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Completed

NCT Number: NCT00278681

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

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.

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Key information

Conditions

Diarrhea Hospitalization Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive

Age range

1 month–5 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Society for Applied Studies

New Delhi, National Capital Territory of Delhi, 110017, India

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Children aged 1 month to 5 years with diarrhea

Exclusion criteria

  • Illness requiring hospitalization (referral)

Treatment and study plan

Zinc and ORS

Drug

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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Society for Applied Studies

Other

Collaborators

  • Johns Hopkins University
  • World Health Organization

Registry information

Official study 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

Important dates

Study start
2003
Primary completion
2004
Study completion
2004
First posted
Jan 18, 2006
Registry last updated
Jul 2, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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