Condition category
Musculoskeletal Diseases
Date applied
26/06/2013
Date assigned
12/07/2013
Last edited
21/03/2014
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

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

Trial website

Contact information

Type

Scientific

Primary contact

Dr Ferdinand Schreuder

ORCID ID

Contact details

Handellaan 108-D
Delft
2625 SN
Netherlands
0031-15-2622624
fschreuder01@planet.nl

Additional identifiers

EudraCT number

2013-002928-16

ClinicalTrials.gov number

Protocol/serial number

811700

Study information

Scientific title

Vitamin D and non-specific musculoskeletal complaints in non-Western immigrants: a randomized controlled trial

Acronym

Study hypothesis

Vitamin 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

Applied: METCzwh, HAGA Hospital, The Netherlands

Study design

Randomized controlled trial (double blinded)

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

GP practices

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Locomotor, Depression/bad mood, general practice

Intervention

Current 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 type

Drug

Phase

Not Specified

Drug names

Cholecalciferol

Primary outcome measures

Current 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 measures

Secondary 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 trial start date

20/03/2014

Overall trial end date

20/03/2015

Reason abandoned

Eligibility

Participant inclusion criteria

1. 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

240

Participant exclusion criteria

1. 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

Recruitment start date

20/03/2014

Recruitment end date

20/03/2015

Locations

Countries of recruitment

Netherlands

Trial participating centre

Handellaan 108-D
Delft
2625 SN
Netherlands

Sponsor information

Organisation

Individual sponsor (Netherlands)

Sponsor details

F. Schreuder
Handellaan 108-D
2625 SN Delft
Delft
2625SN
Netherlands
0031-15-2622624
fschreuder01@planet.nl

Sponsor type

Other

Website

Funders

Funder type

Industry

Funder name

Het Achterstandsfonds fund (Netherlands)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes