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Sponsors and Collaborators: |
Centre For International Health Tribuhwan University, Institute of Medicine, Department of Child Health, Nepal Statens Serum Institut All India Institute of Medical Sciences, New Delhi IRD, Epidemiologie et Prevention, Montpelier, France Society for Applied Studies |
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Information provided by: | Centre For International Health |
ClinicalTrials.gov Identifier: | NCT00148733 |
The aim of the study described is to measure the degree with which zinc given as adjunct therapy to standard antibiotic treatment during childhood pneumonia reduces the risk of treatment failure and the duration of the illness.
Condition | Intervention | Phase |
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Pneumonia |
Drug: Zinc |
Phase II Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study |
Official Title: | Community- and Health Facility-Based Intervention With Zinc as Adjuvant Therapy for Pneumonia to Enhance Child Health and Nutrition |
Enrollment: | 2628 |
Study Start Date: | January 2004 |
Study Completion Date: | January 2008 |
Primary Completion Date: | January 2008 (Final data collection date for primary outcome measure) |
Hypothesis: Zinc deficiency is a major public health problem in developing counties. Poor zinc status is associated with stunted growth and reduced resistance to infections. Several in vitro experiments and in vivo studies in animals and humans have demonstrated detrimental effects of zinc depletion on almost all facets of the immune system. The epithelial linings in the gut and in the respiratory tract are important for the resistance to infections and continuous cell division is required for proper function of these barriers. Zinc is crucial for cellular division and for the maintenance of organs with cells with a rapid turnover, including epithelial cells. Clinical trials in children in developing countries have demonstrated improved growth and reduced prevalence of diarrhea and respiratory tract infections following zinc supplementation. Furthermore, zinc has a well-documented therapeutic effect when given during acute or persistent diarrhea. The effect of zinc may be explained by correction of a deficiency state and/or by a pharmacological, as yet poorly described, action.
Due to the promising results from previous studies, WHO are now supporting large clinical trials in Nepal, India and Tanzania to assess whether routine zinc supplementation reduces mortality in early childhood. If the results of these trials show a mortality reduction, routine zinc supplementation or zinc dense foods may be promoted. However, while the first approach is logistically difficult and expensive, the second approach is difficult because zinc dense foods and foods with low phytic acid content are expensive and not readily available. Moreover, both approaches may be perceived to be incompatible with the current breast-feeding recommendations for the youngest children in most developing countries.
There is limited information on zinc as adjunct therapy for pneumonia. A recent hospital-based study in young children with severe pneumonia, showed that the zinc group had a faster recovery, resulting in a shortening of stay in hospital of one day. However, this study was small and no community based study has been conducted so far. Whether zinc has an effect during respiratory infections has to be assessed in studies with larger sample sizes in children with less severe disease and should be repeated in children with more severe disease. Short-term zinc administration during infections may become an alternative or an addition to long-term supplementation or promotion of zinc dense foods. Furthermore, therapeutic administration of zinc will not interfere with the current breast-feeding recommendations.
Hypothesis: Zinc as adjunct therapy for pneumonia may lead to faster recovery. Furthermore, long-term beneficial effects may include improved immuno-nutritional status measured by thymus size, less morbidity and improved growth.
Comparison: Duration of illness, risk of treatment failure, for those with severe pneumonia: length of hospital stay. Number of non-injury clinic visits and hospitalizations during the intervention with Zinc and an in a 6 month period after enrolment. Growth assessed by anthropometry and thymus size assessed by ultrasonography. Explore the efficacy of zinc in etiology-sub groups including those defined by nutritional status, inflammation, fever, gender, breastfeeding status and viral etiology.
Ages Eligible for Study: | 2 Months to 3 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Severe pneumonia: Child presenting with cough or difficult breathing and chest indrawing , but without any of the following danger signs:
Exclusion Criteria:
Nepal | |
Siddhi Memorial Hospital (SMH),Bhelukhel, Bhimsensthan | |
Bhaktapur, Nepal, P.O.Box 40 |
Study Director: | Tor A Strand, MD PhD | Centre for International Health, University of Bergen, 5021 Bergen, Norway |
Study Chair: | Halvor Sommerfelt, MD PhD | Centre for International Health, University of Bergen, 5021 Bergen, Norway |
Study Director: | Prakash S Shrestha, MD Professor | Child Health Research Project, Department of Child Health, Institute of Medicine, Maharajganj |
Study Chair: | Ramesh K Adhikari, MD Dean | Child Health Research Project, Department of Child Health, Institute of Medicine, Maharajganj |
Principal Investigator: | Palle Valentiner-Branth, MD PhD | Department of Epidemiology Research, Statens Serum Institut, 2300 Copenhagen S, Denmark |
Study ID Numbers: | 003740, 003740(Eur. Comm. INCO), NUFU PRO 36/2002 |
Study First Received: | September 6, 2005 |
Last Updated: | February 28, 2008 |
ClinicalTrials.gov Identifier: | NCT00148733 |
Health Authority: | Norway: The National Committees for Research Ethics in Norway |
Child pneumonia Zinc clinical trial |
Nepal nutrition therapeutic |
Respiratory Tract Infections Respiratory Tract Diseases Lung Diseases Zinc Pneumonia |
Growth Substances Physiological Effects of Drugs Trace Elements Micronutrients Pharmacologic Actions |