Interventional Trial of Vitamin D Deficiency in the Patients of General Departments - Full Text View

Sponsored by:	Rambam Health Care Campus
Information provided by:	Rambam Health Care Campus
ClinicalTrials.gov Identifier:	NCT00640237

Purpose

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.

Condition	Intervention	Phase
Vitamin D Deficiency	Dietary Supplement: Alpha-D3	Phase III

Drug Information available for: Vitamin E alpha-Tocopherol alpha-Tocopheryl acetate Tocopherols Vitamin D Ergocalciferol Alfacalcidol

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study
Official Title:	Vitamin D Deficiency in the Elder Patients of General Departments and Its Treatment During the Hospitalization

Further study details as provided by Rambam Health Care Campus:

Primary Outcome Measures:

vitamin D status [ Time Frame: two month ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

physical performance, health conditions, arm strength, gait and balance state. [ Time Frame: two month ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	300
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)

Arms	Assigned Interventions
1: Experimental 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.
2: No Intervention 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.

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.

Eligibility

Ages Eligible for Study:	65 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00640237

Contacts

Contact: Ish-Shalom Sofia, Professor	0502061099	s_ish_shalom@rambam.health.gov.il
Contact: Nodelmam Marina, MD		mnodelman@gmail.com

Locations

Israel
Rambam Health Care Campus	Recruiting
Haifa, Israel
Sub-Investigator: Nodelman Marina, MD

Sponsors and Collaborators

Rambam Health Care Campus

Investigators

Principal Investigator:

Ish-Shalom Sofia, Professor

Rambam Health Care Campus

More Information

Responsible Party:	The Chief of Unite for Bone Metabolism of Rambam Medical Center ( Professor Sofia Ish-Shalom )
Study ID Numbers:	VD-1.CTIL
Study First Received:	March 16, 2008
Last Updated:	March 20, 2008
ClinicalTrials.gov Identifier:	NCT00640237
Health Authority:	Israel: Israeli Health Ministry Pharmaceutical Administration

Keywords provided by Rambam Health Care Campus:

Vitamine D State

Study placed in the following topic categories:

Vitamin D Deficiency
Tocopherol acetate
Avitaminosis
1-hydroxycholecalciferol
Ergocalciferols
Hydroxycholecalciferols
Alpha-Tocopherol

Tocopherols
Vitamin E
Malnutrition
Vitamin D
Nutrition Disorders
Deficiency Diseases

ClinicalTrials.gov processed this record on January 14, 2009