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Clinical safety of iron-fortified formulas
A Singhal1, R Morley, R Abbott
1Medical Research Council Childhood Nutrition Research Centre, Institute of Child Health, London, United Kingdom. a.singhal@ich.ucl.ac.uk
Insights
High-iron infant formula is safe for older infants and toddlers, showing no increased risk of infection or gastrointestinal issues. This study supports the use of iron-fortified formulas for infant nutrition.
Area of Science:
- Pediatric Nutrition
- Iron Metabolism
- Infant Health
Background:
- Iron-fortified formulas are standard for infants but their long-term safety is not well-established.
- Concerns exist regarding potential pro-oxidant effects and gastrointestinal disturbances from iron fortification.
Purpose of the Study:
- To test if iron-fortified formula increases infection or gastrointestinal problems in infants compared to low-iron or cow's milk.
- To evaluate the safety of iron fortification in infant formulas.
Main Methods:
- A randomized controlled trial involving 493 nine-month-old infants.
- Infants were assigned to cow's milk, low-iron formula (.9 mg/L), or high-iron formula (12 mg/L).
- Outcomes including infections, gastrointestinal issues, and morbidity were recorded up to 18 months.
Main Results:
- Infants on high-iron formula showed increased serum ferritin levels.
- No significant differences were observed in infection rates, gastrointestinal problems, general morbidity, or weight gain between groups.
- Iron status was assessed at 18 months.
Conclusions:
- Consuming high-iron formula (12 mg/L) did not lead to adverse health effects in older infants and toddlers.
- The study found no increased risk of infection or gastrointestinal issues with high-iron formula use.
- These findings are relevant even in populations with low iron deficiency prevalence.
Background:
Iron-fortified formulas are recommended throughout infancy and are frequently used beyond, yet safety aspects have been inadequately studied. Iron could theoretically increase pro-oxidant stress, with potential adverse effects, including infection risk, and some clinicians suspect that iron-fortified formulas induce gastrointestinal disturbance.
Objective:
A planned component of a large intervention trial has been to test the hypothesis that infants receiving iron-fortified formula do not have a higher incidence of infections (primary outcome) or gastrointestinal problems (secondary outcome) than infants on low iron-formulas or cow's milk. Methods. Children (n = 493) 9 months old receiving cow's milk were recruited in 3 UK centers and randomized to: 1) cow's milk as before, 2) formula containing.9 mg/L of iron, or 3) an otherwise identical formula but containing 12 mg/L of iron. Children were followed at 3 monthly intervals and the episodes of infections, diarrhea and constipation, and general morbidity to 18 months old were recorded. Hematologic indices of iron status were determined at 18 months old.
Results:
Serum ferritin concentrations were increased in infants receiving iron-fortified formula but there were no intergroup differences in incidence of infection, gastrointestinal problems, or in general morbidity or weight gain.
Conclusions:
We were unable to identify adverse health effects in older infants and toddlers consuming a high iron-containing formula (12 mg/L) even when used in populations with a low incidence of iron deficiency.