PEDIATRICS Vol. 88 No. 2 August 1991, pp. 320-326
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Randomized, Placebo-Controlled Trial of Iron Supplementation in Infants With Low Hemoglobin Levels Fed Iron-Fortified Formula

Matilde Irigoyen MD1, Leslie L. Davidson MD, MSc2, Damaris Carriero MS3, and Carol Seaman MS3

1 From the Division of General Pediatrics, Columbia University, and Babies Hospital, New York, New York
2 From the Division of General Pediatrics, Sergievsky Center and School of Public Health, Columbia University, and Babies Hospital, New York, New York
3 From the Divisions of Hematology/Oncology, Department of Pediatrics, Columbia University, and Babies Hospital, New York, New York

In spite of the declining prevalence of irodeficiency anemia, a large proportion of low-income infants have "low-normal" (11-11.5 g/dL) and "low" (< 11 g/dL) hemoglobin (Hgb) values. Because most of these infants are fed iron-fortified formulas, it was of interest whether additional iron supplementation would enhance Hgb values. A cohort of 334 healthy, inner-city, minority, 6-month-old infants, fed iron-fortified formulas, with Hgb values ranging from 9 to 11.5 g/dL, participated in a double-blind, randomized, placebo-controlled trial of supplemental iron at 0, 3, and 6 mg/kg per day for 3 months. Hemoglobin values increased significantly with age, regardless of assignment to placebo or supplemental iron (means for the entire cohort: 6 months 10.9 g/dL, 8 months 11.2, 10 months 11.3, and 12 months 11.4). The proportion of "responders" (Hgb level increased ge1 g/dL) was 34% and did not differ significantly by placebo or iron dose. There were no significant differences in mean corpuscular volume or levels of erythrocyte porphyrins or serum ferritin between treatment groups. The implications of this clinical trial are twofold: (1) screening healthy infants fed iron-fortified formula at the age of 6 months is not justified, regardless of socioeconomic status; (2) the clinical practice of routinely treating low-income, "low-Hgb" infants with iron supplementation, without regard to dietary considerations, is unwarranted.

Key Words: hemoglobin level • iron-deficiency anemia • infant formula • iron supplementation

Submitted on October 14, 1990
Accepted on December 26, 1990




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