Vitamin D and non-specific musculoskeletal complaints in non-Western immigrants

ISRCTN ISRCTN70909899
DOI https://doi.org/10.1186/ISRCTN70909899
EudraCT/CTIS number 2013-002928-16
Secondary identifying numbers 811700
Submission date
26/06/2013
Registration date
12/07/2013
Last edited
25/06/2020
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Musculoskeletal Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English summary of protocol

Background and study aims
Muscle pains without a known cause can last for months or years and are frequently seen in general practice. Also, vitamin D deficiency is a rather common condition, as is bad mood or depression. All these three conditions are more common in non-Western immigrants than they are in Caucasian people. Though a clear relation is known between bad mood or depression and muscle pain and though research found s relation between vitamin D deficiency and this complaint, it is still not sure that vitamin D supplementation can help to relieve these pains. Even more approximate is its effect on mood. This study aims to bring light on these issues and to help doctors and patients to make their decisions on vitamin D-supplementation.

Who can participate?
Non-Western immigrants, aged 16-60 years, with lasting muscle pain without any known cause and with low vitamin D levels in blood, can participate in this study.

What does the study involve?
Patients will be randomly allocated to either receive 2x150.000 IU vitamin D3 or placebo in 12 weeks, whilst they themselves nor their doctor knows which one. After these 12 weeks everybody gets a third dose, in the way that every patient has got at least one time vitamin D.

What are the possible benefits and risks of participating?
This treatment is surely harmless and the main drawback for participating is, that half of the patients get their vitamin D several weeks later. This study can help doctors to recognize depression in the participants. This is sometimes overlooked in general practice when language problems and cultural differences slow down good communication.

Where is the study run from?
The study is run from 25 general practices in Netherlands.

When is study starting and how long is it expected to run for?
The study is planned to start by March 2014 and is expected to last for two years.

Who is funding the study?
This study is funded by Merck (Netherlands) (Application in progress) and Het Achterstandsfonds fund (Netherlands).

Who is the main contact?
Dr Ferdinand Schreuder
Fschreuder01@planet.nl

Contact information

Dr Ferdinand Schreuder
Scientific

Handellaan 108-D
Delft
2625 SN
Netherlands

Phone 0031-15-2622624
Email fschreuder01@planet.nl

Study information

Study designRandomized controlled trial (double blinded)
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)GP practice
Study typeTreatment
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet
Scientific titleVitamin D and non-specific musculoskeletal complaints in non-Western immigrants: a randomized controlled trial
Study objectivesVitamin D supplementation can relieve non-specific musculoskeletal pain.

On 21/03/2014 the following changes were made to the trial record:
1. The anticipated start date was changed from 01/12/2013 to 20/03/2014
2. The anticipated end date was changed from 01/12/2015 to 20/03/2015
3. The target number of participants was changed from 230 to 240
Ethics approval(s)Applied: METCzwh, HAGA Hospital, The Netherlands
Health condition(s) or problem(s) studiedLocomotor, Depression/bad mood, general practice
InterventionCurrent interventions as of 21/03/2014:
Placebo and 200,000 IU Vitamin D (Verum) will be administered as a 10 ml bottle to drink under supervision at the office of the general practitioner, right after answering the questionnaires. Bottles nor fluid can be distinguished by aspect or taste.
Patients are randomized to two groups:
Treatment arm: Receives Verum on day 0 (baseline) and day 42
Placebo arm: Receives placebo on day 0 and day 42
Likert scales concern improvement, so will not be assessed at baseline.

Previous interventions:
Placebo and 150,000 IU Vitamin D (Verum) will be administered as a 7.5 ml bottle to drink under supervision at the office of the general practitioner, right after answering the questionnaires. Bottles nor fluid can be distinguished by aspect or taste.
Patients are randomized to two groups:
Treatment arm: Receives Verum on day 0 (baseline), day 42 and placebo on day 84
Placebo arm: Receives placebo on day 0, day 42 and Verum on day 84
Likert scales concern improvement, so will not be assessed at baseline.
Intervention typeDrug
Pharmaceutical study type(s)
PhaseNot Specified
Drug / device / biological / vaccine name(s)Cholecalciferol
Primary outcome measureCurrent primary outcome measures as of 21/03/2014:
Our primary goal is to assess the difference in self-reported improvement of pain (5-point Likert scale) 12 weeks after administration of placebo or 2 x 200.000 IU cholecalciferol. Measured on day 42, and day 84.

Previous primary outcome measures:
Our primary goal is to assess the difference in self-reported improvement of pain (5-point Likert scale) 12 weeks after administration of placebo or 2 x 150.000 IU cholecalciferol. Measured on day 42, day 84 and day 96.
Secondary outcome measuresSecondary outcome measures will be:
1. Self-reported improvement of pain in 6 weeks
2. Improvement of mood at week six and week 12 and correlation of these improvements with level of 25-OH-D at start
3. Correlation of improvement of mood with self-reported improvement of pain
4. Improvement in ability to walk up the stairs at week six and week 12
5. Correlation of VAS-scores for pain with self-reported pain (all 5 point Likert scales)
Added 21/03/2014: 6. Correlation of self-reported improvement of pain in 12 weeks and 'bioavailable vitamin D' at baseline

All outcomes are measured on day 0, 42, 84 and 96.
Overall study start date20/03/2014
Completion date20/03/2015

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
Upper age limit60 Years
SexBoth
Target number of participants240
Key inclusion criteria1. Non-Western immigrants
2. Aged 18-60 years
3. 25-hydroxyvitamin D (25-OH-D) level less than 50 nmol/L
4. Non-specific musculoskeletal complaints
4.1. lasting for more than12 weeks
4.2. 3 periods in the last two years, each more than 1 month
Note: depression is NOT an exclusion criterion
Key exclusion criteria1. Vitamin D supplementation in the last 4 months
2. Rachitis
3. Low kidney function (creatinine > 150 nmol/L), Sarcoidosis, hypercalcaemia
4. ESR > 35, use of corticosteroids, cyclosporin, statins
Date of first enrolment20/03/2014
Date of final enrolment20/03/2015

Locations

Countries of recruitment

  • Netherlands

Study participating centre

Handellaan 108-D
Delft
2625 SN
Netherlands

Sponsor information

Individual sponsor (Netherlands)
Other

F. Schreuder
Handellaan 108-D
2625 SN Delft
Delft
2625SN
Netherlands

Phone 0031-15-2622624
Email fschreuder01@planet.nl

Funders

Funder type

Industry

Het Achterstandsfonds fund (Netherlands)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Editorial Notes

25/06/2020: No publications found.