Trial reportThe Journal of pediatrics2019
Randomized Controlled Trial of Iron-Fortified versus Low-Iron Infant Formula: Developmental Outcomes at 16 Years.
Trial report in The Journal of pediatrics, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01166451 (Iron Deficiency Anemia and Infant Behavior), which is not on this map. Cited by 27 papers, 1 of them a synthesis that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Iron Deficiency Anemia and Infant Behavior: Preventive Trial
Who cites it
27 citing papers in PubMed, 1 synthesis or guideline pooled it, 38 citations in OpenAlex.
- Effect of iron supplements on cognitive development in children: an umbrella review.Frontiers in nutrition · 2026Pooled it
- Interventional impact of liposomal iron on iron-deficient children developmental outcome: randomized, double-blind, placebo-controlled trial.Pediatric research · 2025Trial
- Iron supplementation given to nonanemic infants: neurocognitive functioning at 16 years.Nutritional neuroscience · 2023Trial
- Young adult outcomes associated with lower cognitive functioning in childhood related to iron-fortified formula in infancy.Nutritional neuroscience · 2022Trial
- Trial
- Iron Supplementation and Copper Homeostasis: Evidence for Potential Copper Depletion, Biomarker Challenges, and Clinical Implications.Nutrients · 2026Review
- Iron Supplementation and Neurodevelopmental Outcomes in Infancy and Early Childhood: A Review.Children (Basel, Switzerland) · 2026Review
- Food and Drug Administration Expert Panel on Infant Formula "Operation Stork Speed" June 2025: Part 1, Nutrient Considerations.Advances in nutrition (Bethesda, Md.) · 2026Review
- MENA Delphi consensus on iron deficiency anemia in infants and young children: screening, management, and prevention strategies.Frontiers in nutrition · 2026Article
- Iron Deficiency and Iron Deficiency Anemia: A Comprehensive Overview of Established and Emerging Concepts.Pharmaceuticals (Basel, Switzerland) · 2025Review
- Prevention of anemia in children through the consumption of a blueberry and quinoa drink enriched with iron as part of a nutritional program.Frontiers in nutrition · 2025Article
- Scientific opinion on the tolerable upper intake level for iron.EFSA journal. European Food Safety Authority · 2024Article
- Iron Fortification and Inulin Supplementation in Early Infancy: Evaluating the Impact on Iron Metabolism and Trace Mineral Status in a Piglet Model.Current developments in nutrition · 2024Article
- Perturbed iron biology in the prefrontal cortex of people with schizophrenia.Molecular psychiatry · 2023Article
- Perspective: Is It Time to Revise the Current Nutrient Requirements for Infant Formulas Principally Established in 1980?Advances in nutrition (Bethesda, Md.) · 2023Article
- Iron and DHA in Infant Formula Purchased in the US Fails to Meet European Nutrition Requirements.Nutrients · 2023Article
- Iron status, development, and behavior in young children in the Pennsylvania foster care system.PloS one · 2023Article
- Benefits and Risks of Early Life Iron Supplementation.Nutrients · 2022Review
- Article
- Dietary Approaches to Iron Deficiency Prevention in Childhood-A Critical Public Health Issue.Nutrients · 2022Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
5 authors at 4 institutions in 2 countries.
Funding
Abstract
objectivesTo test differences in cognitive outcomes among adolescents randomly assigned previously as infants to iron-fortified formula or low-iron formula as part of an iron deficiency anemia prevention trial. STUDY
designInfants were recruited from community clinics in low- to middle-income neighborhoods in Santiago, Chile. Entrance criteria included term, singleton infants; birth weight of ≥3.0 kg; and no major congenital anomalies, perinatal complications, phototherapy, hospitalization >5 days, chronic illness, or iron deficiency anemia at 6 months. Six-month-old infants were randomized to iron-fortified (12 mg/L) or low-iron (2.3 mg/L) formula for 6 months. At 16 years of age, cognitive ability, visual perceptual ability, visual memory, and achievement in math, vocabulary, and comprehension were assessed, using standardized measures. We compared differences in developmental test scores according to randomization group.
resultsAt the follow-up assessment, the 405 participants averaged 16.2 years of age and 46% were male. Those randomized to iron-fortified formula had lower scores than those randomized to low-iron formula for visual memory, arithmetic achievement, and reading comprehension achievement. For visual motor integration, there was an interaction with baseline infancy hemoglobin, such that the iron-fortified group outperformed the low-iron group when 6-month hemoglobin was low and underperformed when 6-month hemoglobin was high.
conclusionsAdolescents who received iron-fortified formula as infants from 6 to 12 months of age at levels recommended in the US had poorer cognitive outcomes compared with those who received a low-iron formula. The prevention of iron deficiency anemia in infancy is important for brain development. However, the optimal level of iron supplementation in infancy is unclear.
trial registrationClinicaltrials.gov: NCT01166451.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.