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Dose-response trial of prophylactic zinc supplements, with or without copper, in young Ecuadorian children at risk of zinc deficiency^1,2,3

¹ From the Department of Nutrition, Program in International and Community Nutrition, University of California, Davis, Davis, CA (SEW and KHB), and the Central University of Ecuador, Quito, Ecuador (FS)

Background: Multiple studies have shown the benefits of zinc supplementation among young children in high-risk populations. However, the optimal dose and safe upper level of zinc have not been determined.

Objectives: The objectives of this study were to measure the effects of different doses of supplemental zinc on the plasma zinc concentration, morbidity, and growth of young children; to detect any adverse effects of 10 mg supplemental Zn on markers of copper or iron status; and to determine whether any adverse effects are alleviated by providing copper with zinc.

Design: This randomized, double-masked, community-based intervention trial was conducted in 631 Ecuadorian children who were 12–30 mo old at baseline and who had initial length-for-age z scores <–1.3. Children received 1 of 5 daily supplements for 6 mo: 3, 7, or 10 mg Zn as zinc sulfate, 10 mg Zn + 0.5 mg Cu as copper sulfate, or placebo.

Results: The change in plasma zinc concentration from baseline was positively related to the zinc dose (P < 0.001). Zinc supplementation, including doses as low as 3 mg/d, reduced the incidence of diarrhea by 21–42% (P < 0.01). There were no other significant group-wise differences.

Conclusions: Zinc supplementation with a dose as low as 3 mg/d increased plasma zinc concentrations and reduced diarrhea incidence in the study population. There were no observed adverse effects of 10 mg Zn/d on indicators of copper or iron status. The current tolerable upper level of zinc recommended by the Institute of Medicine should be reassessed for young children.

Key Words: Zinc • copper • dose response • tolerable upper level • diarrhea • lipoprotein concentration • iron • growth response

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