Clinical trial NCT00278681: Effectiveness of Adding 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 Diarrhoea in a Primary Health Care Setting. Phase I
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Diarrhea
Hospitalization
Keywords: zinc
diarrhea
hospitalization
programme
Lead sponsor: Society for Applied Studies
Sponsor class: OTHER
Collaborators: name: Johns Hopkins University
name: World Health Organization
First posted: 2006-01-18
Enrollment: 2364
Sex: ALL
Minimum age (years): 1
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: Inclusion Criteria:

* Children aged 1 month to 5 years with diarrhea

Exclusion Criteria:

* Illness requiring hospitalization (referral)

Primary outcomes:
measure: - Reduction in antibiotics and other drugs use during diarrheal illnesses
timeFrame: August 2003 to August 2004
measure: - Increase in ORS use during diarrhea
timeFrame: August 2003 to August 2004
measure: - Reduction in hospitalizations; all cause and diarrhea related
timeFrame: August 2003 to August 2004
Secondary outcomes:
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, Black RE, Fontaine O, Mahalanabis D, Bhan MK. A pilot test of the addition of zinc to the current case management package of diarrhea in a primary health care setting. J Pediatr Gastroenterol Nutr. 2005 Nov;41(5):685-7. doi: 10.1097/01.mpg.0000182799.69675.92.