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Completed

NCT Number: NCT01488227

A Prospective Trial on the Effects of Vitamin D Supplementation in Collegiate Swimmers and Divers

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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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

University of Kentucky

Lexington, Kentucky, 40506, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • University of Kentucky Swimmers and Divers, at least 18 years old.
  • No recent history of Vitamin D supplementation beyond 400IU

Exclusion criteria

  • 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.

Treatment and study plan

Vitamin D

Dietary Supplement

4000 IU of Vitamin D daily for 6 months

Other names: Vitamin D by Nature Made by Pharmavite LLC

Placebo

Dietary Supplement

Acts as a control for the Vitamin D intervention

Other names: Placebo by Nature Made by Pharmavite LLC

Primary outcomes

  1. 25(OH)D)

    Time frame: 3 measurement periods over 6 months

    Baseline, Midpoint, and Endpoint measures include a blood draw for 25(OH)D status.

Secondary outcomes

  1. Inflammatory Cytokines

    Time frame: Baseline and Enpoint

    Baselineand Endpoint measures include a blood draw inflammatory cytokines (TNF alpha, IL1-B, IL6)

  2. Bone Turnover Markers

    Time frame: Baseline, Midpoint, Endpoint

    Baseline, Midpoint, and Endpoint measures include a blood draw for bone turnover markers (BSAP, NTx).

  3. DXA Body Composition

    Time frame: Baseline and Endpoint

    Baseline and Endpoint measures include Body Composition measures (DXA) for fat, muscle and bone composition

  4. Vitamin D Lifestyle Survey

    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)

  5. injury and illness incidence

    Time frame: 6 months

    We will track injury and illness type and incidence over the course of the 6 month intervention

Sponsors and collaborators

Lead sponsor

University of Kentucky

Other

Registry information

Official study title

A Prospective Trial on the Effects of Vitamin D Supplementation on 25(OH)D, Body Composition and Injury in Collegiate Swimmers and Divers

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Dec 8, 2011
Registry last updated
Feb 25, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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