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

ISRCTN	ISRCTN70909899
DOI	https://doi.org/10.1186/ISRCTN70909899
Clinical Trials Information System (CTIS)	2013-002928-16
Protocol serial number	811700
Sponsor	Individual sponsor (Netherlands)
Funder	Het Achterstandsfonds fund (Netherlands)

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

Primary study design	Interventional
Study design	Randomized controlled trial (double blinded)
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title	Vitamin D and non-specific musculoskeletal complaints in non-Western immigrants: a randomized controlled trial
Study objectives	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(s)	Applied: METCzwh, HAGA Hospital, The Netherlands
Health condition(s) or problem(s) studied	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 / device / biological / vaccine name(s)	Cholecalciferol
Primary outcome measure(s)	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.
Key secondary outcome measure(s)	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.
Completion date	20/03/2015

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Upper age limit	60 Years
Sex	All
Target sample size at registration	240
Key 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
Key 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
Date of first enrolment	20/03/2014
Date of final enrolment	20/03/2015

Locations

Countries of recruitment

Netherlands

Study participating centre

Handellaan 108-D

Delft
2625 SN
Netherlands

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes

Editorial Notes

25/06/2020: No publications found.