Prevention of iron-deficiency anemia: Comparison of high- and low-iron formulas in term healthy infants after six months of life,☆☆,,★★,

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Abstract

Objectives: For bottle-fed babies or nursing infants who receive milk supplements, the American Academy of Pediatrics recommends the use of iron-fortified infant formula. Because these recommendations have not been universally adopted, the hematologic effects of currently available low-iron formulas need to be determined. Study Design: Healthy Chilean 6-month-old infants (without iron-deficiency anemia, born at term weighing ≥ 3.0 kg) who were totally or partially weaned from the breast were randomly allocated in a double-blind fashion to receive high-iron (n = 430) or low-iron formula (n = 405), containing an average of 12.7 mg/L or 2.3 mg/L, respectively, of elemental iron as ferrous sulfate. Iron status was determined at 12 months. Results: The prevalence of iron-deficiency anemia was not different in the high- and low-iron groups (2.8% versus 3.8%, p = 0.35). Nevertheless, infants receiving high-iron formula had somewhat higher levels of hemoglobin and serum ferritin, greater mean cell volumes, and lower erythrocyte protoporphyrin levels (p < 0.005). Conclusions: Although high-iron formulas are more efficacious in improving iron status, currently available low-iron formulas may prevent iron-deficiency anemia in selected healthy, term infant populations with otherwise poor sources of dietary iron after 6 months of life. Formulas with relatively small amounts of iron appear to prevent iron-deficiency anemia. We speculate that the optimal level of iron fortification likely lies somewhere between the current levels in high- and low-iron formulas. (J Pediatr 1998;132:635-40.)

Section snippets

Setting

Chile is a South American democracy with a highly literate population and a comprehensive health care system. According to Chilean custom, almost all babies are breast fed in the early months and about 50% continue to breast feed up to 6 months of age. However, unmodified powdered cow's milk is distributed free of charge at all health maintenance visits as part of a long-standing, highly effective program to prevent malnutrition. Routine pediatric care and infant feeding practices in Chile

Results

Eight hundred thirty-five infants completed the trial, randomly assigned to receive low-iron formula (n = 405) or high-iron formula (n = 430). The two groups were similar with respect to demographic characteristics, infant growth, formula consumption, and most measures of breast feeding (Table I).

. Background factors, growth, and feeding

Empty CellLow-iron (n = 405)High-iron (n = 430)
Demographics
 Sex (% male)5252
 Mother's age (yr)26.4 ± 5.826.6 ± 6.1
 Mother's education (yr)9.4 ± 2.79.4 ± 0.6
 Family members

Discussion

This study shows that newer preparations of low-iron formula are meeting infant iron needs better than expected, even in a developing country where other sources of iron are limited in the first year of life. In this study, low-iron formula was not significantly inferior to iron-fortified formula in the prevention of iron-deficiency anemia. However, iron-deficiency anemia is a late manifestation of iron deficiency. A greater proportion of infants in the low-iron group was iron deficient at 12

Acknowledgements

We are grateful to Angelica Letelier, Marisol Cayazzo, and Pamela Cea for excellent technical assistance, to the project's External Advisory Committee (Peter Dallman, Ernesto Pollitt, Fernando Viteri, and Ray Yip) for expert advice and continued counsel and support, and to the Centers for Disease Control for performing the lead determinations.

References (23)

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    From the Hematology Unit, Institute of Nutrition and Food Technology (INTA), University of Chile, Santiago, Chile; the Department of Public Health, Faculty of Medicine, University of Chile; and the Center for Human Growth and Development and Department of Pediatrics and Communicable Diseases, University of Michigan, Ann Arbor, Michigan.

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    Supported by a grant from the National Institutes of Health (Iron Deficiency Anemia and Infant Behavior, HD 14122, Betsy Lozoff, Principal Investigator).

    The low- and high-iron formulas (Similac) were donated by Abbott-Ross Laboratories, Columbus, Ohio.

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    Reprint requests: Tomas Walter, MD, Hematology Unit, INTA, University of Chile, 5540 Macul, Santiago, Chile 11-138.

    9/21/85031

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