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临床试验/NCT00394862
NCT00394862已完成不适用

Efficacy of Weekly Versus Daily Folic Acid Supplementation

Emory University0 个研究点目标入组 460 人开始时间: 2006年1月最近更新:
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试验速览

阶段
不适用
状态
已完成
入组人数
460
主要终点
serum folate level

研究概览

简要总结

Investigate the efficacy of weekly versus daily of folic acid supplementation on improving folate, vitamin B12,

详细描述

460 women of a rural community in the western highlands of Guatemala were recruited for participation in the double-blinded study led by Emory University and the Institute of Nutrition of Central America and Panama (INCAP). The women were randomly assigned one of 4 vitamin treatments containing different levels of folic acid, Vitamin B12, iron and zinc. The treatments were as follows:

  1. weekly dose of folic acid at 5000ug, iron at 120 mg, zinc at 30mg, and B12 at 16.8 ug;
  2. weekly dose of folic acid at 2800ug, iron at 120mg, zinc at 0mg and B12 at 16.8ug;
  3. daily dose of folic acid at 400ug, iron at 60mg, zinc at 15mg, B12 at 2.4ug; and
  4. daily dose of folic acid at 200ug, iron at 50mg, zinc at 0mg, and B12 at 2.4ug.

The women, aged 15-49, received the vitamins daily for 3 months. Anthropometric data and blood samples were taken at baseline and post-supplementation. The participants also completed a series of dietary interviews at baseline and post-intervention. No pregnant or lactating mothers were admitted into the study, nor severely anemic females. Blood samples were sent to the National Laboratory in Cuernavaca, Mexico, for analysis of serum folate levels.

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

入排标准

年龄范围
15 Years 至 49 Years(Child, Adult)
性别
Female
接受健康志愿者

入选标准

  • aged 15-49

排除标准

  • lactating less than 3 months
  • severely anemic

结局指标

主要结局

serum folate level

red blood cell folate

次要结局

  • depression
  • homocysteine
  • serum zinc
  • ferritin
  • blood pressure
  • serum B12

研究者

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

Dr. Reynaldo Martorell

Professor

Emory University

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