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.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Inscription (Réel)
Phase
- Phase 3
Contacts et emplacements
Lieux d'étude
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Kentucky
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Lexington, Kentucky, États-Unis, 40506
- University of Kentucky
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
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.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Quadruple
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
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Expérimental: Vitamin D
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4000 IU of Vitamin D daily for 6 months
Autres noms:
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Comparateur placebo: 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
Autres noms:
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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25(OH)D)
Délai: 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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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Inflammatory Cytokines
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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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Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Directeur d'études: Maja Redzic, B.S., University of Kentucky
- Directeur d'études: Regina M Lewis, B.S., University of Kentucky
- Chercheur principal: David T Thomas, PhD, University of Kentucky
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- UL1RR033173 (Subvention/contrat des NIH des États-Unis)
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