Vitamin D Deficiency Clinical Trial
Official title:
The Immune and Clinical Impacts of Vitamin D in Patients With Chronic Musculo-skeletal Pain
Verified date | November 2012 |
Source | Meir Medical Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | Israel: Clalit Health Services |
Study type | Interventional |
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.
Status | Recruiting |
Enrollment | 80 |
Est. completion date | December 2012 |
Est. primary completion date | December 2012 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 80 Years |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Israel | Meir Medical Center | Kfar Saba |
Lead Sponsor | Collaborator |
---|---|
Meir Medical Center |
Israel,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | serologic inflamatory responses with prolong vitamin D therapy | 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 | 6 weeks | No |
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