Diarrhea Clinical Trial
Official title:
An Effectiveness Trial Examining the Addition of Zinc to the Current Case Management Package of Diarrhoea in a Primary Health Care Setting. Phase I
Verified date | July 2008 |
Source | Society for Applied Studies |
Contact | n/a |
Is FDA regulated | No |
Health authority | India: Ministry of Health |
Study type | Interventional |
Use of zinc in diarrhea may be an effective intervention to reduce hospitalizations and
child mortality as it could reach the most vulnerable children in a community and reduce
severity of not only diarrhea but also of associated infections. It might also potentially
reduce antibiotic use.
We conducted a pilot study prior to conducting a community based controlled effectiveness
trial to assess whether addition of zinc as a therapeutic modality for diarrhea delivered
through existing channels, reduces visits to health care providers, antibiotic and other
drug use, and increases ORS use during diarrhea.
Status | Completed |
Enrollment | 2364 |
Est. completion date | August 2004 |
Est. primary completion date | August 2004 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 1 Month to 5 Years |
Eligibility |
Inclusion Criteria: - Children aged 1 month to 5 years with diarrhea Exclusion Criteria: - Illness requiring hospitalization (referral) |
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
India | Society for Applied Studies | New Delhi | Delhi |
Lead Sponsor | Collaborator |
---|---|
Society for Applied Studies | Johns Hopkins University, World Health Organization |
India,
Bhandari N, Mazumder S, Taneja S, Dube B, Black RE, Fontaine O, Mahalanabis D, Bhan MK. A pilot test of the addition of zinc to the current case management package of diarrhea in a primary health care setting. J Pediatr Gastroenterol Nutr. 2005 Nov;41(5): — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | - Reduction in antibiotics and other drugs use during diarrheal illnesses | August 2003 to August 2004 | No | |
Primary | - Increase in ORS use during diarrhea | August 2003 to August 2004 | No | |
Primary | - Reduction in hospitalizations; all cause and diarrhea related | August 2003 to August 2004 | No |
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