Effectiveness of Adding Zinc to the Current Case Management Package of Diarrhea in a Primary Health Care Setting
An Effectiveness Trial Examining the Addition of Zinc to the Current Case Management Package of Diarrhoea in a Primary Health Care Setting. Phase I
2 other identifiers
interventional
2,364
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Aug 2003
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2003
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2004
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2004
CompletedFirst Submitted
Initial submission to the registry
January 13, 2006
CompletedFirst Posted
Study publicly available on registry
January 18, 2006
CompletedJuly 2, 2008
July 1, 2008
1 year
January 13, 2006
July 1, 2008
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
- Reduction in antibiotics and other drugs use during diarrheal illnesses
August 2003 to August 2004
- Increase in ORS use during diarrhea
August 2003 to August 2004
- Reduction in hospitalizations; all cause and diarrhea related
August 2003 to August 2004
Study Arms (1)
I
EXPERIMENTALZinc and ORS
Interventions
One strip containing 14 dispersible zinc tablets (20 mg each) along with 2 ORS packets were prescribed to all children aged 1 month to 5 years visiting that channel with diarrhea. Infants aged less than 6 months were advised half a zinc tablet in a teaspoonful of breast milk; older children were advised 1 tablet in breast milk or clean water.
Eligibility Criteria
You may qualify if:
- Children aged 1 month to 5 years with diarrhea
You may not qualify if:
- Illness requiring hospitalization (referral)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Society for Applied Studieslead
- Johns Hopkins Universitycollaborator
- World Health Organizationcollaborator
Study Sites (1)
Society for Applied Studies
New Delhi, National Capital Territory of Delhi, 110017, India
Related Publications (1)
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):685-7. doi: 10.1097/01.mpg.0000182799.69675.92.
PMID: 16254536RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Nita Bhandari, PhD
Society for Applied Studies
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
January 13, 2006
First Posted
January 18, 2006
Study Start
August 1, 2003
Primary Completion
August 1, 2004
Study Completion
August 1, 2004
Last Updated
July 2, 2008
Record last verified: 2008-07