Vitamin D suppletion and aspecific musculoskeletal disorders.

Completed

Conditions: Vitamin D suppletion aspecefic musculoskeletal disorders allochtoneVitamine D suppletie Aspecefieke klachten van het bewegingsapparaatNiet-westerse allochtonen

Registration Number: NL-OMON27143

Brief Summary: Vitamin D Supplementation for Nonspecific Musculoskeletal Pain in Non-Western Immi- grants: A Randomized Controlled Trial.<br> Ferdinand Schreuder, MD1 Roos M. D. Bernsen, PhD2 Johannes C. van der Wouden, PhD1.<br> ANNALS OF FAMILY MEDICINE ✦ WWW.ANNFAMMED.ORG ✦ VOL. 10, NO. 6 ✦ NOVEMBER/DECEMBER 2012.

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 200

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.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Differences in improvement of pain as assessed by questionnairies at week 0<br>and 6 (between placebo- and vit D3-group)<br>

Secondary Outcome Measures

Name	Time	Method
1. Differences in improvement of pain as assessed by questionnairies at week 12<br>(between 150.000and 300.000-vit D3-group);<br>2. Serum 25-OH-D levels at week 12 (150.000 and 300.000 group);<br>3. Differences in improvement of pain as assessed by questionnairies at week 6<br>and week 12 (between placebo-vit D3-group and vit D3-placebo-group);<br>4. Serum 25-OH-D levels at week 12 (placebo-vit D3-group and <br>vit D3-placebo-group);<br>5. Correlations between localisation of complaints, improvement of pain as<br>assessed by questionnairies, initial serum 25-OH-D levels and serum 25-OH-D<br>levels at week 12.<br>6. Differences in ability to walk stairs as assessed by questionnairies at week 6 and 12 between placebo and vitamin D group