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

Primary Purpose

Back Pain, Hypovitaminosis D

Status

Completed

Phase

Not Applicable

Locations

Israel

Study Type

Interventional

Intervention

Vitamin D

Placebo

About this trial

This is an interventional treatment trial for Back Pain focused on measuring back pain, hypovitaminosis D

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

patients that are treated with vitamin D

Sites / Locations

Tel Aviv Sourasky Medical Center, Pain Medicine Unit

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

Placebo

Vitamin D

Arm Description

34,500 IU vitamin D per week

Outcomes

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.

Secondary Outcome Measures

Full Information

NCT ID

NCT01023490

First Posted

November 30, 2009

Last Updated

October 14, 2012

Sponsor

Tel-Aviv Sourasky Medical Center

1. Study Identification

Unique Protocol Identification Number

NCT01023490

Brief Title

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

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 Type

Interventional

2. Study Status

Record Verification Date

October 2012

Overall Recruitment Status

Completed

Study Start Date

January 2010 (undefined)

Primary Completion Date

October 2012 (Actual)

Study Completion Date

October 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Tel-Aviv Sourasky Medical Center

4. Oversight

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Back Pain, Hypovitaminosis D

Keywords

back pain, hypovitaminosis D

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

12 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Title

Vitamin D

Arm Type

Active Comparator

Arm Description

34,500 IU vitamin D per week

Intervention Type

Drug

Intervention Name(s)

Vitamin D

Intervention Description

34,5000 IU vitamin D per week

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Placebo

Primary Outcome Measure Information:

Title

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

90 Years

Accepts Healthy Volunteers

Eligibility 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

Facility Information:

Facility Name

Tel Aviv Sourasky Medical Center, Pain Medicine Unit

City

Tel Aviv

Country

Israel

12. IPD Sharing Statement

Learn more about this trial

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

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