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Effectiveness of Adding Zinc to the Current Case Management Package of Diarrhea in a Primary Health Care Setting

This study has been completed.
Sponsor:
Collaborators:
Johns Hopkins University
World Health Organization
Information provided by:
Society for Applied Studies
ClinicalTrials.gov Identifier:
NCT00278681
First received: January 13, 2006
Last updated: July 1, 2008
Last verified: July 2008
History of Changes

January 13, 2006
July 1, 2008
August 2003
August 2004   (final data collection date for primary outcome measure)
  • - Reduction in antibiotics and other drugs use during diarrheal illnesses [ Time Frame: August 2003 to August 2004 ] [ Designated as safety issue: No ]
  • - Increase in ORS use during diarrhea [ Time Frame: August 2003 to August 2004 ] [ Designated as safety issue: No ]
  • - Reduction in hospitalizations; all cause and diarrhea related [ Time Frame: August 2003 to August 2004 ] [ Designated as safety issue: No ]
  • - Reduction in antibiotics and other drugs use during diarrheal illnesses
  • - Increase in ORS use during diarrhea
  • - Reduction in hospitalizations; all cause and diarrhea related
Complete list of historical versions of study NCT00278681 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
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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

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.

The pilot study was conducted in a primary health centre (population ~33000) in Faridabad district of the state of Haryana in India. Formative research identified perceptions of caregivers regarding childhood diarrhea, causation and management, care seeking sources and caregivers expectations from healthcare providers. Caregivers in households with children under 5 years old were interviewed in a cross sectional survey to ascertain family characteristics, ORS prescription and use rates, drug prescription rates by healthcare providers and other variables of interest.

In partnership with the local government, channels for distribution of zinc and ORS packets were defined. The channels included physicians (at PHC and private practitioners), auxiliary nurse midwives (ANMs) and Anganwadi workers (AWWs)of the Integrated Child Development Services (ICDS) scheme. Recommendations were developed and translated into local vernacular. A poster, which incorporated the recommendations and pictures of zinc strip and ORS packets, was designed. These posters were put up at different places in the study area. All channels were trained and provided with the supplies of zinc strips and ORS packets except the private practitioners who received only zinc strips and advised caregivers to take ORS packets from government channels. Effectiveness of this pilot program was assessed through 2 cross sectional surveys, 3 and 6 months post training.

The cross sectional surveys revealed that the prescription of syrups, tablets, powders and injections during diarrhea and cost of treatment decreased significantly. Prescription and use of ORS increased markedly. Zinc tablets were prescribed and used in about half the episodes 6 months after start of intervention. It was feasible to train various government and community channels to promote zinc as treatment of acute diarrhea through the primary health care system.
Interventional
Phase 1
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Diarrhea
  • Hospitalization
Drug: Zinc and ORS

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.
Experimental: I
Zinc and ORS
Intervention: Drug: Zinc and ORS
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
2364
August 2004
August 2004   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Children aged 1 month to 5 years with diarrhea

Exclusion Criteria:

  • Illness requiring hospitalization (referral)
Both
1 Month to 5 Years
No
Contact information is only displayed when the study is recruiting subjects
India
 
NCT00278681
HRN-A-96-90006-00, 77955
No
Nita Bhandari, Society for Applied Studies, New Delhi
Society for Applied Studies
  • Johns Hopkins University
  • World Health Organization
Principal Investigator: Nita Bhandari, PhD Society for Applied Studies
Society for Applied Studies
July 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP