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

Sponsors and Collaborators:	Society for Applied Studies Johns Hopkins University World Health Organization
Information provided by:	Society for Applied Studies
ClinicalTrials.gov Identifier:	NCT00278681

Purpose

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.

Condition	Intervention	Phase
Diarrhea Hospitalization	Drug: Zinc and ORS	Phase I

MedlinePlus related topics: Antibiotics Diarrhea

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Open Label, Uncontrolled, Single Group Assignment
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

Further study details as provided by Society for Applied Studies:

Primary Outcome Measures:

- 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 ]

Enrollment:	2364
Study Start Date:	August 2003
Study Completion Date:	August 2004
Primary Completion Date:	August 2004 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
I: Experimental Zinc and ORS	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.

Detailed Description:

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.

Eligibility

Ages Eligible for Study:	1 Month to 5 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Children aged 1 month to 5 years with diarrhea

Exclusion Criteria:

Illness requiring hospitalization (referral)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00278681

Locations

India, Delhi
Society for Applied Studies
New Delhi, Delhi, India, 110017

Sponsors and Collaborators

Society for Applied Studies

Johns Hopkins University

World Health Organization

Investigators

Principal Investigator:

Nita Bhandari, PhD

Society for Applied Studies

More Information

Publications of Results:

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.

Responsible Party:	Society for Applied Studies, New Delhi ( Nita Bhandari )
Study ID Numbers:	HRN-A-96-90006-00, 77955
Study First Received:	January 13, 2006
Last Updated:	July 1, 2008
ClinicalTrials.gov Identifier:	NCT00278681
Health Authority:	India: Ministry of Health

Keywords provided by Society for Applied Studies:

zinc
diarrhea
hospitalization
programme

Study placed in the following topic categories:

Signs and Symptoms
Diarrhea
Signs and Symptoms, Digestive
Zinc

Additional relevant MeSH terms:

Growth Substances
Physiological Effects of Drugs
Trace Elements
Micronutrients
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009