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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified March 2008 by Rambam Health Care Campus.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00640237
First Posted: March 21, 2008
Last Update Posted: March 21, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Rambam Health Care Campus
  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 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Vitamin D Deficiency in the Elder Patients of General Departments and Its Treatment During the Hospitalization

Resource links provided by NLM:


Further study details as provided by Rambam Health Care Campus:

Primary Outcome Measures:
  • vitamin D status [ Time Frame: two month ]

Secondary Outcome Measures:
  • physical performance, health conditions, arm strength, gait and balance state. [ Time Frame: two month ]

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
Experimental: 1
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.

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

Information from the National Library of Medicine

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Ages Eligible for Study:   65 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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: Professor Sofia Ish-Shalom, The Chief of Unite for Bone Metabolism of Rambam Medical Center
ClinicalTrials.gov Identifier: NCT00640237     History of Changes
Other Study ID Numbers: VD-1.CTIL
First Submitted: March 16, 2008
First Posted: March 21, 2008
Last Update Posted: March 21, 2008
Last Verified: March 2008

Keywords provided by Rambam Health Care Campus:
Vitamine D State

Additional relevant MeSH terms:
Vitamin D Deficiency
Avitaminosis
Deficiency Diseases
Malnutrition
Nutrition Disorders
Vitamins
Vitamin D
Ergocalciferols
Hydroxycholecalciferols
Alfacalcidol
Micronutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents