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Early iron supplementation in exclusively breastfed Gambian infants: a randomized controlled trial
Mamadou Bah1, Isabella Stelle2, Hans Verhoef3
1Medical Research Council Unit, The Gambia at the London School of Hygiene & Tropical Medicine, Atlantic Boulevard, Fajara, PO Box 273, Banjul, Gambia.
Insights
Daily iron supplementation significantly improved iron status in exclusively breastfed Gambian infants. This intervention showed no adverse effects on growth or infections, highlighting its safety and efficacy.
Area of Science:
- Pediatric Nutrition
- Hematology
- Public Health Interventions
Background:
- Iron deficiency is a significant concern in exclusively breastfed infants.
- Early iron supplementation is crucial for infant development and preventing anemia.
- Understanding iron status in vulnerable populations like those in Gambia is vital.
Purpose of the Study:
- To evaluate the impact of daily iron supplementation on serum iron and iron status markers.
- To assess the safety and efficacy of iron supplementation in exclusively breastfed infants.
- To investigate iron status in infants in rural Gambia.
Main Methods:
- A placebo-controlled, randomized, double-blind trial was conducted.
- 101 exclusively breastfed infants (6-10 weeks) in Gambia received daily iron (7.5 mg) or placebo for 98 days.
- Serum iron, iron status, and hematological markers were measured at baseline and day 99.
Main Results:
- Iron supplementation led to significantly higher serum iron concentrations (2.5 µmol/L difference).
- Improvements were observed in other iron and hematological markers.
- No significant differences in reported infant infections or adverse events between groups.
Conclusions:
- Daily iron supplementation from 6 weeks of age improves iron status in exclusively breastfed Gambian infants.
- The intervention demonstrated a favorable safety profile with no increased risk of infections or growth impairment.
- Iron supplementation is a viable strategy to address iron deficiency in this population.
Objective:
To investigate the effect of daily iron supplementation for 14 weeks on the serum iron concentration and other markers of iron status in exclusively breastfed infants in Gambia.
Methods:
A placebo-controlled, randomized, double-blind trial was performed in rural Gambia between 3 August 2021 and 9 March 2022. Overall, 101 healthy, exclusively breastfed infants aged 6 to 10 weeks were recruited at vaccination clinics and through community health workers. Infants were randomized to receive iron supplementation (7.5 mg/day as ferrous sulfate in sorbitol solution) or placebo for 98 days. Venous blood samples were collected at baseline and on day 99 to assess the serum iron concentration and other markers of iron and haematological status.
Findings:
At day 99, the serum iron concentration was significantly higher in the iron supplementation group than the placebo group (crude difference in means: 2.5 µmol/L; 95% confidence interval: 0.6 to 4.3) and there were significant improvements in other iron and haematological markers. There were 10 serious adverse events (five in each group), 106 non-serious adverse events (54 with iron supplementation; 52 with placebo) and no deaths. There was no marked difference between the groups in maternally reported episodes of diarrhoea, fever, cough, skin infection, eye infection or nasal discharge.
Conclusion:
In exclusively breastfed Gambian infants, iron supplementation from 6 weeks of age was associated with a significant improvement in markers of iron status at around 6 months of age. There was no indication of adverse effects on growth or infections.
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