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The Immune and Clinical Impacts of Vitamin D in Patients With Chronic Musculo-skeletal Pain

This study is currently recruiting participants.
Verified November 2012 by Meir Medical Center
Sponsor:
Information provided by (Responsible Party):
Meir Medical Center
ClinicalTrials.gov Identifier:
NCT01417923
First received: August 1, 2011
Last updated: November 4, 2012
Last verified: November 2012
History of Changes
  Purpose

Vitamin D3 is produced in the skin following exposure to UVB light from the sun or artificial sources, and occurs naturally in a small range of foods.More recently, several reports underlined the impact of vitamin D on the prevalence and consequences of inadequate vitamin D intake and the research supporting its benefits for alleviating chronic musculoskeletal pain and fatigue syndromes in outpatients. Experts have recommended that vitamin D inadequacy should be addressed in all patients with bone or joint pain, myalgia, fibromyalgia, or chronic fatigue syndrome. It appears that soothing the daily musculoskeletal pain by supplementation of vitamin D may be a simple, well tolerated, and cost-effective modality.

Aim of study:

To study the potential therapeutic effects of vitamin D supplementation on patients with persistent musculo-skeletal pain. Clinicalparameters, visual analog score,short form McGill Pain Questionnaire,patient global perceived effect, quality of life assessed by SF-36 Questionnaire and laboratory parameters, the levels of 25 OH-Vitamin D, CRP, IL-6, IL-8, TNF and prostaglandin E will be assessed.


Condition Intervention Phase
Vitamin D Deficiency
Chronic Pain Syndrome
Inflammatory Response
 Drug: vitamin D
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: The Immune and Clinical Impacts of Vitamin D in Patients With Chronic Musculo-skeletal Pain

Resource links provided by NLM:

Drug Information available for: Vitamin D
U.S. FDA Resources

Further study details as provided by Meir Medical Center:

Primary Outcome Measures:
  • serologic inflamatory responses with prolong vitamin D therapy [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    On the day of recruitment blood will be drawn in order to determine the levels of 25 OH-Vitamin D, CRP, IL-6, IL-8, TNF and prostaglandin E2. Vitamin D or placebo will be taken for 6 weeks on top of the individual's daily medications. A second blood analysis will be conducted following the 6 week duration


Estimated Enrollment: 80
Study Start Date: September 2011
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: vitamin D
We enrolled 80 patients of the age 18-80 years suffering from chronic musculo-skeletal pain (low back pain, fibromyalgia, chronic widespread pain) at least 6 months. The 40 patients will receive daily doses of 4000 units of vitamin D for 6 weeks
 Drug: vitamin D
P.O.4000 units Vit D per day for 6 weeks
Other Name: VIT D "SOLGAR"

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • We enrolled patients suffering from chronic musculo-skeletal pain (low back pain, fibromyalgia, chronic widespread pain) at least 6 months.

Exclusion Criteria:

  • Patients with low compliance
  • Allergy for vit D
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01417923

Locations
Israel
Meir Medical Center Recruiting
Kfar Saba, Israel, 44281
Contact: Meir Ben-nun, MD     97297472651     meir.ben-nun@clalit.org.il    
Contact: Sergey Makarov, MD     97297471545     sergey.makarov@clalit.org.il    
Sponsors and Collaborators
Meir Medical Center
Investigators
Principal Investigator: Meir Bennun, MD Israel:Clalit Health Services, Meir Medical Center, PAIN CLINIC
  More Information

No publications provided

Responsible Party: Meir Medical Center
ClinicalTrials.gov Identifier: NCT01417923     History of Changes
Other Study ID Numbers: 0042-11-MMC
Study First Received: August 1, 2011
Last Updated: November 4, 2012
Health Authority: Israel: Clalit Health Services

Keywords provided by Meir Medical Center:
chronic musculo-skeletal pain
therapeutic&serology effects of vitamin D
CRP, IL-6, IL-8, TNF and prostaglandin E2
patients suffering from chronic musculo-skeletal pain

Additional relevant MeSH terms:
Vitamin D Deficiency
Avitaminosis
Deficiency Diseases
Malnutrition
Nutrition Disorders
Vitamin D
Ergocalciferols
 Vitamins
Bone Density Conservation Agents
Physiological Effects of Drugs
Pharmacologic Actions
Micronutrients
Growth Substances

ClinicalTrials.gov processed this record on June 13, 2013