Impact of Zinc Supplementation on Mortality and Hospitalizations in Children Aged 1 Months to 23 Months
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 94,359
- 主要终点
- - 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,
研究概览
简要总结
Children, aged 1 months to 23 months, in the intervention households received zinc, iron and folic acid and those in the control households were administered iron and folic acid (IFA) alone for a period of one year. The primary outcomes were hospitalizations and deaths during this period.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 1 Month 至 35 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 1 months to 23 months
- •Either sex
- •Resident of study area
排除标准
- •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.
研究组 & 干预措施
1
干预措施: Zinc and iron folic acid - Intervention (Drug)
2
干预措施: Iron Folic Acid alone - Placebo (Drug)
结局指标
主要结局
- 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,
时间窗: 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.
时间窗: 3 monthly home visits
次要结局
- - the proportion of stunted or underweight children at end study(Baseline and end study after 12 months)
- - the proportion of zinc deficient (plasma zinc <60 mg/dl) children at end study(Baseline and end study after 12 months)
- - the mean plasma copper and superoxide dismutase at end study(Baseline and end study after 12 months)
- - the mean plasma ferritin and transferrin activity at end study(Baseline and end study after 12 months)