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

Back Pain Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01023490
• Other study ID #: TASMC-09-SB-0494-CTIL
• Status: Completed
• Phase: N/A
• First received: November 30, 2009
• Last updated: October 14, 2012
• Start date: January 2010
• Est. completion date: October 2012

Study information

• Verified date: October 2012
• Source: Tel-Aviv Sourasky Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Ethics Commission
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: October 2012
• Est. primary completion date: October 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• patients that are treated with vitamin D

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Avitaminosis
• Back Pain
• Chronic Pain
• Hypovitaminosis D
• Rickets
• Vitamin D Deficiency

Intervention

Drug:
• Vitamin D
34,5000 IU vitamin D per week
• Placebo
Placebo

Locations

Country	Name	City	State
Israel	Tel Aviv Sourasky Medical Center, Pain Medicine Unit	Tel Aviv

Sponsors (1)

Lead Sponsor	Collaborator
Tel-Aviv Sourasky Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.		one year	No