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

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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN70909899

Enrollment

240

Registered

2013-07-12

Start date

2014-03-20

Completion date

Unknown

Last updated

2020-07-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Locomotor, Depression/bad mood, general practice Musculoskeletal Diseases Vitamin D deficiency, unspecified

Interventions

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 practiti

Eligibility

Sex/Gender

All

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
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.	—

Measure

Time frame

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.

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Secondary

Measure	Time frame
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.	—

Measure

Time frame

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.

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Countries

Netherlands

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026