The Effect of Daily Zinc Supplementation on Prevention of Diarrhea and Acute Respiratory Infections Among Children Less Than Five Years: A Randomized Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 140
- 试验地点
- 1
- 主要终点
- Change in the baseline cumulative incidence rate of diarrhea at 4 months
研究概览
简要总结
Zinc deficiency in children is a major problem which leads to compromised immunity and accordingly repeated infections. This study aims to investigate the effect of supplementing zinc to decrease the incidence of diarrhea and respiratory illness in children between 6 months and 5 years in Paediatric Outpatient Clinic in Ain Shams University Hospital.
详细描述
Zinc is a trace element that plays essential roles in protein and lipid metabolism, cell growth and differentiation, and the immune system; either cellular or humoral immunity. There is no specialized zinc storage system in the body, accordingly, a daily intake of zinc is required to maintain a steady state. Zinc deficiency can cause compromised immune function, accordingly this can lead to infections and growth defects among young children According to literature review search, there is lack of studies on the preventive effect of zinc supplementation on Egyptian children less than five years old; the age group which is known by the suboptimal nutritional status and the high prevalence of infection. Accordingly, the present study is aiming to evaluate the impact of 4 months of daily zinc supplementation on the incidence of diarrhea and respiratory illness and to detect the frequency of daily dietary intake of zinc-rich food children between 6 months and 5 years in Paediatric Outpatient Clinic in Ain Shams University Hospital.
Objectives:
- To evaluate the impact of 4 months of daily zinc supplementation on:
-
the incidence and the severity of diarrheal morbidity.
-
the incidence of acute respiratory infection.
- To measure the level of serum zinc in children between 6 months and 5 years attending Paediatric Outpatient Clinic in Ain Shams University Hospital.
- To compare between children who had initially low serum zinc level with those with normal level as regard the reduction in the incidence of diarrhea and respiratory illness.
- To measure the frequency of daily dietary intake of zinc-rich food in children between 6 months and 5 years attending Paediatric Outpatient Clinic in Ain Shams University Hospital.
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
- Single (Participant)
盲法说明
The study was single-blinded, where the children's mothers didn't know either their children are enrolled in the study group or the control group
入排标准
- 年龄范围
- 6 Months 至 5 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Apparently healthy child with good general health
排除标准
- •Children with severe malnutrition requiring hospital admission,
- •Cases of chronic and metabolic diseases as diabetic children
- •Children suffering from any type of cancer or any other debilitating disease.
研究组 & 干预措施
zinc group
The children were randomized to receive daily zinc sulphate. The elemental zinc dose was 3 mg/ day to children whose weight is less than 10 kg and 7 mg/ day to children whose weight is 10 kg or more.
干预措施: zinc (Dietary Supplement)
placebo group
The placebo was non-nutritious and vitamin-free, designed to be identical to the zinc syrup in colour, odour, consistency and taste. Zinc and placebo syrups were packaged in similar bottles.
干预措施: Placebo (Drug)
结局指标
主要结局
Change in the baseline cumulative incidence rate of diarrhea at 4 months
时间窗: after 4 months
Cumulative incidence rate of diarrhea at the baseline before intervention was compared to the cumulative incidence rate of diarrhea after 4 months of daily zinc supplements administration
Change in the baseline cumulative incidence rate of acute respiratory infections at 4 months
时间窗: after 4 months
Cumulative incidence rate of acute respiratory infections at the baseline before intervention was compared to the cumulative incidence rate of acute respiratory infections after 4 months of daily zinc supplements administration.
次要结局
未报告次要终点
研究者
Yosra Samir Abd El Ghaffar Souliman
Assistant lecturer of public health - Department of Community, Environmental and Occupational Medicine
Ain Shams University