Impact of Zinc Supplementation on Mortality and Hospitalizations in Children Aged 1 Months to 23 Months
研究概览
地位
详细说明
Objective: Studies in developing countries show substantial reduction in diarrhoea and respiratory morbidity in young children receiving zinc supplementation. The impact of daily zinc supplementation coadministered with iron folic acid in young children on all cause hospitalisation and mortality in comparison with iron folic acid alone, was evaluated to help shape public policy.
Design: Randomised double blind trial
Setting: Low to middle socio-economic urban neighbourhoods of north and north-west Delhi in India
Participants: 94359 subjects aged 1 month to 23 months
Interventions: The subjects were administered dispersible tablets containing one recommended daily allowance of zinc and iron folic acid or iron folic acid alone, daily for 12 months after enrolment.
Main outcome measures: Hospitalisations were captured through passive surveillance of eight hospitals by trained study physicians. Deaths were ascertained through bimonthly visits to households.
Results: A third of the total children had low zinc levels (<60 mg/dL) and one fourth had iron deficiency (haematocrit <33%) at baseline. The proportion zinc deficient was significantly lower post 12 months supplementation, in the zinc and iron folic acid group (difference in proportions -10%; 95% confidence interval -15.6% to -4.4%, p 0.0005). Only 7.7% in the zinc and iron folic acid and 7.3% in the iron folic acid group had low haematocrit. Zinc and iron folic acid supplementation had no impact on hospitalisations, overall and cause-specific. The overall death rates were similar in the two groups.
Conclusions: The lack of mortality impact may be real or the findings could have resulted from the use of lower daily zinc dosing than in morbidity prevention trials or an interaction between zinc and iron whereby adding iron, may have adversely affected potential effects of zinc on immune function and morbidity. Future research should address iron and zinc interaction effects on important functional outcomes.
研究类型
注册 (实际的)
阶段
- 不适用
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Age 1 months to 23 months
- Either sex
- Resident of study area
Exclusion Criteria:
- Likely to leave the area during the study period
- Non consent
- Temporary exclusion criteria Illness requiring hospitalization Visible severe wasting. Visibly wasted children will be referred to a hospital for treatment. They will be eligible for enrollment only after effective rehabilitation.
学习计划
研究是如何设计的?
设计细节
- 主要用途:预防
- 分配:随机化
- 介入模型:阶乘赋值
- 屏蔽:四人间
武器和干预
参与者组/臂 |
干预/治疗 |
---|---|
实验性的:1个
|
The intervention group tablet contained 10 mg of elemental zinc, 12.5 mg of iron and 50 micrograms of folic acid.
|
安慰剂比较:2个
|
The control group tablets were similar in composition, appearance and taste except it contained placebo for zinc.
|
研究衡量的是什么?
主要结果指标
结果测量 |
大体时间 |
---|---|
- to determine the impact of daily oral supplementation of zinc (5 mg per day to infants aged less than 6 months and 10 mg per day to older children) and iron folic acid to children aged 1-23 months for a period of upto 12 months on all-cause mortality,
大体时间:3 monthly home visits
|
3 monthly home visits
|
- to determine the impact of daily oral supplementation of zinc and iron folic acid to children 1-23 months for a period of upto 12 months on overall and diarrhea and pneumonia specific hospital admissions.
大体时间:3 monthly home visits
|
3 monthly home visits
|
次要结果测量
结果测量 |
大体时间 |
---|---|
- the proportion of stunted or underweight children at end study
大体时间:Baseline and end study after 12 months
|
Baseline and end study after 12 months
|
- the proportion of zinc deficient (plasma zinc <60 mg/dl) children at end study
大体时间:Baseline and end study after 12 months
|
Baseline and end study after 12 months
|
- the mean plasma copper and superoxide dismutase at end study
大体时间:Baseline and end study after 12 months
|
Baseline and end study after 12 months
|
- the mean plasma ferritin and transferrin activity at end study
大体时间:Baseline and end study after 12 months
|
Baseline and end study after 12 months
|
合作者和调查者
调查人员
- 首席研究员:Nita Bhandari, PhD、Society for Applied Studies, New Delhi
- 首席研究员:Maharaj K Bhan, MD、Professor, Department of Pediatrics, All India Institute of Medical Sciences
出版物和有用的链接
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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