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临床试验/NCT01328704
NCT01328704已完成不适用

Observational Study to Evaluate Changes in Iron, Vit-D, and CRP During a Twelve to Twenty-Four Week Supervised Triathlon Training Program

Avera McKennan Hospital & University Health Center1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2012年1月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
50
试验地点
1
主要终点
Iron level

研究概览

简要总结

The purpose of this study is to observe changes in iron status and vitamin D status during a 12-24 week supervised training program, specifically males and females between the ages of 30 and 50 years old.

详细描述

Study subjects will be participants in a triathlon training program through the Avera Sports Institute in Sioux Falls, SD. This clinical study will examine changes in iron and vitamin D levels. Blood specimens will be collected at baseline and again after 3 and 6 months of participating in the training program.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
30 Years 至 50 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Males and premenopausal females between the ages of 30 and 50 years old
  • Training through the Avera Sports Institute Triathlon Training Program
  • Agree to keep diet, exercise and all current health habits stable during participation in the study

排除标准

  • Women who are pregnant, breastfeeding or planning to become pregnant
  • Has a chronic disease that affects calcium or bone metabolism
  • Has a chronic disease that affects iron metabolism or iron storage
  • Has kidney disease
  • Has any laboratory or biometric value that would indicate an issue for the safety of the study subject
  • Is currently participating in another clinical research study

结局指标

主要结局

Iron level

时间窗: baseline, 3 months, 6 months

Serum iron levels

Vitamin D level

时间窗: Baseline, 3 months, 6 months

Serum Vitamin D 25(OH)D levels

C-Reactive Protein level

时间窗: Baseline, 3 months, 6 months

Serum C-reactive protein level

次要结局

  • Hemoglobin level(Baseline, 3 months, 6 months)
  • Ferritin level(Baseline, 3 months, 6 months)
  • Hematocrit(Baseline, 3 months, 6 months)
  • Total Iron Binding Capacity level(Baseline, 3 months, 6 months)

研究者

发起方
Avera McKennan Hospital & University Health Center
申办方类型
Other
责任方
Sponsor

研究点 (1)

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