University of Kentucky
Lexington, Kentucky, 40506, United States
NCT Number: NCT01488227
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.
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Notify Me18 year and older
All sexes
Interventional
Phase 3
Lexington, Kentucky, 40506, United States
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
4000 IU of Vitamin D daily for 6 months
Other names: Vitamin D by Nature Made by Pharmavite LLC
Acts as a control for the Vitamin D intervention
Other names: Placebo by Nature Made by Pharmavite LLC
Time frame: 3 measurement periods over 6 months
Baseline, Midpoint, and Endpoint measures include a blood draw for 25(OH)D status.
Time frame: Baseline and Enpoint
Baselineand Endpoint measures include a blood draw inflammatory cytokines (TNF alpha, IL1-B, IL6)
Time frame: Baseline, Midpoint, Endpoint
Baseline, Midpoint, and Endpoint measures include a blood draw for bone turnover markers (BSAP, NTx).
Time frame: Baseline and Endpoint
Baseline and Endpoint measures include Body Composition measures (DXA) for fat, muscle and bone composition
Time frame: Baseline, Midpoint, Endpoint
Baseline, Midpoint, and Endpoint measures include a behavioral survey for estimating 25(OH)D status (solar exposure, food and other supplemental intake)
Time frame: 6 months
We will track injury and illness type and incidence over the course of the 6 month intervention
University of Kentucky
Other
A Prospective Trial on the Effects of Vitamin D Supplementation on 25(OH)D, Body Composition and Injury in Collegiate Swimmers and Divers
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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