Pilot Study of Vitamin D Screening Use in Peripheral Arterial Disease Patient Over Maximum Distance Walking (First-BLINDOS)
Evaluation of a Strategy for Systematic Screening for Vitamin D Deficiency and Treatment in Case of Deficiency, on the Improvement of the Maximum Walking Distance in Patients With Stage 2 Lower Limb Arterial Disease.
The prevalence of peripheral arterial disease (PAD) is greater than 15%. PAD is associated with an increased risk of cardiovascular death, coronary heart disease and stroke, with a mortality rate of 5% per year.
Most clinical evidence supports the idea that having normal vitamin D reduces cardiovascular risk. The data suggests that normalizing vitamin D levels would have a significant impact on public health, reduce costs and help control the incidence and prevalence of cardiovascular disease.
There is also a plausible physiological theory, supported by numerous observational studies, that vitamin D supplementation should be effective in improving cardiovascular outcomes, such as blood pressure, arterial stiffness, atherosclerosis, endothelial function, and clinical events.
The investigators hypothesize that routine screening for vitamin D deficiency and supplementation in case of hypovitaminosis D is effective for improving the maximum walking distance after 12 weeks of treatment in stage 2 PAD patients .
調査の概要
詳細な説明
At admission eligible patients are proposed to participate. Written consent is signed after complete oral and written explanation of the protocol is signed. Vitamin D level will be assessed : Patients without vitamin D deficiency will be excluded.
The influence of vitamin D supplementation on the evolution of walking distance in 12 weeks will be studied by comparing the spontaneous evolution of this walking distance, in not supplemented patients (period 1 ), and the evolution under treatment with vitamin D (period 2, afer 3 months ).
The spontaneous evolution of the walking distance will be evaluated by the difference in walking distance observed between the beginning and the end of the first Period (3 months) . The evolution of walking distance under vitamin D treatment will be evaluated by the difference in walking distance between between the beginning and the end of the second Period (3 months).
The duration of participation for a subject is equal to 6 months (2 periods of 3 months )
研究の種類
入学 (実際)
段階
- フェーズ 4
連絡先と場所
研究場所
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-
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Angers、フランス、49933
- CHU Angers
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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:
- Patients presenting a Peripheral Arterial Disease (Stage 2)
- Affiliation to the French National healthcare system
- French speaking patients
Exclusion Criteria:
- Pregnancy
- Inability to understand the study goal
- Patients protected by decision of law
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：なし
- 介入モデル：単一グループの割り当て
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：Patients with Vitamin D deficiency
Patients with Vitamin D deficiency, Administration of Cholecalciferol 2.5 mg (100 000 UI), once a month for 3 months
|
Cholecalciferol 2.5mg (100 000 UI) , once a month for 3 months
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 |
|---|---|---|
|
Change of the maximum walking distance on treadmill
時間枠：baseline, 12 weeks and 24 weeks
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the Walking distance will be assessed during a test on a treadmill according to a standardized procedure
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baseline, 12 weeks and 24 weeks
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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 |
|---|---|---|
|
Tolerance of vitamin D supplementation during 12 weeks of treatment (period 2)
時間枠：24 weeks
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Prevalence and description of adverse events reported by the patient in a patient book and data collected at the end of treatment
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24 weeks
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Compliance with Vitamin D supplementation
時間枠：24 weeks
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Recording of vitamin D intake by the patient in a patient booklet and counting of the number of vitamin D boxes in the V2 visit
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24 weeks
|
協力者と研究者
捜査官
- 主任研究者：Samir HENNI, MD, PhD、University Hospital, Angers
研究記録日
主要日程の研究
研究開始 (実際)
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 (実際)
学習記録の更新
投稿された最後の更新 (実際)
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
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