A double-masked, randomized control trial of iron supplementation in early infancy in healthy term breast-fed infants.
OBJECTIVE
To test whether iron supplementation affects hematologic, biochemical, and developmental status in term breast-fed infants.


METHODS
Term breast-fed infants (n=77) were randomly selected to receive either 7.5 mg per day of elemental iron as ferrous sulfate or placebo from 1 to 6 months of age. Investigators and families were unaware of group assignment. Complete blood count and ferritin, red cell superoxide dismutase, catalase, plasma ferric reducing antioxidant power, and zinc and copper levels were analyzed at 1, 3.5, 6, and 12 months of age. Bayley mental and psychomotor developmental indexes (MDI and PDI) and visual acuity (with the use of Teller acuity cards) were assessed from 12 to 18 months of age. Analysis performed by analysis of variance and t tests was by intention to treat.


RESULTS
Iron supplementation resulted in higher hemoglobin and mean corpuscular volume at 6 months of age and significantly higher visual acuity and PDI at 13 months of age (100+/-12 vs 93+/-9 [+/-SD]). Treatment and placebo groups did not differ in anthropometric indexes, compliance, biochemical status, or demographic characteristics.


CONCLUSIONS
Iron supplementation of breast-fed infants appears safe and might have beneficial hematologic and developmental effects for some infants.
Friel
James K
JK
Department of Pediatrics, Memorial University of Newfoundland, St John's, Newfoundland, Canada. frielj@ms.umanitoba.ca
Aziz
Khalid
K
Andrews
Wayne L
WL
Harding
Scott V
SV
Courage
Mary L
ML
Adams
Russell J
RJ
D018798:Anemia, Iron-Deficiency / Q000453:epidemiology / Q000517:prevention & control; D001835:Body Weight; D001942:Breast Feeding / Q000706:statistics & numerical data; D002374:Catalase / Q000097:blood; D003071:Cognition / Q000187:drug effects; D003300:Copper / Q000097:blood; D019587:Dietary Supplements; D004311:Double-Blind Method; D005260:Female; D005293:Ferritins / Q000097:blood; D006801:Humans; D007223:Infant; D007227:Infant Nutritional Physiological Phenomena; D007231:Infant, Newborn; D007501:Iron / Q000008:administration & dosage* / Q000494:pharmacology; D008297:Male; D009048:Motor Skills / Q000187:drug effects; D011597:Psychomotor Performance / Q000187:drug effects; D013482:Superoxide Dismutase / Q000097:blood; D014792:Visual Acuity / Q000187:drug effects; D015032:Zinc / Q000097:blood
D003300:Copper; D005293:Ferritins; D007501:Iron; D002374:Catalase; D013482:Superoxide Dismutase; D015032:Zinc