Clinical trial NCT00640237: Interventional Trial of Vitamin D Deficiency in the Patients of General Departments
Official title: Vitamin D Deficiency in the Elder Patients of General Departments and Its Treatment During the Hospitalization
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Vitamin D Deficiency
Keywords: Vitamine D State
Lead sponsor: Rambam Health Care Campus
Sponsor class: OTHER
First posted: 2008-03-21
Enrollment: 300
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to examine the vitamin D state of elder patients in therapeutic departments and to compere the treatment during the hospitalization with the out-patient treatment.

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: vitamin D status
timeFrame: two month
Secondary outcomes:
measure: physical performance, health conditions, arm strength, gait and balance state.
timeFrame: two month
Other outcomes:
Locations:
city: Haifa
country: Israel
facility: Rambam Health Care Campus
Study officials:
affiliation: Rambam Health Care Campus
name: Ish-Shalom Sofia, Professor
role: PRINCIPAL_INVESTIGATOR
References: