Trials / Completed
CompletedNCT01488227
A Prospective Trial on the Effects of Vitamin D Supplementation in Collegiate Swimmers and Divers
A Prospective Trial on the Effects of Vitamin D Supplementation on 25(OH)D, Body Composition and Injury in Collegiate Swimmers and Divers
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 45 (actual)
- Sponsor
- University of Kentucky · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Accepted
Summary
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.
Detailed description
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DIETARY_SUPPLEMENT | Vitamin D | 4000 IU of Vitamin D daily for 6 months |
| DIETARY_SUPPLEMENT | Placebo | Acts as a control for the Vitamin D intervention |
Timeline
- Start date
- 2011-08-01
- Primary completion
- 2012-03-01
- Completion
- 2012-03-01
- First posted
- 2011-12-08
- Last updated
- 2013-02-25
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT01488227. Inclusion in this directory is not an endorsement.