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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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Netherlands Trial Register |
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Last refreshed on:
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28 April 2013 |
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Main ID: |
NTR970 |
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Date of registration:
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12/05/2007 |
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Primary sponsor: |
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Public title:
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Vitamin D suppletion and aspecific musculoskeletal disorders.
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Scientific title:
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Vitamin D suppletion and aspecific musculoskeletal disorders. -
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Date of first enrolment:
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8/2/2008 |
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Target sample size:
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200 |
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Recruitment status: |
complete |
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URL:
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http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=970 |
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Study type:
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intervention |
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Study design:
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Randomised: Yes; Masking: Double; Control: Placebo; Group: Crossover; Type: [default]
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Countries of recruitment
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The Netherlands
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Contacts
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Name:
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F.
Schreuder |
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Address:
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Handellaan 108
2625 SN
Delft
The Netherlands |
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Telephone:
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+31-15-2622624 |
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Email:
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fschreuder01@planet.nl |
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Affiliation:
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Name:
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F.
Schreuder |
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Address:
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Handellaan 108
2625 SN
Delft
The Netherlands |
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Telephone:
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+31-15-2622624 |
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Email:
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fschreuder01@planet.nl |
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Affiliation:
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Key inclusion & exclusion criteria
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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: 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.
Age minimum:
Age maximum:
Gender:
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Health Condition(s) or Problem(s) studied
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Vitamin D suppletion , Aspecific musculoskeletal disorders , Allochtone patients
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Intervention(s)
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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)
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Primary Outcome(s)
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Differences in improvement of pain as assessed by questionnairies at week 0
and 6 (between placebo- and vit D3-group)
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Secondary Outcome(s)
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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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Secondary ID(s)
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ISRCTN54027991
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Source(s) of Monetary Support
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F. Schreuder
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