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

This study has been completed.
Sponsor:
Collaborators:
Ministry of Science and Technology, India
United Nations Children's Fund, New Delhi
World Health Organization
Information provided by:
Society for Applied Studies
ClinicalTrials.gov Identifier:
NCT00278746
First received: January 13, 2006
Last updated: July 1, 2008
Last verified: July 2008
  Purpose

Several studies have shown the beneficial effect of zinc treatment in acute diarrhea. There was a significant reduction in duration of the treated episodes and in their severity as measured by diarrheal stool output or frequency. Zinc is a potentially important immunomodulator or nutraceutical which may have great impact as therapeutic agent in conditions like diarrhea and pneumonia. The issue is whether and how zinc should be introduced in primary health care programs for treatment of acute diarrhea. A practical, sustainable intervention for introduction of zinc as treatment of acute diarrhoea in national programs is therefore required. This study aimed to address this issue.


Condition Intervention
Diarrhea
Mortality
Hospitalization
Drug: Zinc and ORS
Drug: ORS only

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Effectiveness Trial Examining the Addition of Zinc to the Current Case Management Package of Diarrhea in a Primary Health Care Setting.

Resource links provided by NLM:


Further study details as provided by Society for Applied Studies:

Primary Outcome Measures:
  • To evaluate in a community based controlled effectiveness trial whether addition of zinc as a therapeutic modality for diarrhea delivered through existing channels, including at village level to the current case management package for under-five children [ Time Frame: 20 months (Jan 2005 to Sep 2006) ] [ Designated as safety issue: No ]
  • - Reduction in visits to health care providers for treatment of illness [ Time Frame: 20 months (Jan 2005 to Sep 2006) ] [ Designated as safety issue: No ]
  • - Reduction in drug use; antibiotics and other drugs during diarrheal illnesses [ Time Frame: 20 months (Jan 2005 to Sep 2006) ] [ Designated as safety issue: No ]
  • - Increase in ORS use during diarrhea in the intervention communities. [ Time Frame: 20 months (Jan 2005 to Sep 2006) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • - Reduction in all cause hospitalizations [ Time Frame: 20 months (Jan 2005 to Sep 2006) ] [ Designated as safety issue: No ]

Enrollment: 20032
Study Start Date: January 2005
Study Completion Date: September 2006
Primary Completion Date: September 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Zinc and ORS
Drug: Zinc and ORS
Government and private providers and village health workers were trained to prescribe zinc and ORS for use in diarrheal episodes in 1 month to 5 years old children in intervention communities
No Intervention: 2
ORS only
Drug: ORS only
In the control sites ORS alone was promoted

Detailed Description:

This cluster randomized trial aimed at evaluating in a community based controlled effectiveness trial whether addition of 2RDA zinc as a therapeutic modality to the current case management package for diarrhoea in children aged between 1 month and 5 years, delivered through existing channels at village level, resulted in reduction in care seeking from health care providers, antibiotic and other drug use and increase in ORS use rates.

The intervention was being implemented in 6 PHCs; 3 intervention and 3 control.

Based on the experience of a pilot study and the formative research findings, common sources visited by caregivers for care seeking during morbidity were identified. These sources were selected as channels in partnership with the local government, to distribute zinc strips and ORS packets in intervention sites and only ORS packets in control sites. These channels were physicians (at the PHC and private practitioners), the auxiliary nurse midwives (ANMs) and Anganwadi workers (AWWs) of the Integrated Child Development Services (ICDS) Scheme. All the channels were trained and supplies of zinc strips and ORS packets, and ORS packets only were distributed in each pair of PHC in intervention and control sites respectively. Recommendations were developed and translated into local vernacular. A poster, incorporating these recommendations and pictures of zinc strips and ORS packets, was designed and put up at various places in the intervention sites. For outcome measurements, cross sectional surveys were conducted at 6 monthly intervals.

Process evaluation activities, which included observations of different channels and exit interviews with mothers after they had visited a channel were conducted.

In the two groups, zinc was used in 36.5% and 59.8% diarrheal episodes and ORS in 34.8% and 59.2% episodes in the 4 weeks preceding interviews in intervention areas. In control areas, ORS was used in 7.8% and 9.8% episodes. Care seeking for diarrhea, prescription of drugs of unknown identity and antibiotics for diarrhea reduced in intervention communities.

The study demonstrated that an intervention to improve diarrhea management with ORS and zinc is feasible and highly acceptable in rural Indian communities. The resulting health benefits were substantial and accomplished with a reduction in the cost to families for diarrhea treatment from current practices.

  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 referral to hospital
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00278746

Locations
India
Society for Applied Studies
New Delhi, Delhi, India, 110017
Sponsors and Collaborators
Society for Applied Studies
Ministry of Science and Technology, India
United Nations Children's Fund, New Delhi
World Health Organization
Investigators
Principal Investigator: Nita Bhandari, PhD Society for Applied Studies
  More Information

Publications:
Responsible Party: Nita Bhandari, Society for Applied Studies, New Delhi
ClinicalTrials.gov Identifier: NCT00278746     History of Changes
Other Study ID Numbers: PR-5268/PID/20/198/2004
Study First Received: January 13, 2006
Last Updated: July 1, 2008
Health Authority: India: Ministry of Health

Keywords provided by Society for Applied Studies:
zinc
diarrhea
cluster randomization
hospitalization

Additional relevant MeSH terms:
Diarrhea
Signs and Symptoms, Digestive
Signs and Symptoms
Zinc
Trace Elements
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 21, 2014