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Open AccessProtocol

Study Protocol for a Randomized, Double-Blind, Community-Based Efficacy Trial of Various Doses of Zinc in Micronutrient Powders or Tablets in Young Bangladeshi Children

1
Nutrition and Clinical Services Division, International Centre for Diarrhoeal Disease Research, Bangladesh (icddr,b), Dhaka 1212, Bangladesh
2
Children’s Hospital Oakland Research Institute, Oakland, CA 94609, USA
3
Department of Pediatrics, University of Colorado Denver Anschutz Medical Campus, Aurora, CO 80045, USA
4
Maternal and Child Health Division, International Centre for Diarrhoeal Disease Research, Bangladesh (icddr,b), Dhaka 1212, Bangladesh
5
Institute for International Programs, Bloomberg School of Public Health, Johns Hopkins University, Baltimore, MD 21205, USA
*
Author to whom correspondence should be addressed.
Nutrients 2018, 10(2), 132; https://doi.org/10.3390/nu10020132
Received: 6 December 2017 / Revised: 14 January 2018 / Accepted: 16 January 2018 / Published: 26 January 2018
(This article belongs to the Special Issue Dietary Zn and Human Health)
Zinc is essential to supporting growth in young children especially for tissues undergoing rapid cellular differentiation and turnover, such as those in the immune system and gastrointestinal tract. Therapeutic zinc supplementation has been initiated in low-income countries as part of diarrhea treatment programs to support these needs for young children, but the effects of preventive supplemental zinc as a tablet or as a multiple micronutrient powder (MNP) on child growth and diarrheal disease are mixed and pose programmatic uncertainties. Thus, a randomized, double-blind community-based efficacy trial of five different doses, forms, and frequencies of preventive zinc supplementation vs. a placebo was designed for a study in children aged 9–11 months in an urban community in Dhaka, Bangladesh. The primary outcomes of this 24-week study are incidence of diarrheal disease and linear growth. Study workers will conduct in-home morbidity checks twice weekly; anthropometry will be measured at baseline, 12 weeks and 24 weeks. Serum zinc and other related biomarkers will be measured in a subsample along with an estimate of the exchangeable zinc pool size using stable isotope techniques in a subgroup. Therapeutic zinc will be provided as part of diarrhea treatment, in accordance with Bangladesh’s national policy. Therefore, the proposed study will determine the additional benefit of a preventive zinc supplementation intervention. The protocol has been approved by the Institutional Review Boards (IRBs) of icddr,b and Children’s Hospital Oakland Research Institute (CHORI). The IRB review process is underway at the University of Colorado Denver as well. View Full-Text
Keywords: zinc; multiple micronutrient powder; diarrhea; linear growth; infants; exchangeable zinc pool size zinc; multiple micronutrient powder; diarrhea; linear growth; infants; exchangeable zinc pool size
MDPI and ACS Style

Islam, M.M.; McDonald, C.M.; Krebs, N.F.; Westcott, J.; Rahman, A.E.; El Arifeen, S.; Ahmed, T.; King, J.C.; Black, R.E. Study Protocol for a Randomized, Double-Blind, Community-Based Efficacy Trial of Various Doses of Zinc in Micronutrient Powders or Tablets in Young Bangladeshi Children. Nutrients 2018, 10, 132.

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