Society for Applied Studies
New Delhi, National Capital Territory of Delhi, 110017, India
NCT Number: NCT00278746
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.
Looking for future studies?
Notify Me1 month–5 year
All sexes
Interventional
Not applicable
New Delhi, National Capital Territory of Delhi, 110017, India
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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
Promoted routine management of diarrhea in underfive with ORS
Time frame: 20 months (Jan 2005 to Sep 2006)
Time frame: 20 months (Jan 2005 to Sep 2006)
Time frame: 20 months (Jan 2005 to Sep 2006)
Time frame: 20 months (Jan 2005 to Sep 2006)
Time frame: 20 months (Jan 2005 to Sep 2006)
Society for Applied Studies
Other
An Effectiveness Trial Examining the Addition of Zinc to the Current Case Management Package of Diarrhea in a Primary Health Care Setting.
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.
Published trials that share one or more normalized conditions with this study.
NCT00278681
Diarrhea, Hospitalization
New Delhi, National Capital Territory of Delhi, India
View Trial DetailsNCT00269542
Diarrhea, Infections
View Trial DetailsNCT02875249
Diarrhea, Pathological Conditions, Signs and Symptoms
Nantes, France
View Trial DetailsNCT06268717
Abdominal Pain, Alpha-Gal Syndrome
Chapel Hill, North Carolina, United States
View Trial Details