Vitamin D suppletion and aspecific musculoskeletal disorders.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON27143

Enrollment

200

Registered

2007-05-12

Start date

2008-02-08

Completion date

Unknown

Last updated

2024-02-28

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

Conditions

Vitamin D suppletion aspecefic musculoskeletal disorders allochtone Vitamine D suppletie Aspecefieke klachten van het bewegingsapparaat Niet-westerse allochtonen

Interventions

150.000 IU vit D3 or placebo in one oral gift at week 0 Idem at week 6 (but: if given placebo at week 0,one will allways get vit D3)

Eligibility

Inclusion criteria

Inclusion criteria: 1. Asian en African men and women, visiting their general practitioners; 2. 18-60yrs; 3. > 13 weeks aspecific musculo-skeletal disorders (i.e. musculoskeletal complaints without a specific cause like: a. trauma or infection or; b. localisation (like gonarthrose) or; complex of symptomes (like HNP, polymyalgia rheumatica). Included are for instance low-backpain, fibromyalgia, fasciitis plantaris. Depression is NOT an exclusioncriterium. 4. Serum 25OHD level < 50nmol/ml.

Exclusion criteria

Exclusion criteria: 1. Pregnancy; 2. Vitamin D suppletion in the last 4 months; 3. Rachitis; 4. Renal insufficiency; 5. Sarcoidosis; 6. TBC; 7. Peanut-allergy; 8. Use of cyclosporines, statines or oral steroids.

Design outcomes

Primary

Measure	Time frame
Differences in improvement of pain as assessed by questionnairies at week 0 and 6 (between placebo- and vit D3-group)	—

Secondary

Measure	Time frame
1. Differences in improvement of pain as assessed by questionnairies at week 12 (between 150.000and 300.000-vit D3-group); 2. Serum 25-OH-D levels at week 12 (150.000 and 300.000 group); 3. Differences in improvement of pain as assessed by questionnairies at week 6 and week 12 (between placebo-vit D3-group and vit D3-placebo-group); 4. Serum 25-OH-D levels at week 12 (placebo-vit D3-group and vit D3-placebo-group); 5. Correlations between localisation of complaints, improvement of pain as assessed by questionnairies, initial serum 25-OH-D levels and serum 25-OH-D levels at week 12. 6. Differences in ability to walk stairs as assessed by questionnairies at week 6 and 12 between placebo and vitamin D group	—

Measure

Time frame

1. Differences in improvement of pain as assessed by questionnairies at week 12 (between 150.000and 300.000-vit D3-group); 2. Serum 25-OH-D levels at week 12 (150.000 and 300.000 group); 3. Differences in improvement of pain as assessed by questionnairies at week 6 and week 12 (between placebo-vit D3-group and vit D3-placebo-group); 4. Serum 25-OH-D levels at week 12 (placebo-vit D3-group and vit D3-placebo-group); 5. Correlations between localisation of complaints, improvement of pain as assessed by questionnairies, initial serum 25-OH-D levels and serum 25-OH-D levels at week 12. 6. Differences in ability to walk stairs as assessed by questionnairies at week 6 and 12 between placebo and vitamin D group

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Contacts

Public ContactF. Schreuder

Handellaan 108

fschreuder01@planet.nl+31-15-2622624

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)