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临床试验/NCT00459485
NCT00459485已完成4 期

Effects of Initiation and Discontinuation of Short Term Zinc Supplementation on the Magnitude and Velocity of Change in Plasma Zinc Concentration

University of California, Davis0 个研究点目标入组 58 人开始时间: 2007年4月最近更新:
适应症

试验速览

阶段
4 期
状态
已完成
入组人数
58
主要终点
Plasma zinc concentration

研究概览

简要总结

This is a double-blind, randomized controlled trial conducted in men 19-65 years of age who will receive daily zinc supplements (10 or 20 mg zinc/d as zinc sulfate) or placebo for 21 days. Blood samples for plasma zinc and CRP concentrations will be drawn at baseline and days 1, 2, 5, 9, 14, and 21 during supplementation and days 1, 2, 5, 9, and 14 after discontinuation of supplementation.

详细描述

The study will be a double blind, randomized, placebo controlled trial conducted in men 19-65 years of age. Participants will receive daily zinc or placebo liquid supplements for 21 days. Supplemental zinc will be given as zinc sulfate; the lower dose zinc supplement will contain 10 mg/d elemental zinc, and the higher dose zinc supplement will contain 20 mg/d elemental zinc. The placebo will contain the same excipients expect for zinc sulfate.

Multiple blood draws will be performed throughout the course of the study, to determine the responsiveness of plasma zinc concentrations to zinc supplementation. Two baseline blood draws will occur prior to the start of supplementation (study days -7 and 0). Blood draws will be performed on days 1, 2, 5, 9, 14 and 21 of the 21 day supplementation period. Upon termination of supplementation (day 21), blood draws will be performed on days 1, 2, 5, 9, 14 and 21 post-supplementation (study days 22, 23, 26, 30, 35 and 42).

The major outcomes of interest are the magnitude and velocity of change in plasma zinc concentration. Other outcomes to be assessed are plasma concentrations of the acute phase proteins CRP and AGP, as well as reported morbidity, because of their potential roles as confounding variables. Anthropometric variables will be assessed at baseline.

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
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
19 Years 至 65 Years(Adult, Older Adult)
性别
Male
接受健康志愿者

入选标准

  • Generally health men
  • 19-65 years
  • Non-anemic

排除标准

  • Age <19 or >65
  • Hemoglobin <120 g/L
  • Clinical evidence of illness
  • Consumption of mineral supplements
  • Recent blood donation (within 8 weeks)

结局指标

主要结局

Plasma zinc concentration

时间窗: 3 weeks

次要结局

未报告次要终点

研究者

申办方类型
Other

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