| - candidate number | 2580 |
| - NTR Number | NTR970 |
| - ISRCTN | ISRCTN54027991 |
| - Date ISRCTN created | 27-jun-2007 |
| - date ISRCTN requested | 11-jun-2007 |
| - Date Registered NTR | 12-mei-2007 |
| - Secondary IDs | |
| - Public Title | Vitamin D suppletion and aspecific musculoskeletal disorders. |
| - Scientific Title | Vitamin D suppletion and aspecific musculoskeletal disorders. |
| - ACRONYM | |
| - hypothesis | Vitamin D suppletion can relief aspecefic musculoskeletal disorders in allochtone patients. |
| - Healt Condition(s) or Problem(s) studied | Vitamin D suppletion , Aspecific musculoskeletal disorders , Allochtone patients |
| - Inclusion criteria | 1. Asian en African men and women, visiting their general practitioners; 2. 18-60yrs; 3. > 13 weeks aspecific musculo-skeletal disorders (i.e. musculoskeletal complaints without a specific cause like: a. trauma or infection or; b. localisation (like gonarthrose) or; complex of symptomes (like HNP, polymyalgia rheumatica). Included are for instance low-backpain, fibromyalgia, fasciitis plantaris. Depression is NOT an exclusioncriterium. 4. Serum 25OHD level < 50nmol/ml. |
| - Exclusion criteria | 1. Pregnancy; 2. Vitamin D suppletion in the last 4 months; 3. Rachitis; 4. Renal insufficiency; 5. Sarcoidosis; 6. TBC; 7. Peanut-allergy; 8. Use of cyclosporines, statines or oral steroids. |
| - mec approval received | yes |
| - multicenter trial | yes |
| - randomised | yes |
| - masking/blinding | Double |
| - control | Placebo |
| - group | Crossover |
| - Type | [default] |
| - Studytype | intervention |
| - planned startdate | 8-feb-2008 |
| - planned closingdate | 1-feb-2009 |
| - Target number of participants | 200 |
| - Interventions | 150.000 IU vit D3 or placebo in one oral gift at week 0 Idem at week 6 (but: if given placebo at week 0,one will allways get vit D3) |
| - Primary outcome | Differences in improvement of pain as assessed by questionnairies at week 0 and 6 (between placebo- and vit D3-group) |
| - Secondary outcome | 1. Differences in improvement of pain as assessed by questionnairies at week 12 (between 150.000and 300.000-vit D3-group); 2. Serum 25-OH-D levels at week 12 (150.000 and 300.000 group); 3. Differences in improvement of pain as assessed by questionnairies at week 6 and week 12 (between placebo-vit D3-group and vit D3-placebo-group); 4. Serum 25-OH-D levels at week 12 (placebo-vit D3-group and vit D3-placebo-group); 5. Correlations between localisation of complaints, improvement of pain as assessed by questionnairies, initial serum 25-OH-D levels and serum 25-OH-D levels at week 12. 6. Differences in ability to walk stairs as assessed by questionnairies at week 6 and 12 between placebo and vitamin D group |
| - Timepoints | |
| - Trial web site | |
| - status | stopped: trial finished |
| - CONTACT FOR PUBLIC QUERIES | F. Schreuder |
| - CONTACT for SCIENTIFIC QUERIES | F. Schreuder |
| - Sponsor/Initiator | F. Schreuder |
| - Funding (Source(s) of Monetary or Material Support) | F. Schreuder |
| - Publications | Vitamin D Supplementation for Nonspecific Musculoskeletal Pain in Non-Western Immi- grants: A Randomized Controlled Trial. Ferdinand Schreuder, MD1 Roos M. D. Bernsen, PhD2 Johannes C. van der Wouden, PhD1. ANNALS OF FAMILY MEDICINE ✦ WWW.ANNFAMMED.ORG ✦ VOL. 10, NO. 6 ✦ NOVEMBER/DECEMBER 2012. |
| - Brief summary | In several primary health centers placebo or (1-2x) 150.000 IU will be given to Vit D deficient patients with aspecific musculoskeletal disorders. Questionairies i will show wheter this helps them or not |
| - Main changes (audit trail) | |
| - RECORD | 12-mei-2007 - 14-nov-2012 |
- Indien u gegevens wilt toevoegen of veranderen, kunt u een mail sturen naar nederlands@trialregister.nl