Efficacy of Zinc Therapy in Acute Diarrhoea in Young Children
Status:
Completed
Trial end date:
2006-05-01
Target enrollment:
Participant gender:
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.
Phase:
Phase 3
Details
Lead Sponsor:
International Centre for Diarrhoeal Disease Research, Bangladesh