To investigate the effect of suppletion of vitamin D on aspecific musculo-skeletal disorders
ID
Source
Brief title
Condition
- Muscle disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
difference in complaints between inclusion date and 6 weeks after 150.000 IU
cholecalciferol or 300.000 IU
Secondary outcome
difference in complaints between inclusion date and 12 weeks after 150.000 IU
cholecalciferol (or placebo)
difference in improvement in localisation of complaints
vit D level on inclusion
vit D level at 12 weeks
difference in vit D levels wee12 and on inclusion with 150.000 or 300.000 IU
Background summary
Vitamin D deficiency is common in Asian and African immigrants and their
offspring.
Also are musculo-skeletal disorders.
Several case-reports are published about a healing effect of vitamin D
suppletion as a therapy for this disorders and also some observational studies
suggest this, while others could not find an effect.
No RCT was found in scientific litterature on this subject, though an effect
on muscle strenght seems to be proven and is suggested in the elderly.
Study objective
To investigate the effect of suppletion of vitamin D on aspecific
musculo-skeletal disorders
Study design
Double blinded cross-over RCT
Intervention
1 or 2 times 150.000 IU cholecalciferol
Study burden and risks
Burdon patient: possibility of 6 weeks postponement of treatment for long
lasting complaints
1 extra venapunction
1 extra consult
3 extra registration of complaints (4 questions)
Risk patient: No risk
Handellaan 108
2625 SN Delft
NL
Handellaan 108
2625 SN Delft
NL
Listed location countries
Age
Inclusion criteria
asian or african origin
18-60 yrs
> 6wk complaininig of muscle-pain or weakness
Exclusion criteria
Specific diseases causing musclepain like polymyalgia rheumatica, arthritis (depression or fibromyalgia or somatisationdisorder are no exclusion-criteria)
use of statines or ciclosporine
use of vit D suppletion in the past 4 months
ESR > 30, Kreat > 150 mmol/L
sarcoidose, TBC
Design
Recruitment
Medical products/devices used
metc-ldd@lumc.nl
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2007-001483-79-NL |
| Other | ISRTCN 54027991 |
| CCMO | NL17530.098.07 |