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

NCT ID: NCT00640237

Last Updated: 2008-03-21

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE3
• Total Enrollment: 300 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-03-31
• Study Completion Date: 2008-08-31

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.

Conditions

Vitamin D Deficiency

Keywords

Vitamine D State

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1

Arm 1 - the patients will receive two large doses of vitamin D.

Group Type: EXPERIMENTAL

Alpha-D3

Intervention Type: DIETARY_SUPPLEMENT

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.

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: DIETARY_SUPPLEMENT

Other Intervention Names

25(OH)-D3

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.

• Minimum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Rambam Health Care Campus

OTHER

Sponsor Role: lead

Responsible Party

The Chief of Unite for Bone Metabolism of Rambam Medical Center

Principal Investigators

Ish-Shalom Sofia, Professor

Role: PRINCIPAL_INVESTIGATOR

Rambam Health Care Campus

Locations

Rambam Health Care Campus

Haifa, , Israel

Site Status: RECRUITING

Countries

Israel

Central Contacts

Ish-Shalom Sofia, Professor

Role: CONTACT

Phone: 0502061099

Email: s_ish_shalom@rambam.health.gov.il

Nodelmam Marina, MD

Role: CONTACT

Email: mnodelman@gmail.com

Other Identifiers

VD-1.CTIL

Identifier Type: -

Identifier Source: org_study_id