Efficacy of Use of Zinc in the Treatment of Acute Diarrhea in Infants Under Six Months.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 52
- 试验地点
- 1
- 主要终点
- duration of diarrheal episode
研究概览
简要总结
The purpose of this study is to determine the effect of zinc in acute watery diarrhea in children. The investigators will evaluate the effect of product versus placebo.
详细描述
Background: Acute Gastroenteritis is one of the most and frequent disease in the childhood, today exist strong evidence of beneficial effect of use of zinc in acute diarrhea in children over 6 months. but there are not enough clinical trials to show this beneficial effect on children under 6 months.
Objectives: To evaluate the effect of zinc in the treatment of children under 6 months age with acute diarrhea.
Methods: A randomized clinical trial, controlled, double-blind. The investigators will have two groups of patients : One group will receive zinc plus oral rehydration and the other one will receive placebo plus oral rehydration; the parameters of evaluation are going to be the duration of diarrheal episode, number of diarrhea stools by day, weight of stool, nutritional state.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 1 Month 至 6 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •all acute diarrhea
排除标准
- •Severe malnourishment
- •Severe dehydration
- •Systemic infections
- •coinfections
研究组 & 干预措施
zinc sulfate
zinc sulphate solution.
干预措施: Zinc Sulfate (Drug)
cornstarch solution
cornstarch powder diluted in distilled water
干预措施: placebo (Other)
结局指标
主要结局
duration of diarrheal episode
时间窗: five days
duration of diarreal episode, time in wich the watery stools will be normalized, an expected average of 5 days.
次要结局
- duration of hospitalization(5 days)
- weight of stool(5 days)
研究者
Giuseppe Grandy
Medical Chief of Nutrition Center
Centro Pediatrico Albina de Patino