Effect of Zinc Sulphate and Zinc Amino Acid Chelate in Prevention Acute Diarrhea and Acute Respiratory Infection, Medellín 2012
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 360
- 试验地点
- 1
- 主要终点
- Incidence acute diarrheal disease and acute respiratory infection
研究概览
简要总结
Acute respiratory infection and acute diarrhea are among the most prevalent diseases of childhood increase the burden of morbidity and mortality in children under 5 years.
Among the possible strategies for its prevention is important to count on good nutritional status for use in developing a good immune response to infections. Zinc deficiency has been shown to favor the development of infections and has been considered a real public health problem.
Within the zinc compounds used are zinc amino acid chelate and zinc sulphate, the first that has shown evidence of being better absorbed and tolerated.
We propose a study showing the effectiveness of zinc amino acid chelate and zinc sulphate in the prevention of acute diarrheal disease and acute respiratory infection.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 2 Years 至 5 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Children who
- •Belong to institute FAN in Medellín
- •Attend full time to institute FAN (eight hours)
- •Have 2 to 5 years
排除标准
- •Children who
- •Children at the began of the study are with acute diarrheal disease and acute respiratory infection.
- •Recurrent pneumonia, cystic fibrosis, gastrointestinal malformations, persistent diarrhea of any cause, inflammatory bowel disease.
- •Failure to attend the educational institution for more than 10 days
- •No consumption of zinc supplementation for more than 10 days, because of insistence to the school
结局指标
主要结局
Incidence acute diarrheal disease and acute respiratory infection
时间窗: Up to 16 weeks
Preschool children will drink fortified milk with zinc amino acid chelate, zinc sulfate or milk without fortification. Fortnightly monitoring will be investigating the presence of infection (acute diarrheal disease and respiratory infections). Supervision and monitoring will be carried out for four months.
次要结局
- Adverse reaction(Fortnightly. During 4 months of intervention)
研究者
Juliana Sanchez,MG
Principal investigator
CES University