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

M. Munirul Islam, Christine M. McDonald, Nancy F. Krebs, Jamie Westcott, Ahmed Ehsanur Rahman, Shams El Arifeen, Tahmeed Ahmed, Janet C. King, Robert E Black

Research output: Contribution to journalArticle

Abstract

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.

Original languageEnglish (US)
Article number132
JournalNutrients
Volume10
Issue number2
DOIs
StatePublished - Feb 1 2018

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Micronutrients
dietary minerals
Powders
Tablets
Zinc
powders
zinc
dosage
Research Ethics Committees
diarrhea
Diarrhea
Growth
child growth
therapeutics
Anthropometry
Bangladesh
anthropometric measurements
Therapeutics
placebos
gastrointestinal system

Keywords

  • Diarrhea
  • Exchangeable zinc pool size
  • Infants
  • Linear growth
  • Multiple micronutrient powder
  • Zinc

ASJC Scopus subject areas

  • Food Science
  • Nutrition and Dietetics

Cite this

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. / Islam, M. Munirul; McDonald, Christine M.; Krebs, Nancy F.; Westcott, Jamie; Rahman, Ahmed Ehsanur; El Arifeen, Shams; Ahmed, Tahmeed; King, Janet C.; Black, Robert E.

In: Nutrients, Vol. 10, No. 2, 132, 01.02.2018.

Research output: Contribution to journalArticle

Islam, M. Munirul ; McDonald, Christine M. ; Krebs, Nancy F. ; Westcott, Jamie ; Rahman, Ahmed Ehsanur ; El Arifeen, Shams ; Ahmed, Tahmeed ; King, Janet C. ; Black, Robert 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. In: Nutrients. 2018 ; Vol. 10, No. 2.
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