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

January 13, 2006
July 1, 2008
January 2005
September 2006   (final data collection date for primary outcome measure)
  • 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 ]
  • 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
  • - Reduction in visits to health care providers for treatment of illness
  • - Reduction in drug use; antibiotics and other drugs during diarrheal illnesses
  • - Increase in ORS use during diarrhea in the intervention communities.
Complete list of historical versions of study NCT00278746 on ClinicalTrials.gov Archive Site
- Reduction in all cause hospitalizations [ Time Frame: 20 months (Jan 2005 to Sep 2006) ] [ Designated as safety issue: No ]
  • - Reduction in all cause hospitalizations
  • - Reduction in all cause deaths
Not Provided
Not Provided
 
Addition of 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 Diarrhea in a Primary Health Care Setting.

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.

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.

Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Diarrhea
  • Mortality
  • Hospitalization
  • 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
  • Drug: ORS only
    In the control sites ORS alone was promoted
  • Experimental: 1
    Zinc and ORS
    Intervention: Drug: Zinc and ORS
  • No Intervention: 2
    ORS only
    Intervention: Drug: ORS only
Bhandari N, Mazumder S, Taneja S, Dube B, Agarwal RC, Mahalanabis D, Fontaine O, Black RE, Bhan MK. Effectiveness of zinc supplementation plus oral rehydration salts compared with oral rehydration salts alone as a treatment for acute diarrhea in a primary care setting: a cluster randomized trial. Pediatrics. 2008 May;121(5):e1279-85.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
20032
September 2006
September 2006   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Children aged 1 month to 5 years with diarrhea

Exclusion Criteria:

  • Illness requiring referral to hospital
Both
1 Month to 5 Years
No
Contact information is only displayed when the study is recruiting subjects
India
 
NCT00278746
PR-5268/PID/20/198/2004
No
Nita Bhandari, Society for Applied Studies, New Delhi
Society for Applied Studies
  • Ministry of Science and Technology, India
  • United Nations Children's Fund, New Delhi
  • 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