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.
調査の概要
詳細な説明
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.
研究の種類
入学 (実際)
段階
- フェーズ 3
連絡先と場所
研究場所
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Kentucky
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Lexington、Kentucky、アメリカ、40506
- University of Kentucky
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
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.
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：4倍
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：Vitamin D
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4000 IU of Vitamin D daily for 6 months
他の名前：
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プラセボコンパレーター：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
他の名前：
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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25(OH)D)
時間枠：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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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Inflammatory Cytokines
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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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協力者と研究者
スポンサー
捜査官
- スタディディレクター：Maja Redzic, B.S.、University of Kentucky
- スタディディレクター：Regina M Lewis, B.S.、University of Kentucky
- 主任研究者：David T Thomas, PhD、University of Kentucky
研究記録日
主要日程の研究
研究開始
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (見積もり)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- UL1RR033173 (米国 NIH グラント/契約)
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。
Vitamin Dの臨床試験
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