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

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ClinicalTrials.gov Identifier: NCT01417923
Recruitment Status : Unknown
Verified November 2012 by Meir Medical Center.
Recruitment status was:  Recruiting
First Posted : August 16, 2011
Last Update Posted : November 6, 2012
Sponsor:
Information provided by (Responsible Party):
Meir Medical Center

Study Description
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Brief Summary:

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 or disease Intervention/treatment Phase
Vitamin D Deficiency Chronic Pain Syndrome Inflammatory Response Drug: vitamin D Phase 4

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Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: The Immune and Clinical Impacts of Vitamin D in Patients With Chronic Musculo-skeletal Pain
Study Start Date : September 2011
Estimated Primary Completion Date : December 2012
Estimated Study Completion Date : December 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vitamin D
Drug Information available for: Vitamin D

Arms and Interventions
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Arm Intervention/treatment
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"


Outcome Measures
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Primary Outcome Measures :
  1. serologic inflamatory responses with prolong vitamin D therapy [ Time Frame: 6 weeks ]
    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


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01417923


Locations
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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
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Principal Investigator: Meir Bennun, MD Israel:Clalit Health Services, Meir Medical Center, PAIN CLINIC
More Information
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Responsible Party: Meir Medical Center
ClinicalTrials.gov Identifier: NCT01417923     History of Changes
Other Study ID Numbers: 0042-11-MMC
First Posted: August 16, 2011    Key Record Dates
Last Update Posted: November 6, 2012
Last Verified: November 2012
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:
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Musculoskeletal Pain
Vitamin D Deficiency
Chronic Pain
Pain
Neurologic Manifestations
Signs and Symptoms
Avitaminosis
Deficiency Diseases
Malnutrition
Nutrition Disorders
Muscular Diseases
 Musculoskeletal Diseases
Vitamin D
Ergocalciferols
Vitamins
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents
Calcium-Regulating Hormones and Agents