The Effect of Vitamin D Statues on Endothelial Function (CVD Cookie)
In the United States, cardiovascular disease causes over one-third of all deaths and vitamin D deficiency is an epidemic. An increasing body of data suggests that low vitamin D status adversely impacts the cardiovascular system. It is our fundamental hypothesis that vitamin D deficiency is a risk factor for cardiovascular disease by causing endothelial dysfunction. Moreover, we hypothesize that vitamin D supplementation will restore endothelial function, thereby reducing cardiovascular disease risk.
This pilot research will be conducted in 64 post-menopausal women participating in an existing study of vitamin D supplementation (32 will receive vitamin D3 2,500 IU daily, the others matching placebo) and will explore the effects of vitamin D on endothelial function and arterial reactivity. Post-menopausal women aged 55-65 years are chosen due to their highest risk for development of a subsequent new cardiovascular disease diagnosis. All study participants will have fasting laboratory and noninvasive vascular ultrasound studies performed at baseline and four months later. The primary outcome measure of this pilot study is change in markers of endothelial function and arterial stiffness with vitamin D3 therapy. If our hypotheses are correct, our long-term goals include investigation of the effect of vitamin D repletion on subclinical atherosclerosis and subsequent cardiovascular events.
調査の概要
研究の種類
入学 (予想される)
段階
- 初期フェーズ 1
連絡先と場所
研究場所
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Wisconsin
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Madison、Wisconsin、アメリカ、53705
- University of Wisconsin Osteoporosis Clinical and Research Program
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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:
- Healthy, community-dwelling ambulatory post-menopausal women.
- Able and willing to sign informed consent.
- Ages: 55-65.
- Baseline serum 25OHD concentration > 10 ng/ml and < 60 ng/ml
- Not pregnant
- Willing to avoid use of cod-liver oil and non-study vitamin D supplementation; standard multiple vitamins containing ≤ 400 IU used no more than once daily will be allowed.
- Willing to utilize sunscreen of SPF-15 or higher when sun exposure for more than 15 minutes is expected.
- Willing to fast for 12 hours.
Exclusion Criteria:
- Current hypercalcemia (serum calcium > 10.5 mg/dl) or untreated primary hyperparathyroidism.
- History of nephrolithiasis
- Baseline 24-hour urine calcium > 250 mg
- Known risk factors for hypercalcemia, e.g., malignancy, tuberculosis, sarcoidosis, Paget's disease.
- History of any form of cancer within the past five years with the exception of adequately treated squamous cell or basal cell skin carcinoma.
- Known previous personal history of cardiovascular disease.
- Renal failure; defined as a calculated creatinine clearance (using the Cockroft-Gault approach) of ≤ 25 ml/minute.
- Severe end-organ disease, e.g., cardiovascular, hepatic, hematologic, pulmonary, etc., which might limit the ability to complete this study.
- Treatment with any drug known to interfere with vitamin D metabolism, e.g., phenytoin, phenobarbital.
- Known malabsorption syndromes, e.g., celiac disease, active inflammatory bowel disease, etc.
- Known allergy to chocolate.
- Use of medications known to alter bone turnover including bisphosphonates, estrogen, selective estrogen receptor modulators, parathyroid hormone, testosterone or calcitonin.
- Treatment with any active metabolites of vitamin D, e.g., calcitriol, within six months of screening.
- Use of tanning beds or salons or unwillingness to utilize sunscreen during periods of sun exposure of 15 minutes or longer.
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
- 主な目的:防止
- 割り当て:ランダム化
- 介入モデル:単一グループの割り当て
- マスキング:ダブル
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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プラセボコンパレーター:Control
This group receives placebo chocolate cookies with no vitamin D3 added.
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No (0 IU) vitamin D3 added to cookie.
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実験的:Vitamin D3
This group receives 2500 IU of Vitamin D3 added to a chocolate cookie daily.
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2500 IU Vitamin D3
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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 |
時間枠 |
|---|---|
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The primary outcome measure of this pilot study is change in markers of endothelial function and arterial stiffness with vitamin D3 therapy.
時間枠:17 months
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17 months
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協力者と研究者
捜査官
- 主任研究者:Rekha Ramamurthy, M.D.、University of Wisconsin Osteoporosis Clinical Center and Research Program
- スタディディレクター:Neil C Binkley, M.D.、University of Wisconsin Osteoporosis Clinical Center and Research Program
出版物と役立つリンク
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
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。
Placeboの臨床試験
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Shanghai Hengrui Pharmaceutical Co., Ltd.完了
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Consano Bio募集坐骨神経痛 | 坐骨神経根症 | 腰仙神経根症 | 腰仙神経根症候群 | 腰仙部神経根痛 | 坐骨神経痛オーストラリア
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Palacky University完了
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Universidade Federal do ParaConselho Nacional de Desenvolvimento Científico e Tecnológico完了