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Benefits and risks of Iron interventions in children (BRISC): protocol for a three-arm parallel-group randomised
Mohammed Imrul Hasan1, Sheikh Jamal Hossain1, Sabine Braat2
1Maternal and Child Health Division, International Centre for Diarrhoeal Disease Research, Dhaka, Bangladesh.
Insights
This study investigates the impact of iron or multiple micronutrient powders (MMPs) supplementation on child development and health. Findings will inform global anemia prevention strategies for young children.
Area of Science:
- Public Health Nutrition
- Child Development
- Iron Deficiency Anemia
Background:
- Anemia, largely due to iron deficiency, affects millions of young children globally.
- WHO recommends iron or MMPs for children under two, but evidence on developmental benefits and infection risks is limited.
- This study addresses critical knowledge gaps regarding these interventions in rural Bangladesh.
Purpose of the Study:
- To evaluate the impact of iron syrup versus MMPs supplementation compared to placebo on child development.
- To assess effects on growth, infection-related morbidity, and iron status in young children.
- To provide evidence for optimizing global anemia control strategies.
Main Methods:
- A three-arm, double-dummy, placebo-controlled superiority trial randomizing 3300 children aged 8-9 months.
- Interventions included iron syrup, MMPs (each with 12.5 mg elemental iron), or placebos for 3 months.
- Primary outcome: cognitive development (Bayley III); secondary outcomes: motor, language, behavior, growth, hematology, iron status, and infectious morbidity.
Main Results:
- Pre-results: Trial registered and approved by ethics committees.
- Data collection completed at baseline, end of intervention, and 9-month follow-up.
- Full results pending dissemination through publications and policy briefs.
Conclusions:
- Evidence on the developmental impact and safety of iron and MMPs supplementation is crucial for public health policy.
- This trial will offer valuable insights into effective anemia prevention and management in young children.
- Findings will guide evidence-based recommendations for global child health initiatives.
Introduction:
Anaemia is a major global health problem affecting about 43% of preschool children globally and 60% of 6-24-month-old children in rural Bangladesh, half of which is attributed to iron deficiency (ID). Although WHO recommends universal supplementation with iron or home fortification with iron-containing multiple micronutrient powders (MMPs) to children under 2 years, evidence for benefits of these interventions on childhood development (a key rationale for these interventions) and harms (especially infection) remains limited. This study aims to evaluate the impact of iron or MMPs supplementation compared with placebo on (a) children's development, (b) growth, (c) morbidity from infections and (d) haematological and iron indices.
Methods And Analysis:
This study is a three-arm, blinded, double-dummy, parallel-group, placebo-controlled superiority trial using stratified individual block randomisation. The trial will randomise 3300 children aged 8-9 months equally to arm 1: iron syrup (12.5 mg elemental iron), placebo MMPs; arm 2: MMPs (including 12.5 mg elemental iron), placebo syrup; and arm 3: placebo syrup, placebo MNPs. Children will receive interventions for 3 months based on WHO recommendations and then be followed up for 9 months post intervention. The primary outcome is cognitive composite score measured by Bayley III. Secondary outcomes include motor and language composite score by Bayley III, behaviour rating using selected items from Wolke's rating scales and BSID-II behaviour ratings, temperament, growth, haemoglobin, anaemia and iron status, and infectious morbidity. Outcomes will be measured at baseline, at the end of 3-month intervention and after 9 months postintervention follow-up.
Ethics And Dissemination:
The trial has been approved by the Ethical Review Committee of icddr,b (Dhaka, Bangladesh) and the Melbourne Health Human Research Ethics Committee (Melbourne, Australia). Results of the study will be disseminated through scientific publications, presentations at international meetings and policy briefs to key stakeholders.
Trial Registration Number:
ACTRN12617000660381;Pre-results.
Who Universal Trial Number:
U1111-1196-1125.
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