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Iron or Multiple Micronutrient Powder Supplements With Malaria Chemoprevention in Rural Malawian Children: The IRMA
Kamija S Phiri1,2, Glory Mzembe1,2, Maclean Vokhiwa1,2
1Training and Research Unit of Excellence, Blantyre, Malawi.
Insights
Universal iron interventions did not improve cognitive development in young children in Malawi. The study found no significant benefits for cognitive outcomes or anemia reduction, with no increased risk of malaria.
Area of Science:
- Pediatric Health
- Nutritional Interventions
- Infectious Disease Epidemiology
Background:
- The World Health Organization recommends iron interventions for children in high-anemia areas to support neurodevelopment.
- However, evidence from randomized clinical trials confirming functional benefits and addressing infection risks is limited.
Purpose of the Study:
- To evaluate if universal iron supplementation, combined with malaria chemoprevention, enhances functional outcomes in young children.
- To assess the safety of these interventions regarding infection risk in a malaria-endemic region.
Main Methods:
- A randomized clinical trial involving 2168 infants (mean age 5.7 months) in southern Malawi.
- Four intervention groups: iron syrup + malaria chemoprevention, iron micronutrient powders + malaria chemoprevention, malaria chemoprevention alone, or placebo alone.
- Cognitive, language, and motor development assessed using Bayley Scales of Infant and Toddler Development-Third Edition (Bayley-III) at 12 and 18 months; anemia and infection incidence were also monitored.
Main Results:
- Neither iron syrup nor micronutrient powders with malaria chemoprevention improved cognitive scores compared to malaria chemoprevention alone.
- Iron interventions increased ferritin levels but did not reduce anemia prevalence.
- No increased malaria risk was observed with iron interventions; malaria chemoprevention alone reduced malaria incidence.
Conclusions:
- Six-month universal iron interventions with malaria chemoprevention did not yield significant cognitive benefits for children in Malawi.
- The findings suggest that these interventions may not be effective for improving neurodevelopmental outcomes in this population.
- Further research is needed to understand the complex interplay between iron, anemia, and child development in malaria-endemic settings.
Importance:
The World Health Organization recommends universal preventive iron interventions for young children in anemia-prevalent areas to alleviate the effects of anemia on child neurodevelopment and other outcomes. However, the functional benefits have not been confirmed in randomized clinical trials and there are concerns that iron interventions may increase infection risk.
Objective:
To determine whether universal iron interventions administered with malaria chemoprevention improve child functional outcomes and are safe regarding infection risk.
Design, Setting, And Participants:
This randomized clinical trial enrolled 6-month-old infants at 4 centers in southern Malawi, which is a rural, malaria-endemic setting. Enrollment occurred between April 2020 and October 2021. The final assessment was completed in October 2022.
Interventions:
Six months of (1) iron syrup and malaria chemoprevention (n = 542), (2) iron-containing micronutrient powders and malaria chemoprevention (n = 543), (3) malaria chemoprevention alone (n = 541), or (4) placebo alone (n = 542). Children were assessed after the 6-month intervention period and after 6-month follow-up.
Main Outcomes And Measures:
The primary outcome was the Cognitive Scale composite score at the end of the intervention period using the Bayley Scales of Infant and Toddler Development-Third Edition (Bayley-III). The secondary outcomes included Bayley-III Language Scale and Motor Scale composite scores, anemia prevalence, and concentrations of hemoglobin and ferritin. The primary and secondary outcomes were measured when children were 1 year of age and when they were 18 months of age. The safety outcomes included incidence of infection (including malaria).
Results:
A total of 2168 infants (mean age, 5.7 months; 49% were female; and 71% had anemia) were recruited to participate. Compared with malaria chemoprevention alone, there was no between-group difference in the Bayley-III Cognitive Scale composite score for iron syrup and malaria chemoprevention (mean difference [MD], -0.52 [95% CI, -2.52 to 1.48]). Compared with malaria chemoprevention alone, there was no between-group difference in the Bayley-III Cognitive Scale composite score for iron-containing micronutrient powders and malaria chemoprevention (MD, -0.85 [95% CI, -2.80 to 1.09]). Compared with placebo alone, there was no between-group difference in the Bayley-III Cognitive Scale composite score for malaria chemoprevention alone (MD, 1.62 [95% CI, -0.31 to 3.55]). Although the 2 iron interventions increased ferritin concentration, neither reduced anemia prevalence compared with malaria chemoprevention alone. Compared with malaria chemoprevention alone, neither iron syrup and malaria chemoprevention nor iron-containing micronutrient powders and malaria chemoprevention increased malaria risk. Compared with placebo alone, malaria chemoprevention alone reduced the incidence of malaria.
Conclusions And Relevance:
Two universal, 6-month iron interventions with malaria chemoprevention did not improve cognitive outcomes among children in Malawi.
Trial Registration:
anzctr.org.au Identifier: ACTRN12620000386932.
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