Trial reportBMC pediatrics2019
Does the fortified milk with high iron dose improve the neurodevelopment of healthy infants? Randomized controlled trial.
Trial report in BMC 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 NCT02690675 (Iron Supplement Effect Over Immune System and Neurobehavioral Child Development.), which is not on this map. Cited by 7 papers, 2 of them syntheses that pooled it.
What it found
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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 Supplement Effect Over Immune System and Neurobehavioral Child Development.
Who cites it
7 citing papers in PubMed, 2 syntheses or guidelines pooled it, 9 citations in OpenAlex.
- Effects of iron intake on neurobehavioural outcomes in African children: a systematic review and meta-analysis of randomised controlled trials.Wellcome open research · 2021Pooled it
- The Role of Iron in Brain Development: A Systematic Review.Nutrients · 2020Pooled it
- Infant formula iron fortification of 2 vs. 8 mg/L does not increase the risk of iron deficiency or impact neurodevelopment at 12 months.Journal of pediatric gastroenterology and nutrition · 2026Trial
- Iron Supplementation and Neurodevelopmental Outcomes in Infancy and Early Childhood: A Review.Children (Basel, Switzerland) · 2026Review
- Iron Complexes With Proteins, Carbohydrates, and Maillard Products in Dairy Systems: Implication for Fortification, Bioavailability, and Product Functionality.Comprehensive reviews in food science and food safety · 2026Review
- Benefits and Risks of Early Life Iron Supplementation.Nutrients · 2022Review
- Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
12 authors at 3 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundSince iron plays an important role in several physiological processes, its deficiency but also overload may harm the development of children. The aim was to assess the effect of iron-fortified milk on the iron biochemical status and the neurodevelopment of children at 12 months of age.
methodsRandomized controlled trial conducted in 133 Spanish children, allocated in two groups to receive formula milk fortified with 1.2 or 0.4 mg/100 mL of iron between 6 and 12 months of age. Psychomotor (PDI) and Mental (MDI) Development Index were assessed by the Bayley Scales before and after the intervention. Maternal obstetrical and psychosocial variables were recorded. The biochemical iron status of children was measured and data about breastfeeding, anthropometry and infections during the first year of life were registered.
resultsChildren fortified with 1.2 mg/100 mL of iron, compared with 0.4 mg/100 mL, showed higher serum ferritin (21.5 vs 19.1 μg/L) and lower percentage of both iron deficiency (1.1 to 5.9% vs 3.8 to 16.7%, respectively, from 6 to 12 months) and iron deficiency anemia (4.3 to 1.1% vs 0 to 4.2%, respectively, from 6 to 12 months) at the end of the intervention. No significant differences were found on neurodevelopment from 6 to 12 months between children who received high dose of Fe compared with those who received low dose.
conclusionDespite differences on the iron status were observed, there were no effects on neurodevelopment of well-nourished children in a developed country after iron supplementation with doses within dietary recommendations. Follow-up studies are needed to test for long-term neurodevelopmental improvement.
trial registrationRetrospectively registered in ClinicalTrials.gov with the ID: NCT02690675.
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