Vitamin D and non-specific musculoskeletal complaints in non-Western immigrants
Withdrawn
- Conditions
- muscle painnon-specific musculoskeletal complaints1002839310027946
- Registration Number
- NL-OMON40574
- Lead Sponsor
- Huisartsenpraktijk Handellaan
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Withdrawn
- Sex
- Not specified
- Target Recruitment
- 200
Inclusion Criteria
non-Western immigrants, 18-60 yr, not pregnant
non-specific musculoskeletal complaints (<= all musculoskeletal complaints without obvious cause (e.g. trauma, R.A.) or well-defined symptomatology or localisation (e.g. gonarthrosis, HNP) diagnosis like low back pain, cervico-brachial syndrome or fasciitis plantaris etc. are included. Depression is NOT an exclusion-criterium)
a. lasting > 12 wks
or b. 3 period (or more) of pain >1 month in 2 yr
25-OH-D < 50nmol/L
Exclusion Criteria
Pregnancy
Supplementation with vitamin D in the last 4 months
Rachitis, Osteomalacia, Sarcoidose, ESR>35, kreatinine > 150 mmol/L, Calcium > 2,55 mmol/L
Use of Statines, Corticosteroids or Cyclosporin
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Our primary goal is to assess the difference in self-reported improvement of<br /><br>pain 12 weeks after administration of placebo or 2x 200.000 IU cholecalciferol<br /><br>. </p><br>
- Secondary Outcome Measures
Name Time Method <p>Secondary outcome measures will be: self-reported improvement of pain in 6<br /><br>weeks, (improvement of) mood and fatigue at week six 6 and week 12 and<br /><br>correlation of these improvements with eachother and with the level of 25-OH-D<br /><br>and with bio-available vitamin D at start. Also we will assess improvement in<br /><br>ability to walk stairs at week six and week 12 and correlation with pain in the<br /><br>legs and fatigue at baseline<br /><br>Correlation of VAS-scores for pain with self-reported pain will be assessed<br /><br>too.</p><br>