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

Vitamin D Deficiency in the Elder Patients of General Departments and Its Treatment During the Hospitalization

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.

Study Overview

• Status: Unknown
• Conditions: Vitamin D Deficiency
• Intervention / Treatment: Dietary supplement: Alpha-D3

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.

• Study Type: Interventional
• Enrollment (Anticipated): 300
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Ish-Shalom Sofia, Professor; Phone Number: 0502061099; Email: s_ish_shalom@rambam.health.gov.il
• Study Contact Backup: Name: Nodelmam Marina, MD; Email: mnodelman@gmail.com

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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 Names: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
vitamin D status	two month

Secondary Outcome Measures

Outcome Measure	Time Frame
physical performance, health conditions, arm strength, gait and balance state.	two month

Collaborators and Investigators

• Sponsor: Rambam Health Care Campus
• Investigators: Principal Investigator: Ish-Shalom Sofia, Professor, Rambam Health Care Campus

Study record dates

Study Major Dates

• Study Start: March 1, 2008
• Primary Completion (Anticipated): July 1, 2008
• Study Completion (Anticipated): August 1, 2008

Study Registration Dates

• First Submitted: March 16, 2008
• First Submitted That Met QC Criteria: March 20, 2008
• First Posted (Estimate): March 21, 2008

Study Record Updates

• Last Update Posted (Estimate): March 21, 2008
• Last Update Submitted That Met QC Criteria: March 20, 2008
• Last Verified: March 1, 2008

More Information

Terms related to this study

• Keywords: Vitamine D State
• Additional Relevant MeSH Terms: Nutrition Disorders; Avitaminosis; Deficiency Diseases; Malnutrition; Vitamin D Deficiency; Physiological Effects of Drugs; Micronutrients; Vitamins; Bone Density Conservation Agents; Calcifediol
• Other Study ID Numbers: VD-1.CTIL