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

NCT01417923 | Unknown Phase 4

• 1 other identifier: 0042-11-MMC
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Vitamin D Deficiency; Chronic Pain Syndrome; Inflammatory Response

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

vitamin D

EXPERIMENTAL

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

Interventions

vitamin D DRUG

P.O.4000 units Vit D per day for 6 weeks

Also known as: VIT D "SOLGAR"

vitamin D

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• We enrolled patients suffering from chronic musculo-skeletal pain (low back pain, fibromyalgia, chronic widespread pain) at least 6 months.

You may not qualify if:

• Patients with low compliance
• Allergy for vit D

Sponsors & Collaborators

• Meir Medical Center: lead

Study Sites (1)

Meir Medical Center

Kfar Saba, 44281, Israel

RECRUITING

MeSH Terms

Conditions

Vitamin D Deficiency

Interventions

Vitamin D

Condition Hierarchy (Ancestors)

Avitaminosis; Deficiency Diseases; Malnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Secosteroids; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Meir Bennun, MD

  Israel:Clalit Health Services, Meir Medical Center, PAIN CLINIC

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 1, 2011
• First Posted: August 16, 2011
• Study Start: September 1, 2011
• Primary Completion: December 1, 2012
• Study Completion: December 1, 2012
• Last Updated: November 6, 2012

Record last verified: 2012-11

Locations

IL (1)