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