Document Detail

Clinical safety of iron-fortified formulas.
MedLine Citation:
PMID:  10699140     Owner:  NLM     Status:  MEDLINE    
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.
A Singhal; R Morley; R Abbott; S Fairweather-Tait; T Stephenson; A Lucas
Publication Detail:
Type:  Clinical Trial; Journal Article; Randomized Controlled Trial; Research Support, Non-U.S. Gov't    
Journal Detail:
Title:  Pediatrics     Volume:  105     ISSN:  1098-4275     ISO Abbreviation:  Pediatrics     Publication Date:  2000 Mar 
Date Detail:
Created Date:  2000-03-21     Completed Date:  2000-03-21     Revised Date:  2006-11-15    
Medline Journal Info:
Nlm Unique ID:  0376422     Medline TA:  Pediatrics     Country:  UNITED STATES    
Other Details:
Languages:  eng     Pagination:  E38     Citation Subset:  IM    
Medical Research Council Childhood Nutrition Research Centre, Institute of Child Health, London, United Kingdom.
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MeSH Terms
Constipation / etiology
Diarrhea / etiology
Ferritins / blood
Food, Fortified / adverse effects*
Infant Food / adverse effects*,  analysis
Iron / administration & dosage*
Reg. No./Substance:
7439-89-6/Iron; 9007-73-2/Ferritins

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine

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