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

NCT00640237 | Unknown Phase 3

• 1 other identifier: VD-1.CTIL
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

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.

Conditions

Vitamin D Deficiency

Keywords

Vitamine D State

Outcome Measures

Primary Outcomes (1)

• vitamin D status

  two month

Secondary Outcomes (1)

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

  two month

Study Arms (2)

1

EXPERIMENTAL

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

Dietary Supplement: Alpha-D3

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.

Interventions

Alpha-D3 DIETARY_SUPPLEMENT

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.

Also known as: 25(OH)-D3

1

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Rambam Health Care Campus: lead

Study Sites (1)

Rambam Health Care Campus

Haifa, Israel

RECRUITING

MeSH Terms

Conditions

Vitamin D Deficiency

Interventions

Calcifediol

Condition Hierarchy (Ancestors)

Avitaminosis; Deficiency Diseases; Malnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Hydroxycholecalciferols; Cholecalciferol; Cholestenes; Cholestanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Sterols; Vitamin D; Secosteroids; Membrane Lipids; Lipids

Study Officials

• Ish-Shalom Sofia, Professor

  Rambam Health Care Campus

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ish-Shalom Sofia, Professor

CONTACT

0502061099; s_ish_shalom@rambam.health.gov.il

Nodelmam Marina, MD

CONTACT

mnodelman@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: March 16, 2008
• First Posted: March 21, 2008
• Study Start: March 1, 2008
• Primary Completion: July 1, 2008
• Study Completion: August 1, 2008
• Last Updated: March 21, 2008

Record last verified: 2008-03

Locations

IL (1)