Interventional Trial of Vitamin D Deficiency in the Patients of General Departments

Phase 3

• Conditions: Vitamin D Deficiency
• Interventions: Dietary Supplement: Alpha-D3

• Registration Number: NCT00640237
• Lead Sponsor: Rambam Health Care Campus

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.

Study Timeline

• Status Verified: 2008-03
• Study Start: 2008-03
• Study First Submitted: 2008-03-16
• Study First Submitted QC: 2008-03-20
• Last Update Submitted: 2008-03-20
• Study First Posted: 2008-03-21
• Last Update Posted: 2008-03-21
• Primary Completion: 2008-07
• Study Completion: 2008-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 300

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Alpha-D3	Arm 1 - the patients will receive two large doses of vitamin D.

Primary Outcome Measures

Name	Time	Method
vitamin D status	two month

Secondary Outcome Measures

Name	Time	Method
physical performance, health conditions, arm strength, gait and balance state.	two month

Trial Locations

Locations (1)

Rambam Health Care Campus; 🇮🇱 Haifa, Israel