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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Tel-Aviv Sourasky Medical Center
ClinicalTrials.gov Identifier:
NCT01023490
First received: November 30, 2009
Last updated: October 14, 2012
Last verified: October 2012
  Purpose

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 Intervention
Back Pain
Hypovitaminosis D
Drug: Vitamin D
Drug: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:


Further study details as provided by Tel-Aviv Sourasky Medical Center:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 12
Study Start Date: January 2010
Study Completion Date: October 2012
Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01023490

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

No publications provided

Responsible Party: Tel-Aviv Sourasky Medical Center
ClinicalTrials.gov Identifier: NCT01023490     History of Changes
Other Study ID Numbers: TASMC-09-SB-0494-CTIL
Study First Received: November 30, 2009
Last Updated: October 14, 2012
Health Authority: Israel: Ethics Commission

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

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

ClinicalTrials.gov processed this record on April 16, 2014