跳至主要内容
临床试验/NCT00278746
NCT00278746已完成不适用

An Effectiveness Trial Examining the Addition of Zinc to the Current Case Management Package of Diarrhea in a Primary Health Care Setting.

Society for Applied Studies1 个研究点 分布在 1 个国家目标入组 20,032 人开始时间: 2005年1月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
20,032
试验地点
1
主要终点
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

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
1 Month 至 5 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Children aged 1 month to 5 years with diarrhea

排除标准

  • Illness requiring referral to hospital

研究组 & 干预措施

1

Experimental

Zinc and ORS were promoted for treatment of diarrhea in underfive children

干预措施: Zinc and ORS (Drug)

2

Other

Promoted routine management of diarrhea in underfive with ORS

干预措施: ORS only (Drug)

结局指标

主要结局

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

时间窗: 20 months (Jan 2005 to Sep 2006)

- Reduction in drug use; antibiotics and other drugs during diarrheal illnesses

时间窗: 20 months (Jan 2005 to Sep 2006)

- Increase in ORS use during diarrhea in the intervention communities.

时间窗: 20 months (Jan 2005 to Sep 2006)

- Reduction in visits to health care providers for treatment of illness

时间窗: 20 months (Jan 2005 to Sep 2006)

次要结局

  • - Reduction in all cause hospitalizations(20 months (Jan 2005 to Sep 2006))

研究者

申办方类型
Other

研究点 (1)

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