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

Vitamin D Deficiency Clinical Trial

Official title:

Vitamin D Deficiency in the Elder Patients of General Departments and Its Treatment During the Hospitalization

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00640237
• Other study ID #: VD-1.CTIL
• Status: Recruiting
• Phase: Phase 3
• First received: March 16, 2008
• Last updated: March 20, 2008
• Start date: March 2008
• Est. completion date: August 2008

Study information

• Verified date: March 2008
• Source: Rambam Health Care Campus
• Contact: Ish-Shalom Sofia, Professor
• Phone: 0502061099
• Email: s_ish_shalom[@]rambam.health.gov.il
• Is FDA regulated: No
• Health authority: Israel: Israeli Health Ministry Pharmaceutical Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: August 2008
• Est. primary completion date: July 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 65 Years and older

Eligibility

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

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Vitamin D Deficiency

Intervention

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.

Locations

Country	Name	City	State
Israel	Rambam Health Care Campus	Haifa

Sponsors (1)

Lead Sponsor	Collaborator
Rambam Health Care Campus

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	vitamin D status		two month	Yes
Secondary	physical performance, health conditions, arm strength, gait and balance state.		two month	Yes