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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2012 by Meir Medical Center.
Recruitment status was  Recruiting
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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
Chronic Pain
Musculoskeletal Pain
Vitamin D Deficiency
Avitaminosis
Deficiency Diseases
Malnutrition
Muscular Diseases
Musculoskeletal Diseases
Nervous System Diseases
Neurologic Manifestations
Nutrition Disorders
Pain
Signs and Symptoms
Ergocalciferols
Vitamin D
Vitamins
Bone Density Conservation Agents
Growth Substances
Micronutrients
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on November 23, 2014