We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified November 2012 by Meir Medical Center.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01417923
First Posted: August 16, 2011
Last Update Posted: November 6, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Meir Medical Center
  Purpose

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 Intervention Phase
Vitamin D Deficiency Chronic Pain Syndrome Inflammatory Response Drug: vitamin D Phase 4

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Meir Medical Center:

Primary Outcome Measures:
  • 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


Estimated Enrollment: 80
Study Start Date: September 2011
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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"

  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
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
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
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
Principal Investigator: Meir Bennun, MD Israel:Clalit Health Services, Meir Medical Center, PAIN CLINIC
  More Information

Responsible Party: Meir Medical Center
ClinicalTrials.gov Identifier: NCT01417923     History of Changes
Other Study ID Numbers: 0042-11-MMC
First Submitted: August 1, 2011
First Posted: August 16, 2011
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:
Chronic Pain
Vitamin D Deficiency
Musculoskeletal Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Avitaminosis
Deficiency Diseases
Malnutrition
Nutrition Disorders
Muscular Diseases
Musculoskeletal Diseases
Vitamins
Vitamin D
Ergocalciferols
Micronutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents