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