A Prospective Trial on the Effects of Vitamin D Supplementation on 25(OH)D, Body Composition and Injury in Collegiate Swimmers and Divers
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 45
- 试验地点
- 2
- 主要终点
- 25(OH)D)
研究概览
简要总结
Objective 1: Determine if Vitamin D supplementation can improve body composition, reduce injuries and illnesses, and improve performance in collegiate swimmers and divers.
Objective 2: Examine how baseline Vitamin D levels predict outcome variables over the course of the intervention period.
详细描述
The investigators plan to recruit from approximately 45 male and female University of Kentucky Swimmers and Divers, at least 18 years of age in August 2011. Approximately equal numbers of men and women will be recruited. The entire athletic team(s) will be recruited. With a conservative dropout rate of 30%, the investigators final sample size should be approximately 22 participants (per group).Following baseline measures, participants will be randomized to one of two groups (Vitamin D 4000 IU or Placebo control) and monitored over the course of their athletic season. Measurements will be repeated at Midpoint (3 months) and Endpoint (6 months).
Participants will have no recent history of Vitamin D supplementation beyond what is normally found in a multivitamin (400 IUs).
Following the informed consent process a medical history and Vitamin D questionnaire (screenings), and urine pregnancy test (for female athletes) will be administered prior to more invasive baseline testing procedures (blood draw and DXA). A blood draw will then be conducted at baseline, midpoint and endpoint. Collected blood for the purposes of this study will assess Vitamin D status (25(OH)D), parathyroid hormone, ionized calcium, bone turnover markers, and inflammatory cytokines. A Vitamin D lifestyle questionnaire will be administered at all 3 time points and incidence of illness and injury will be documented over 6 months following randomization. DXA measures will only occur at Baseline and Endpoint.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •University of Kentucky Swimmers and Divers, at least 18 years old.
- •No recent history of Vitamin D supplementation beyond 400IU
排除标准
- •hormone replacement therapy,
- •high dose Vitamin D supplementation,
- •history of renal disease or kidney stones,
- •organ transplantation,
- •sarcoidosis,
- •parathyroid disease,
- •history of high blood calcium levels.
结局指标
主要结局
25(OH)D)
时间窗: 3 measurement periods over 6 months
Baseline, Midpoint, and Endpoint measures include a blood draw for 25(OH)D status.
次要结局
- Inflammatory Cytokines(Baseline and Enpoint)
- Bone Turnover Markers(Baseline, Midpoint, Endpoint)
- DXA Body Composition(Baseline and Endpoint)
- Vitamin D Lifestyle Survey(Baseline, Midpoint, Endpoint)
- injury and illness incidence(6 months)