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

Rambam Health Care Campus

Status and phase: Unknown; Phase 3

Conditions: Vitamin D Deficiency

Treatments: Dietary Supplement: Alpha-D3

Study type: Interventional

Funder types: Other

Identifiers

NCT00640237

VD-1.CTIL

Details and patient eligibility

About

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.

Full 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.

Enrollment: 300 estimated patients

Sex: All

Ages: 65+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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300 participants in 2 patient groups

1

Experimental group

Description:

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

Treatment:

Dietary Supplement: Alpha-D3

2

No Intervention group

Description:

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.