Interventional Trial of Vitamin D Deficiency in the Patients of General Departments
Recruitment status was: Recruiting
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Vitamin D Deficiency in the Elder Patients of General Departments and Its Treatment During the Hospitalization|
- vitamin D status [ Time Frame: two month ] [ Designated as safety issue: Yes ]
- physical performance, health conditions, arm strength, gait and balance state. [ Time Frame: two month ] [ Designated as safety issue: Yes ]
|Study Start Date:||March 2008|
|Estimated Study Completion Date:||August 2008|
|Estimated Primary Completion Date:||July 2008 (Final data collection date for primary outcome measure)|
Arm 1 - the patients will receive two large doses of vitamin D.
Dietary Supplement: Alpha-D3
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.
Other Name: 25(OH)-D3
No Intervention: 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.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00640237
|Rambam Health Care Campus|
|Principal Investigator:||Ish-Shalom Sofia, Professor||Rambam Health Care Campus|