Efficiency and Safety of Zinc Sulphate to Reduce the Duration of Acute Diarrheal Disease Between 6 and 59 Months of Age
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 529
- 试验地点
- 18
- 主要终点
- Stool frequency
研究概览
简要总结
This study evaluates the effect of zinc over the duration, severity and relapse of acute diarrheic disease, in children between 6 and 59 months of age. One study group will receive a tablet that contains 20 mg of zinc, and the other study group will receive a tablet,that does not contain zinc, it is a tablet that investigators will use as control.
详细描述
In Mexico acute diarrheal diseases mortality in children continues to be a public health issue, being between the main causes of morbidity and mortality, with an important load for the health systems. Consequently, there exists a necessity for the implementation of alternate strategies for this condition, nutrition being one of the pillars to strengthen.
Zinc administration during the diarrhea episode is a simple intervention for clinical picture reduction and relapse. The recommendation of including zinc in the treatment of ADD is not part of the Mexican normativity. The evaluation of the efficacy of zinc administration in Mexican children is insufficient and a program or national strategy for zinc treatment does not exist.
The objective of this study is evaluates the efficacy of oral zinc sulfate administration, during the diarrhea clinic picture in children of Mexico City.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 6 Months 至 59 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Both sexes
- •Children attended in the sentinel centers
- •Clinical diagnosis of acute diarrhea disease
- •Parents have not planned moving to other location in a time period of at least one year.
排除标准
- •Deficient intestinal absorption syndrome
- •Acrodermatitis enterohepatic
- •Zinc sulfate hypersensitivity
- •Leucine metabolic disorders
- •Secondary lactose intolerance
- •Galactosemia lactase primary deficiency
- •Allergy to cow milk protein
- •Children that are supplemented with zinc for the last 6 months
研究组 & 干预措施
Placebo
Placebo tablet, once a day for 10 days
干预措施: Placebo (Dietary Supplement)
Zinc sulfate
Zinc sulfate 20 mg by mouth, once a day for 10 days
干预措施: zinc sulfate (Dietary Supplement)
结局指标
主要结局
Stool frequency
时间窗: 10 days
Number of stools during during the acute diarrheic disease
Diarrhea duration
时间窗: 10 days
Number of hours from the inclusion of the patient until the end of the diarrhea. The end of diarrhea was defined as the last diarrhea evacuation followed by a 48 hr period without diarrhea
次要结局
- zinc serum concentration(3, 9, 20, 31, 61, 91 and 121 days)
- diarrheic disease recurrence(3 and 6 months)
研究者
Jorge Salmeron Castro
Honorary researcher
Instituto Nacional de Salud Publica, Mexico