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Summary

for people ages 9 months to 11 months (full criteria)
healthy people welcome
study started
estimated completion:

Description

Summary

This is a randomized, double-blind, community-based efficacy trial of different doses, forms, and frequencies of zinc supplementation for the prevention of diarrhea and promotion of linear growth among children 9-11 months of age in Dhaka, Bangladesh.

Official Title

Randomized, Double-blind, Community-based Efficacy Trial of Various Doses of Zinc in Micronutrient Powders or Tablets in Young, Bangladeshi Children

Details

Zinc is essential to support 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.

Keywords

Diarrhea Stunting Zinc Multiple micronutrient powders Growth Disorders Iron Trace Elements Micronutrients

Eligibility

You can join if…

Open to people ages 9 months to 11 months

  • 9-11 months of age
  • Weight-for-length Z score >= -3 according to the 2006 WHO Growth Standards

You CAN'T join if...

  • Presence of severe acute malnutrition, defined as a WLZ <-3 and/or the presence of bipedal edema and/or mid-upper arm circumference <115 mm;
  • Congenital anomalies (e.g. cardiac defects, cleft lip or palate) or any other conditions that interfere with feeding;
  • Chromosomal anomalies and other organic problems (e.g. jaundice, tuberculosis)
  • Currently consuming MNPs with no intention of stopping

Details

Status
not yet accepting patients
Start Date
Completion Date
(estimated)
Sponsor
Christine McDonald
ID
NCT03406793
Study Type
Interventional
Last Updated
January 19, 2018
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