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
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|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||80 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|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|
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"
- 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
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
|Principal Investigator:||Meir Bennun, MD||Israel:Clalit Health Services, Meir Medical Center, PAIN CLINIC|