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Low-dose iron supplementation reduces behavioral problems in healthy infants at 3 yearsLow-dose iron in infancy linked to fewer behavior problems at age 3

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Key Takeaway
Consider low-dose iron supplementation for predominantly breastfed infants to potentially reduce behavioral problems, but await replication.

This randomized controlled trial enrolled 221 full-term, healthy, predominantly breastfed infants who were non-anemic at baseline in Warsaw, Poland and Umeå, Sweden. Infants received daily low-dose iron supplementation (7, 10, or 15 mg micronized microencapsulated ferric pyrophosphate) or placebo. The primary outcome was not reported; behavioral problems were assessed as a secondary outcome using the Child Behavior Checklist (CBCL) at 3 years of follow-up.

At 3 years, CBCL externalizing T-scores were significantly lower in the iron group compared to placebo (45.6 [8.5] vs. 48.6 [8.9], P =.006). Lower scores for aggressive behaviors were also observed in the iron group (P =.0329). Effect sizes for aggressive behaviors were not reported.

Safety data including adverse events, serious adverse events, discontinuations, and tolerability were not reported. The study notes that cautious interpretation is warranted until replicated in future studies. This was a pre-specified secondary outcome analysis, and the results suggest a potential beneficial effect.

For clinicians, low-dose iron supplementation may contribute to fewer behavioral problems at 3 years of age in predominantly breastfed healthy infants, but the evidence is preliminary and requires confirmation.

How this fits prior evidence

This RCT extends prior coverage on iron supplementation by demonstrating a potential behavioral benefit in healthy infants, whereas previous items focused on iron deficiency anemia in dancers and iron dosing in peritoneal dialysis. It contrasts with the PALaDIN study's focus on high vs. low dose iron in dialysis patients, as this trial used low-dose iron in a different population. The finding adds to the limited evidence on supplement effects in healthy infants, consistent with the cautious framing in prior coverage.

Could a simple daily supplement in infancy help prevent behavior problems later? A new study suggests low-dose iron might make a difference.

Researchers in Poland and Sweden followed 221 healthy, full-term, predominantly breastfed infants who were not anemic. Half received a daily low-dose iron supplement (7 to 15 mg), while the other half got a placebo. Three years later, parents filled out a standard behavior checklist.

Children who had received iron scored significantly lower on externalizing behaviors (like aggression and acting out) compared to the placebo group. The average externalizing T-score was 45.6 in the iron group versus 48.6 in the placebo group. Aggressive behaviors were also notably lower.

But the researchers urge caution. This was a secondary analysis, meaning it wasn't the main question the study was designed to answer. The results need to be confirmed in future studies before any recommendations can be made. If you're a parent, talk to your pediatrician before giving your baby any supplements.

What this means for you:
Low-dose iron in infancy may reduce behavior problems at age 3, but more research is needed.

Common questions

Should I give my baby iron supplements based on this study?

Not yet. The study found a link between low-dose iron and fewer behavior problems, but it was a secondary analysis. The researchers say cautious interpretation is warranted until the results are replicated. Always talk to your pediatrician before giving your baby any supplement.

What does 'externalizing behaviors' mean?

Externalizing behaviors are actions directed outward, like aggression, acting out, or breaking rules. In this study, children who received iron had lower scores on these behaviors compared to those who got a placebo.

How much iron did the babies get?

The babies received a daily low-dose iron supplement of 7, 10, or 15 mg of micronized microencapsulated ferric pyrophosphate. The exact dose varied, but all were considered low-dose.

Were there any side effects reported?

The study did not report any adverse events, serious adverse events, or discontinuations due to side effects. However, the safety data was not detailed, so it's unclear if any mild side effects occurred.

Study Details

Study typeRct
Sample sizen = 221
EvidenceLevel 2
Follow-up9.0 mo
PublishedJun 2026
View Original Abstract ↓
Breastfed infants are particularly vulnerable to iron deficiency, which is associated with impaired neurodevelopment. Iron supplementation reduces behavioral problems in certain risk groups, but effects in healthy infants are uncertain. This randomized, double-blind, placebo-controlled trial evaluated whether daily low-dose iron supplementation (7, 10, or 15 mg micronized microencapsulated ferric pyrophosphate, approximating 1 mg/kg, from 4 to 9 months of age) affects behavioral outcomes at 3 years. The study was conducted in Warsaw, Poland and Umeå, Sweden and included full-term, healthy, predominantly breastfed infants who were non-anemic at baseline. Behavioral problems were assessed using the Child Behavior Checklist (CBCL) at 3 years as a pre-specified secondary outcome. Of the 221 participants randomized, 133 (60%) completed the CBCL. Iron supplementation compared to placebo significantly reduced CBCL externalizing T-scores (mean [SD], 45.6 [8.5] vs. 48.6 [8.9], adjusted P = .006). Lower scores were also observed for aggressive behaviors (adjusted P = .0329). This pre-specified secondary outcome analysis found that low-dose iron supplementation in predominantly breastfed healthy infants between 4 and 9 months of age may contribute to fewer behavioral problems at 3 years of age. These findings suggest a potential beneficial effect, though cautious interpretation is warranted until replicated in future studies.Trial registration: clinicaltrials.gov; identifying number: NCT02242188; URL: http://www.clinicaltrials.gov/study/NCT02242188 ; Date of registration: 2014-09-14.
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