Vitamin D Repletion in Coronary Artery Disease
The Effects of Vitamin D Repletion on Endothelial Function and Inflammation in Patients With Coronary Artery Disease
Vitamin D (Vit D) status is an emerging risk marker of great interest in cardiovascular disease (CVD). Lower serum levels of Vit D are associated with both cardiac risk factors and prevalent cardiovascular disease. Vit D insufficiency remains very prevalent in free living populations in the United States especially in urban, and multi-ethnic low income Northern cities.To date, prospective randomized trials using Vit D supplementation to modify CVD risk and evaluate outcomes have not been performed.
The investigators propose a double-blind, randomized wait-list control trial in subjects with Coronary Artery Disease (CAD) and Vit D deficiency with two specific aims. Specific aim 1 is to measure endothelial function using reactive hyperemia peripheral arterial tonometry (RH-PAT) before and after treatment with Vit D replacement therapy. Specific Aim 2 is to measure levels of inflammation before and after treatment with Vit D replacement therapy. These aims will test the hypotheses that Vit D repletion will improve endothelial function and reduce the levels of detectable inflammation in the plasma of these subjects.
調査の概要
詳細な説明
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
-
-
New York
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Bronx、New York、アメリカ、10461
- Jacobi Medical Center
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Bronx、New York、アメリカ、10461
- Montefiore Medical Center / Weiler division
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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:
- Male and nonpregnant females greater than 18 years of age
- ≥ 50% angiographic stenosis of at least 1 coronary artery or documented previous revascularization
- Serum 25-hydroxyvitamin D < 20 ng/ml
Exclusion Criteria:
- confinement to a nursing facility, institution or home
- GFR < 60 ml/min (by MDRD equation)
- presence of liver disease
- hypercalcemia
- NYHA class III or IV heart failure
- cardiogenic shock at time of presentation
- current planned or emergent CABG
- prior gastric or small bowel surgery
- pancreatitis
- malabsorption
- inflammatory bowel disease
- autoimmune disease
- active malignancy
- current use of > 800 IU/day of vitamin D
- Current use of dilantin, phenobarbitol, immunosuppressant, or immunostimulant therapy
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：処理
- 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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プラセボコンパレーター：シュガーピル
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Oral capsule, once a week, 12 weeks
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アクティブコンパレータ：Ergocalciferol
50,000 units of ergocalciferol once a week for 12 weeks
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Oral capsule, 50,000 units, once a week, 12 weeks
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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 |
|---|---|---|
|
Endothelial Function
時間枠：Baseline and 12 weeks
|
Endothelial function was measured using peripheral arterial tonometry expressed as the reactive hyperemia index.
The index is derived from the ratio of the post-to-pre occlusion peripheral arterial tonometry signal amplitude of the tested arm, divided by the post -to-pre occlusion ratio of the control arm.
Median within subject change in endothelial function as measured by reactive hyperemia peripheral arterial tonometry index in each group is presented.
|
Baseline and 12 weeks
|
|
Inflammation -
時間枠：Baseline and 12 weeks
|
Median within subject change in hs-CRP levels between baseline and week 12 in active and placebo groups
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Baseline and 12 weeks
|
|
Inflammation
時間枠：Baseline to 12 weeks
|
Median within subject change in interferon-gamma levels between baseline and week 12 in active and placebo groups
|
Baseline to 12 weeks
|
|
Inflammation
時間枠：Baseline to 12 weeks
|
Median within subject change in cxcl-10 .levels between baseline and week 12 in active and placebo groups
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Baseline to 12 weeks
|
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Inflammation
時間枠：Baseline to week 12
|
Median within subject change in IL-12 levels between baseline and week 12 in active and placebo groups
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Baseline to week 12
|
協力者と研究者
スポンサー
協力者
捜査官
- 主任研究者：Seth I Sokol, MD、Jacobi Medical Center
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
本研究に関する用語
キーワード
追加の関連 MeSH 用語
その他の研究ID番号
- AHA Award #0885041N
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。