Ignite Creation Date:
2024-05-05 @ 11:50 AM
Last Modification Date:
2024-10-26 @ 9:14 AM
Study NCT ID:
NCT00148733
Status:
COMPLETED
Last Update Posted:
2022-03-16
First Post:
2005-09-06
Brief Title:
CHIZAP Community- and Health Facility-Based Intervention With Zinc as Adjuvant Therapy for Childhood Pneumonia
Sponsor:
Centre For International Health
Organization:
Centre For International Health
Study Overview
Official Title:
Community- and Health Facility-based Intervention With Zinc as Adjuvant Therapy for Pneumonia to Enhance Child Health and Nutrition
Status:
COMPLETED
Status Verified Date:
2022-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
Detailed Description:
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 andor 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NUFU PRO 362002 | OTHER_GRANT | NUFU | None |
| 003740Eur Comm INCO | OTHER_GRANT | None | None |