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临床试验/NCT02878265
NCT02878265已完成3 期

The Effect of Vitamin A With and Without Zinc and Multivitamin Supplementation on Malaria Morbidity in Ghanaian Children

University of Ghana1 个研究点 分布在 1 个国家目标入组 547 人开始时间: 2011年11月1日最近更新:
适应症
干预措施

试验速览

阶段
3 期
状态
已完成
入组人数
547
试验地点
1
主要终点
Incidence of clinical malaria attacks

研究概览

简要总结

The aim of this study was to determine the effect of combining vitamin A (VA), zinc (Z) and multivitamins (MV- A, B1, B2, B6, B12, C, D and E) on malaria morbidity

详细描述

A total of 542 children aged between 6-59 months received either: (i) VA (control) or (ii) VA & Z (VAZ) or (iii) VA, Z & MV (VAZM). VA was delivered as a single dose while MV and Z were delivered daily. Malaria cases were managed by community health workers, who used rapid diagnostic test to confirm infection prior to treatment.

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
None

入排标准

性别
Female
接受健康志愿者
否

入选标准

  • •under 5years
  • •will stay in the community for 10years

排除标准

  • •chronic diseases

研究组 & 干预措施

Vitamin A and zinc

Active Comparator

A single dose of 20,000IU Vitamin A and 10mg of elemental zinc each day for 5 months

干预措施: Vitamin A and ZInc (Dietary Supplement)

Vitamin A , Zinc and Multivitamin

Active Comparator

A single dose of 20,000IU Vitamin A , 10mg of elemental zinc each day and 0.5ml/kg multivitamin syrup for 5 months

干预措施: Vitamin A , Zinc and Multivitamin (Dietary Supplement)

Vitamin A

Placebo Comparator

A single dose of 20,000IU Vitamin A for the whole study period

干预措施: Vitamin A (Dietary Supplement)

结局指标

主要结局

Incidence of clinical malaria attacks

时间窗: Baseline and every month up to six months

While taking the supplement, malaria incidence will be measured

次要结局

  • Incidence of diarrhea attacks(Every month up to six months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Wilhelmina Annie Mensah

Ms

University of Ghana

研究点 (1)

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