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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of Kentucky
ClinicalTrials.gov Identifier:
NCT01488227
First received: November 29, 2011
Last updated: February 22, 2013
Last verified: February 2013
  Purpose

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.


Condition Intervention Phase
Healthy
Dietary Supplement: Vitamin D
Dietary Supplement: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Official Title: A Prospective Trial on the Effects of Vitamin D Supplementation on 25(OH)D, Body Composition and Injury in Collegiate Swimmers and Divers

Resource links provided by NLM:


Further study details as provided by University of Kentucky:

Primary Outcome Measures:
  • 25(OH)D) [ Time Frame: 3 measurement periods over 6 months ] [ Designated as safety issue: No ]
    Baseline, Midpoint, and Endpoint measures include a blood draw for 25(OH)D status.


Secondary Outcome Measures:
  • Inflammatory Cytokines [ Time Frame: Baseline and Enpoint ] [ Designated as safety issue: No ]
    Baselineand Endpoint measures include a blood draw inflammatory cytokines (TNF alpha, IL1-B, IL6)

  • Bone Turnover Markers [ Time Frame: Baseline, Midpoint, Endpoint ] [ Designated as safety issue: No ]
    Baseline, Midpoint, and Endpoint measures include a blood draw for bone turnover markers (BSAP, NTx).

  • DXA Body Composition [ Time Frame: Baseline and Endpoint ] [ Designated as safety issue: No ]
    Baseline and Endpoint measures include Body Composition measures (DXA) for fat, muscle and bone composition

  • Vitamin D Lifestyle Survey [ Time Frame: Baseline, Midpoint, Endpoint ] [ Designated as safety issue: No ]
    Baseline, Midpoint, and Endpoint measures include a behavioral survey for estimating 25(OH)D status (solar exposure, food and other supplemental intake)

  • injury and illness incidence [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    We will track injury and illness type and incidence over the course of the 6 month intervention


Enrollment: 45
Study Start Date: August 2011
Study Completion Date: March 2012
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Vitamin D
Vitamin D
Dietary Supplement: Vitamin D
4000 IU of Vitamin D daily for 6 months
Other Name: Vitamin D by Nature Made by Pharmavite LLC
Placebo Comparator: Oil pill
Contains vegetable and soybean oil supplied by Nature Made by Pharmavite LLC located in Northridge, CA and is United States Pharmacopeia (USP) certified.
Dietary Supplement: Placebo
Acts as a control for the Vitamin D intervention
Other Name: Placebo by Nature Made by Pharmavite LLC

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01488227

Locations
United States, Kentucky
University of Kentucky
Lexington, Kentucky, United States, 40506
Sponsors and Collaborators
University of Kentucky
Investigators
Study Director: Maja Redzic, B.S. University of Kentucky
Study Director: Regina M Lewis, B.S. University of Kentucky
Principal Investigator: David T Thomas, PhD University of Kentucky
  More Information

No publications provided

Responsible Party: University of Kentucky
ClinicalTrials.gov Identifier: NCT01488227     History of Changes
Other Study ID Numbers: UL1RR033173
Study First Received: November 29, 2011
Last Updated: February 22, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of Kentucky:
Vitamin D status in athletes
Vitamin D
25(OH)D
athletes
body composition
inflammatory markers
illness
injury

Additional relevant MeSH terms:
Vitamin D
Ergocalciferols
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Bone Density Conservation Agents

ClinicalTrials.gov processed this record on August 01, 2014