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临床试验/NCT00992823
NCT00992823已完成不适用

Iron Supplementation to Reduce Preschoolers Anemia: Comparison Between Intermittent and Cyclic Procedure

Sao Jose do Rio Preto Medical School1 个研究点 分布在 1 个国家目标入组 99 人开始时间: 2006年3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
发起方
入组人数
99
试验地点
1
主要终点
Initial and final blood hemoglobin concentration

研究概览

简要总结

Aim: To evaluate the efficacy of iron supplements given at intervals corresponding to the mean life of red blood cells compared to weekly supplementation, in reducing the prevalence of preschool anemia.

Method: Ninety-nine children from public day care centers with ages from 24 to 59 months old were randomly divided into two groups. All the children received 40 doses of 30 mg of ferrous sulfate during a 10-month intervention period. Group 1 received once weekly supplementation and Group 2 received supplementation in two 5-month cycles, each cycle consisting of one month of supplementation (20 workdays) and four months without supplementation.

详细描述

The prevalence of anemia after the supplementation regimens reduced from 20.20% to 5.05% (P < 0.0005); the reduction was not significantly different between the two groups (P = 0.35). The mean hemoglobin concentration increased in both groups (Group 1: 0.27 g/dL; P < 0.016 and Group 2: 0.47 g/dL; P < 0.0005) without significant differences between the groups (P = 0.17).

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
24 Months 至 59 Months(Child)
性别
All
接受健康志愿者

入选标准

  • The participants of the study were children with ages ranging from 24 to 59 months old that attended four local public day care centers

排除标准

  • Presence of infection or reported infections within two weeks prior to the intervention
  • Anemia lower than 7.0 g/dL and children taking medications containing ferrous sulfate

研究组 & 干预措施

Group 1:iron weekly supplementation

Active Comparator

干预措施: iron supplementation (Biological)

Group 2: cycle supplementation

Active Comparator

two 5-month cycles, each cycle consisting of one month of supplementation (20 workdays) and four months without supplementation.

干预措施: iron supplementation (Biological)

结局指标

主要结局

Initial and final blood hemoglobin concentration

时间窗: 10 months

次要结局

未报告次要终点

研究者

发起方
Sao Jose do Rio Preto Medical School
申办方类型
Other

研究点 (1)

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