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Vitamin D suppletion and aspecific musculoskeletal disorders.


- candidate number2580
- NTR NumberNTR970
- ISRCTNISRCTN54027991
- Date ISRCTN created27-jun-2007
- date ISRCTN requested11-jun-2007
- Date Registered NTR12-mei-2007
- Secondary IDs 
- Public TitleVitamin D suppletion and aspecific musculoskeletal disorders.
- Scientific TitleVitamin D suppletion and aspecific musculoskeletal disorders.
- ACRONYM
- hypothesisVitamin D suppletion can relief aspecefic musculoskeletal disorders in allochtone patients.
- Healt Condition(s) or Problem(s) studiedVitamin D suppletion , Aspecific musculoskeletal disorders , Allochtone patients
- Inclusion criteria1. 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 criteria1. 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 receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingDouble
- controlPlacebo
- groupCrossover
- Type[default]
- Studytypeintervention
- planned startdate 8-feb-2008
- planned closingdate1-feb-2009
- Target number of participants200
- Interventions150.000 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 outcomeDifferences in improvement of pain as assessed by questionnairies at week 0 and 6 (between placebo- and vit D3-group)
- Secondary outcome1. 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
- statusstopped: 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
- PublicationsVitamin 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 summaryIn 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)
- RECORD12-mei-2007 - 14-nov-2012


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