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 |
Status | Clinical Trial | Phase | |
---|---|---|---|
Active, not recruiting |
NCT04244474 -
Effect of Vitamin D Supplementation on Improvement of Pneumonic Children
|
Phase 1/Phase 2 | |
Recruiting |
NCT05459298 -
ViDES Trial (Vitamin D Extra Supplementation)
|
N/A | |
Completed |
NCT04476511 -
The Efficacy and the Safety of Vitamin D3 30,000 IU for Loading Dose Schedules
|
Phase 3 | |
Suspended |
NCT03652987 -
Endocrine and Menstrual Disturbances in Women With Polycystic Ovary Syndrome (PCOS)
|
||
Completed |
NCT03920150 -
Vitamin D 24'000 IU for Oral Intermittent Supplementation
|
Phase 3 | |
Completed |
NCT03264625 -
The Effects of Oral Vitamin D Supplementation on the Prevention of Peritoneal Dialysis-related Peritonitis
|
Phase 2 | |
Completed |
NCT04183257 -
Effect of Escalating Oral Vitamin D Replacement on HOMA-IR in Vitamin D Deficient Type 2 Diabetics
|
Phase 4 | |
Recruiting |
NCT05084248 -
Vitamin D Deficiency in Adults Following a Major Burn Injury
|
Phase 4 | |
Completed |
NCT05506696 -
Vitamin D Supplementation Study
|
N/A | |
Completed |
NCT00092066 -
A Study to Evaluate the Safety, Tolerability, and Efficacy of an Investigational Drug and Dietary Supplement in Men and Postmenopausal Women With Osteoporosis (0217A-227)
|
Phase 3 | |
Completed |
NCT03234218 -
Vitamin D Levels in Liver Transplantation Recipients Prospective Observational Study
|
||
Completed |
NCT03203382 -
Corneal Nerve Structure in Sjogren's
|
||
Completed |
NCT02906319 -
Vitamin D and HbA1c Levels in Diabetic Patients With CKD
|
N/A | |
Completed |
NCT02714361 -
A Study to Investigate the Effect of Vitamin D3 Supplementation on Iron Status in Iron Deficient Women
|
N/A | |
Completed |
NCT02118129 -
Vitamin D Among Young Adults: an Intervention Study Using a Mobile 'App'.
|
N/A | |
Completed |
NCT02275650 -
The Role of Narrowband Ultraviolet B Exposure in the Maintenance of Vitamin D Levels During Winter
|
N/A | |
Not yet recruiting |
NCT01419821 -
Vitamin D and Its Affect on Growth Rates and Bone Mineral Density Until Age 5
|
N/A | |
Completed |
NCT02187146 -
The Effects of Serum Vitamin D and IVF Outcome
|
N/A | |
Completed |
NCT01688102 -
The Effect of Oral Vitamin D Versus Narrow-Band UV-B Exposure on the Lipid Profile
|
N/A | |
Completed |
NCT01741181 -
Vitamin D Supplementation in Patients With Diabetes Mellitus Type 2
|
Phase 4 |