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A new study published in JAMA Pediatrics has provided significant insights into the necessity of iron supplements for breastfed infants, challenging longstanding recommendations by the American Pediatric Association.

The SIDBI trial, an international collaborative effort between the Medical University of Warsaw and Umeå University, sought to determine the impact of iron supplementation on the psychomotor development of breastfed infants. This study was prompted by differing guidelines: while the American Pediatric Association advocates for iron supplements for infants who breastfeed beyond four months, the European Society of Gastroenterology, Hepatology, and Nutrition does not.

Study Design and Methodology

The Supplementing Iron and Development in Breastfed Infants (SIDBI) trial, conducted from December 2015 to May 2020 with follow-up until May 2023, was a randomized, placebo-controlled trial. It included 221 infants from Poland and Sweden who were exclusively breastfed at four months. These infants were randomly assigned to receive either 1 mg/kg of iron or a placebo daily from 4 to 9 months of age.

The children’s cognitive, motor, and language abilities, along with behavioral problems, were evaluated by psychologists at 12, 24, and 36 months. The aim was to fill a knowledge gap regarding the benefits of iron supplementation on early development.

Key Findings

According to Ludwig Svensson, a Ph.D. student involved in the SIDBI trial, the study found no significant differences in psychomotor development between infants who received iron supplements and those who received a placebo.

“We did not see any significant differences in psychomotor development between children who received extra iron and children who received placebo,” Svensson explained. “In other words, there was no benefit from iron supplements for development. More children in the placebo group had iron deficiency, but the difference was not significant.”

Implications and Future Research

The results provide robust evidence supporting the European guidelines that do not recommend routine iron supplementation for all healthy breastfed infants. This contrasts with the American recommendation, suggesting a reevaluation might be necessary.

“We are proud to have published the results in JAMA Pediatrics, and we hope for a lot of attention for the study,” said Svensson. “Our results provide high-quality evidence in the field where randomized trials were lacking.”

Looking ahead, Svensson and his team plan to delve deeper into the SIDBI study data, particularly examining behavioral problems at the age of three to see if iron supplements influence behaviors associated with ADHD or autism spectrum disorders.

The study’s findings are expected to generate considerable discussion and could potentially influence pediatric guidelines on iron supplementation for breastfed infants worldwide.

More Information: Ludwig Svensson et al, “Effect of Low-Dose Iron Supplementation on Early Development in Breastfed Infants,” JAMA Pediatrics (2024).

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