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Efficacy of Zinc Therapy in Acute Diarrhoea in Young Children

NCT00325247 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 2050

Last updated 2011-07-12

No results posted yet for this study

Summary

Diarrhoea continues to be a major cause of mortality and morbidity in young children especially in many developing countries. Although the mortality burden of diarrhoea has substantially reduced, the morbidity pattern remained almost unchanged. Recent randomized controlled supplementation trials in developing countries have consistently shown that zinc has the potential to reduce the duration of diarrhoea as well as has preventive effect on childhood diarhroea in subsequent months. Currently, international health agencies recommend zinc as an important adjunct therapy to treat diarrhoea in developing countries where zinc deficiency is highly prevalent and diet is poor in zinc.

The recommendation is to provide 20 mg elemental zinc daily for 10 days during each episode of diarrhoea.

This study aims at evaluating the relative efficacy of two length of 20 mg zinc therapy (5 vs 10 days) during acute diarrhoea in a rural community in a community-based individually randomized placebo-controlled trial with 20 mg zinc daily and will be conducted in seven villages in the ICDDR,B Matlab study area.

The study will require 2050 acute dirrhoeal episodes to be treated who will be randomly allocated to one of the two treatment schedules (20 mg of zinc daily for 5 or 10 days). Children who will be allocated to the shorter duration therapy will receive placebo for the remaining days to complete 10-day treatment. Female Field Workers (FFWs) will conduct diarrhoea surveillance and administer zinc daily at home. Data will be analyzed using appropriate statistical procedure.

Findings of this study will be immensely valuable for deciding recommendation for the duration of zinc therapy in the management of acute diarrhoea in young children and will have profound programmatic and policy implications for scaling up zinc intervention in the community.

Conditions

  • Acute Watery Diarrhoea

Interventions

DRUG

ZINC

Sponsors & Collaborators

  • International Centre for Diarrhoeal Disease Research, Bangladesh

    lead OTHER

Principal Investigators

  • Dewan S Alam, PhD · ICDDR,B: Centre for Health and Population Research

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
1 Month
Max Age
59 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-02-28
Primary Completion
2006-05-31
Completion
2006-05-31

Countries

  • Bangladesh

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00325247 on ClinicalTrials.gov