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

Primary Purpose

Vitamin D Deficiency

Status
Unknown status
Phase
Phase 3
Locations
Israel
Study Type
Interventional
Intervention
Alpha-D3
Sponsored by
Rambam Health Care Campus
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Vitamin D Deficiency focused on measuring Vitamine D State

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Rambam Health Care CampusRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

1

2

Arm Description

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

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.

Outcomes

Primary Outcome Measures

vitamin D status

Secondary Outcome Measures

physical performance, health conditions, arm strength, gait and balance state.

Full Information

First Posted
March 16, 2008
Last Updated
March 20, 2008
Sponsor
Rambam Health Care Campus
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1. Study Identification

Unique Protocol Identification Number
NCT00640237
Brief Title
Interventional Trial of Vitamin D Deficiency in the Patients of General Departments
Official Title
Vitamin D Deficiency in the Elder Patients of General Departments and Its Treatment During the Hospitalization
Study Type
Interventional

2. Study Status

Record Verification Date
March 2008
Overall Recruitment Status
Unknown status
Study Start Date
March 2008 (undefined)
Primary Completion Date
July 2008 (Anticipated)
Study Completion Date
August 2008 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Rambam Health Care Campus

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vitamin D Deficiency
Keywords
Vitamine D State

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
300 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Arm 1 - the patients will receive two large doses of vitamin D.
Arm Title
2
Arm Type
No Intervention
Arm 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.
Intervention Type
Dietary Supplement
Intervention Name(s)
Alpha-D3
Other Intervention Name(s)
25(OH)-D3
Intervention Description
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.
Primary Outcome Measure Information:
Title
vitamin D status
Time Frame
two month
Secondary Outcome Measure Information:
Title
physical performance, health conditions, arm strength, gait and balance state.
Time Frame
two month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ish-Shalom Sofia, Professor
Phone
0502061099
Email
s_ish_shalom@rambam.health.gov.il
First Name & Middle Initial & Last Name or Official Title & Degree
Nodelmam Marina, MD
Email
mnodelman@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ish-Shalom Sofia, Professor
Organizational Affiliation
Rambam Health Care Campus
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rambam Health Care Campus
City
Haifa
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nodelman Marina, MD

12. IPD Sharing Statement

Learn more about this trial

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

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