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Impact of Zinc Supplementation on Mortality and Hospitalizations in Children Aged 1 Months to 23 Months

2008年6月30日 更新者:Society for Applied Studies
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.

研究概览

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

介入性

注册 (实际的)

94359

阶段

  • 不适用

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

1个月 至 2年 (孩子)

接受健康志愿者

是的

有资格学习的性别

全部

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

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

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

在这里您可以找到参与这项研究的人员和组织。

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

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

2002年2月1日

初级完成 (实际的)

2003年3月1日

研究完成 (实际的)

2003年8月1日

研究注册日期

首次提交

2005年12月22日

首先提交符合 QC 标准的

2005年12月22日

首次发布 (估计)

2005年12月23日

研究记录更新

最后更新发布 (估计)

2008年7月1日

上次提交的符合 QC 标准的更新

2008年6月30日

最后验证

2008年6月1日

更多信息

与本研究相关的术语

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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