Efficacy of Zinc Therapy in Acute Diarrhoea in Young Children
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|ClinicalTrials.gov Identifier: NCT00325247|
Recruitment Status : Completed
First Posted : May 12, 2006
Last Update Posted : July 12, 2011
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.
|Condition or disease||Intervention/treatment||Phase|
|Acute Watery Diarrhoea||Drug: ZINC||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||2050 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Efficacy of Short Course Zinc Therapy (5 vs 10 d) With 20 mg Elemental Zinc Daily in the Treatment of Acute Diarrhoea: A Double-blind Individually Randomized Controlled Community Trial.|
|Study Start Date :||February 2005|
|Actual Primary Completion Date :||May 2006|
|Actual Study Completion Date :||May 2006|
- Preventive effect of zinc therapy on diarrhoea during the subsequent three month 14 days of enrollment
- Assess the acceptability of zinc therapy during diarrhoea in young children.
- Compare the duration of current episode in two groups receiving 5 d vs 10 d zinc.
- Compare the proportion of children developing prolonged (>10 d) or persistent diarrheoa (>14 d).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00325247
|Dhaka, Bangladesh, 1000|
|Principal Investigator:||Dewan S Alam, PhD||ICDDR,B: Centre for Health and Population Research|