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
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.
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
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.
Studietype
Inschrijving (Werkelijk)
Fase
- Fase 3
Contacten en locaties
Studie Locaties
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Kentucky
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Lexington, Kentucky, Verenigde Staten, 40506
- University of Kentucky
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
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.
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Verviervoudigen
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
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Experimenteel: Vitamin D
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4000 IU of Vitamin D daily for 6 months
Andere namen:
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Placebo-vergelijker: 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.
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Acts as a control for the Vitamin D intervention
Andere namen:
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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25(OH)D)
Tijdsspanne: 3 measurement periods over 6 months
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Baseline, Midpoint, and Endpoint measures include a blood draw for 25(OH)D status.
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3 measurement periods over 6 months
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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Inflammatory Cytokines
Tijdsspanne: Baseline and Enpoint
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Baselineand Endpoint measures include a blood draw inflammatory cytokines (TNF alpha, IL1-B, IL6)
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Baseline and Enpoint
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Bone Turnover Markers
Tijdsspanne: Baseline, Midpoint, Endpoint
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Baseline, Midpoint, and Endpoint measures include a blood draw for bone turnover markers (BSAP, NTx).
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Baseline, Midpoint, Endpoint
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DXA Body Composition
Tijdsspanne: Baseline and Endpoint
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Baseline and Endpoint measures include Body Composition measures (DXA) for fat, muscle and bone composition
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Baseline and Endpoint
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Vitamin D Lifestyle Survey
Tijdsspanne: Baseline, Midpoint, Endpoint
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Baseline, Midpoint, and Endpoint measures include a behavioral survey for estimating 25(OH)D status (solar exposure, food and other supplemental intake)
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Baseline, Midpoint, Endpoint
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injury and illness incidence
Tijdsspanne: 6 months
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We will track injury and illness type and incidence over the course of the 6 month intervention
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6 months
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Medewerkers en onderzoekers
Sponsor
Onderzoekers
- Studie directeur: Maja Redzic, B.S., University of Kentucky
- Studie directeur: Regina M Lewis, B.S., University of Kentucky
- Hoofdonderzoeker: David T Thomas, PhD, University of Kentucky
Studie record data
Bestudeer belangrijke data
Studie start
Primaire voltooiing (Werkelijk)
Studie voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Schatting)
Updates van studierecords
Laatste update geplaatst (Schatting)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- UL1RR033173 (Subsidie/contract van de Amerikaanse NIH)
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