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临床试验/NCT00936091
NCT00936091已完成不适用

Effects of Vitamin A Supplementation on Intestinal Parasitic Reinfections, Growth, Iron Status and Educational Achievement Among Orang Asli Schoolchildren in Pos Betau, Pahang, Malaysia

Sana'a University1 个研究点 分布在 1 个国家目标入组 250 人开始时间: 2007年5月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
250
试验地点
1
主要终点
intestinal parasitic infections

研究概览

简要总结

Intestinal parasitic infections, malnutrition and iron deficiency anaemia (IDA) are still considered as public health problems in rural Malaysia especially among Orang Asli children. Despite intermittent control programmes, the prevalence of these problems is still high suggesting the need of other control and interventions measures. This randomized double-blind, placebo-controlled trial was carried out among Orang Asli schoolchildren from Sekolah Kebangsaan Betau in Pos Betau, Pahang (200 km northeast Kuala Lumpur) to investigate the effects of vitamin A supplementation on intestinal parasitic reinfections, growth, iron status and educational achievement.

HYPOTHESES

  1. Vitamin A supplementation has a negative effect on intestinal parasitic reinfections and the worm burden of infections among Orang Asli schoolchildren in Pos Betau, Kuala Lipis, Pahang.
  2. Vitamin A supplementation has a positive effect on growth (weight and height) among Orang Asli schoolchildren.
  3. Vitamin A supplementation is effective in improving serum iron status among Orang Asli schoolchildren.
  4. Vitamin A supplementation has a positive effect on cognitive function and educational achievement among Orang Asli schoolchildren.

详细描述

Children from Sekolah Kebangsaan Betau in Pos Betau, Kuala Lipis, Pahang served as the target population for this study.

The selection criteria for study subjects were the following:

  • Age 7-12 years (according to birth date in birth certificate).
  • Non-menstruating females (age <13)
  • No history or evidence of underlying haematological-related diseases such as thalassaemia and ovalocytosis.
  • No evidence of concomitant severe and/or chronic illness such as acute respiratory tract infections, mental retardation and neurological deficits.
  • Consent of parent to participate in the study.

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
Double (Participant, Investigator)

入排标准

年龄范围
7 Years 至 12 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Age 7-12 years (according to birth date in birth certificate).
  • No evidence of concomitant severe and/or chronic illness such as acute respiratory tract infections, mental retardation and neurological deficits.
  • Consent of parent to participate in the study.

排除标准

  • history or evidence of underlying haematological-related diseases such as thalassaemia and ovalocytosis.
  • menstruating females (age >13)

研究组 & 干预措施

placebo

Placebo Comparator

125 schoolchildren were allocated randomly to receive placebo

干预措施: Placebo (Drug)

vitamin A supplement

Active Comparator

125 children received vitamin A supplements capsules (200 000 IU)

干预措施: vitamin A supplements (Drug)

结局指标

主要结局

intestinal parasitic infections

时间窗: 6 months

次要结局

  • growth , iron status & educational achievement(6 months)

研究者

申办方类型
Other

研究点 (1)

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