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
研究概览
详细说明
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.
研究类型
注册 (预期的)
阶段
- 第三阶段
联系人和位置
学习地点
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-
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Haifa、以色列
- 招聘中
- Rambam Health Care Campus
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副研究员：
- Nodelman Marina, MD
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
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.
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：非随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：1
Arm 1 - the patients will receive two large doses of vitamin D.
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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.
其他名称：
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无干预：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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研究衡量的是什么？
主要结果指标
结果测量 |
大体时间 |
|---|---|
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vitamin D status
大体时间：two month
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two month
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次要结果测量
结果测量 |
大体时间 |
|---|---|
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physical performance, health conditions, arm strength, gait and balance state.
大体时间：two month
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two month
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合作者和调查者
调查人员
- 首席研究员：Ish-Shalom Sofia, Professor、Rambam Health Care Campus
研究记录日期
研究主要日期
学习开始
初级完成 (预期的)
研究完成 (预期的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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