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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00278681
Recruitment Status : Completed
First Posted : January 18, 2006
Last Update Posted : July 2, 2008
Johns Hopkins University
World Health Organization
Information provided by:
Society for Applied Studies

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.

Condition or disease Intervention/treatment Phase
Diarrhea Hospitalization Drug: Zinc and ORS Phase 1

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2364 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Study Start Date : August 2003
Actual Primary Completion Date : August 2004
Actual Study Completion Date : August 2004

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diarrhea

Arm Intervention/treatment
Experimental: I
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.

Primary Outcome Measures :
  1. - Reduction in antibiotics and other drugs use during diarrheal illnesses [ Time Frame: August 2003 to August 2004 ]
  2. - Increase in ORS use during diarrhea [ Time Frame: August 2003 to August 2004 ]
  3. - Reduction in hospitalizations; all cause and diarrhea related [ Time Frame: August 2003 to August 2004 ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   1 Month to 5 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Children aged 1 month to 5 years with diarrhea

Exclusion Criteria:

  • Illness requiring hospitalization (referral)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00278681

Society for Applied Studies
New Delhi, Delhi, India, 110017
Sponsors and Collaborators
Society for Applied Studies
Johns Hopkins University
World Health Organization
Principal Investigator: Nita Bhandari, PhD Society for Applied Studies

Publications of Results:
Responsible Party: Nita Bhandari, Society for Applied Studies, New Delhi Identifier: NCT00278681     History of Changes
Other Study ID Numbers: HRN-A-96-90006-00
First Posted: January 18, 2006    Key Record Dates
Last Update Posted: July 2, 2008
Last Verified: July 2008

Keywords provided by Society for Applied Studies:

Additional relevant MeSH terms:
Signs and Symptoms, Digestive
Signs and Symptoms
Trace Elements
Growth Substances
Physiological Effects of Drugs