Interventional Trial of Vitamin D Deficiency in the Patients of General Departments
Vitamin D Deficiency in the Elder Patients of General Departments and Its Treatment During the Hospitalization
調査の概要
詳細な説明
Today vitamin D is thought to be one of the most important vitamins in the human body. It's made in the skin during the sun expose, so it must be sufficient in so sunny countries as Israel. Although many old people in our country suffer from vitamin d deficiency which bring them to recurrent falls, osteoporotic fractures and physical disability. This problem is still underestimated by health authorities in different countries.
In this study we will examine the vitamin D state of the therapeutic patient older than 65 year including their physical self-estimation, muscle strength measurement and gait-and-balance tests. Then, according to the resent studies, we will treat the patients in the interventional group with two large doses of vitamin D during a month. After that we will compere their health and physical state with the patients treated in the out-hospital department.
So we will try to find a useful approach to treat the vitamin D deficiency during the hospitalization.
研究の種類
入学 (予想される)
段階
- フェーズ 3
連絡先と場所
研究場所
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-
-
Haifa、イスラエル
- 募集
- Rambam Health Care Campus
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副調査官：
- Nodelman Marina, MD
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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:
- the patient was admitted to a general department of Rambam Medical Center for any reason from March to May 2008
- the patient is 65 years old or older
- the patient is in a good health, based on medical history, physical examination and laboratory screening evaluation.
Exclusion Criteria:
- renal failure with creatinine level more then 1.3 mg/dL or nephritic syndrome.
- liver disease with transaminase rise three times from normal level.
- nephrolithiasis in the last fife years.
- primary hyperparathyroidism, hypoparathyroidism or pseudohypoparathyroidism.
- advanced cancer.
- chronic diarrhea or malabsorption.
- granulomatous disease (sarcoidosis, tuberculosis, lymphoma).
- patients, who are receiving barbiturates, rifampin, anticonvulsants.
- patients, who are receiving digitalis.
- patients, who are receiving glucocorticoids for more than two weeks during the study.
- advanced dementia.
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：非ランダム化
- 介入モデル：並列代入
- 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：1
Arm 1 - the patients will receive two large doses of vitamin D.
|
We will use the vitamin alpha-D3 drops of CTS pharmaceutical firm , that contains 5000 IU in ml.
Every patient in the interventional group will receive two dose of 100000 IU (20 ml)vitamin alpha-D3 within a month period.
他の名前：
|
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介入なし：2
Arm 2 - the patients vitamin D status will be checked during the hospitalization and they will receive the recommendation to treat the vitamin D deficiency in the out-patient department.
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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 |
|---|---|
|
vitamin D status
時間枠：two month
|
two month
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二次結果の測定
結果測定 |
時間枠 |
|---|---|
|
physical performance, health conditions, arm strength, gait and balance state.
時間枠：two month
|
two month
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協力者と研究者
捜査官
- 主任研究者：Ish-Shalom Sofia, Professor、Rambam Health Care Campus
研究記録日
主要日程の研究
研究開始
一次修了 (予想される)
研究の完了 (予想される)
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。