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临床试验/NCT00396500
NCT00396500已完成3 期

To Assess the Effectiveness of Six-Monthly Deworming With Vitamin A Administration on Growth in 1-5 Year Old Children in the Urban Slums of Lucknow

King George's Medical University2 个研究点 分布在 1 个国家目标入组 4,000 人开始时间: 1994年4月最近更新:
适应症
相关药物

试验速览

阶段
3 期
状态
已完成
入组人数
4,000
试验地点
2
主要终点
Change in weight in 2 years

研究概览

简要总结

Background. More than a third of the world's population is infected with intestinal nematodes. A majority of these infections occur in children. Current control approaches emphasise treatment of school age children, and there is a lack of information on the effects of deworming preschool childrenSetting: Within the Integrated Child Development System (ICDS) infrastructure in urban Lucknow (UP), IndiaDesign: Open Labeled randomised trialHypothesis: Our study hypothesis was that albendazole administration six monthly, as a single 400 mg dose in syrup, by the existing health care delivery system would be a practicable way to achieve mass deworming of preschool children and this might result in an improvement in weight gain of preschool childrenIntervention One group will receive usual health care by the existing health care staff, which included six monthly administration of Vitamin A concentrate. The other group will receive, in addition, 400 mg of albendazole (Zentel, Smith Kline & Beecham) in 10 ml syrup form. Five such doses will be given at six monthly intervals for 2 years.Main objective: To assess the impact of 6 monthly deworming on weight and height gain at the end of 2 years in children aged 1 to 5 years of age Main outcomes measures: Weight gain in 2 yearsInclusion criteria: Children 1 to 5 years, whose guardians give written informed consent. Exclusion criteria: Those not consentingSample size: Sample size was calculated for a continuous outcome. For a standardized effect size of 0.1, with a power of 80% and an alpha level of 0.05, using a 2-tailed t test, taking into account design effect, about 2000 children will be included in each arm.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Single Group
主要目的
Health Services Research
盲法
None

入排标准

年龄范围
1 Year 至 5 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Local residents
  • Aged 1-5 years
  • Informed written parental consent

排除标准

  • Refusal to give consent
  • prior enrollment in the study

结局指标

主要结局

Change in weight in 2 years

次要结局

  • Secondary: Weight and Height gain in underweight, stunted and wasted children

研究者

申办方类型
Other

研究点 (2)

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Deworming and Vitamin A (DEVTA) Prepilot Study | 临床试验