Clinical trial NCT00278746: Addition of Zinc to the Current Case Management Package of Diarrhea in a Primary Health Care Setting
Official title: An Effectiveness Trial Examining the Addition of Zinc to the Current Case Management Package of Diarrhea in a Primary Health Care Setting.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diarrhea
Mortality
Hospitalization
Keywords: zinc
diarrhea
cluster randomization
hospitalization
Lead sponsor: Society for Applied Studies
Sponsor class: OTHER
Collaborators: name: Ministry of Science and Technology, India
name: United Nations Children's Fund, Delhi
name: World Health Organization
First posted: 2006-01-18
Enrollment: 20032
Sex: ALL
Minimum age (years): 1
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

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 criteria: Inclusion Criteria:

* Children aged 1 month to 5 years with diarrhea

Exclusion Criteria:

* Illness requiring referral to hospital

Primary outcomes:
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
timeFrame: 20 months (Jan 2005 to Sep 2006)
measure: - Reduction in visits to health care providers for treatment of illness
timeFrame: 20 months (Jan 2005 to Sep 2006)
measure: - Reduction in drug use; antibiotics and other drugs during diarrheal illnesses
timeFrame: 20 months (Jan 2005 to Sep 2006)
measure: - Increase in ORS use during diarrhea in the intervention communities.
timeFrame: 20 months (Jan 2005 to Sep 2006)
Secondary outcomes:
measure: - Reduction in all cause hospitalizations
timeFrame: 20 months (Jan 2005 to Sep 2006)
Other outcomes:
Locations:
city: New Delhi
country: India
facility: Society for Applied Studies
state: Delhi
Study officials:
affiliation: Society for Applied Studies
name: Nita Bhandari, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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. doi: 10.1542/peds.2007-1939.