancet Glob Health. 2020. doi: 10.1016/ S2214-109X(20)30366-1 | Read article
• Larson L, Feuerriegel D, Hasan MI, et al. Effects of Supplementation With Iron Syrup or Iron-Containing Multiple Micronutrient Powders on Neural Indices of Cognitive Functioning in Bangladeshi Children. Current Developments in Nutrition 2021; 5(Supplement_2): 656-.
• Braat, S., Larson, L., Simpson, J. A., Hasan, M. I., Hamadani, J. D., Hossain, S. J., Shiraji, S., Bhuiyan, M. S. A., Biggs, B. -A. & Pasricha, S. -R. (2020). The Benefits and Risks of Iron interventionS in Children (BRISC) trial: Statistical analysis plan. F1000Research, 9, pp.427-427. https://doi.org/10.12688/f1000research.23383.1. | Read article
• Hasan MI, Hossain SJ, Braat S, et al. Benefits and risks of Iron interventions in children (BRISC): protocol for a three-arm parallel-group randomised controlled field trial in Bangladesh. BMJ Open 2017; 7(11): e018325 | Read article