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Vitamin D Treatment to Patients Suffering From Chronic Pain and Vitamin D Hypovitaminosis

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ClinicalTrials.gov Identifier: NCT01023490
Recruitment Status : Completed
First Posted : December 2, 2009
Last Update Posted : October 16, 2012
Sponsor:
Information provided by (Responsible Party):
Tel-Aviv Sourasky Medical Center

Brief Summary:
The objective of this study is to check whether vitamin D will lead to a decrease in pain intensity compare to placebo, in patients suffering from chronic pain.

Condition or disease Intervention/treatment Phase
Back Pain Hypovitaminosis D Drug: Vitamin D Drug: Placebo Not Applicable

Detailed Description:

Vitamin D is a complex nutrient that functions as a hormone to benefit numerous body tissues.

Vitamin D is naturally produced by skin exposed to ultraviolet B. Despite the fact that Israel is a sunny country, a majority of all patients, and particularly those with pain, have inadequate intake of vitamin D.

Vitamin D therapy is easy for patients to self administer, well tolerated, and very economical.

In this study, we'll check whether vitamin D will lead to a decrease in pain intensity in patients suffering from chronic low back pain.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Randomised, Double-blind, Placebo-controlled Study to Check Whether Vitamin D Will Lead to a Decrease in Pain Intensity in Patients Suffering From Chronic Pain and Hypovitaminosis D
Study Start Date : January 2010
Actual Primary Completion Date : October 2012
Actual Study Completion Date : October 2012


Arm Intervention/treatment
Placebo Comparator: Placebo Drug: Placebo
Placebo
Active Comparator: Vitamin D
34,500 IU vitamin D per week
Drug: Vitamin D
34,5000 IU vitamin D per week



Primary Outcome Measures :
  1. The objective of this study is to check whether vitamin D will lead to a decrease in pain intensity compare to placebo, in patients suffering from chronic pain. [ Time Frame: one year ]


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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • men and women over 18, who suffer from chronic pain and hypovitaminosis D

Exclusion Criteria:

  • patients that are treated with vitamin D

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): NCT01023490


Locations
Israel
Tel Aviv Sourasky Medical Center, Pain Medicine Unit
Tel Aviv, Israel
Sponsors and Collaborators
Tel-Aviv Sourasky Medical Center

Responsible Party: Tel-Aviv Sourasky Medical Center
ClinicalTrials.gov Identifier: NCT01023490     History of Changes
Other Study ID Numbers: TASMC-09-SB-0494-CTIL
First Posted: December 2, 2009    Key Record Dates
Last Update Posted: October 16, 2012
Last Verified: October 2012

Keywords provided by Tel-Aviv Sourasky Medical Center:
back pain
hypovitaminosis D

Additional relevant MeSH terms:
Rickets
Back Pain
Chronic Pain
Avitaminosis
Vitamin D Deficiency
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Deficiency Diseases
Malnutrition
Nutrition Disorders
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Metabolic Diseases
Calcium Metabolism Disorders
Vitamins
Vitamin D
Ergocalciferols
Micronutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents