No registrations found.
ID
Source
Brief title
Sponsors and support
EMGO Institute
Intervention
Outcome measures
Primary outcome
1. Muscle strength and Mobility (Takei TKK 5001, Hoggan MicroFEt, Chairtest). Measurement: baseline and after 3, 6 and 12 months;
2. 25(OH)D, PTH: baseline and after 3,6,12 months;
3. Fosfate, Alkalische fosfatse, Albumin, Creatinine, Glucose Hb, Ht: baseline and after 6 months.
Secondary outcome
Sunlight exposure, diet, use of medicin intake, Questionaries: baseline and after 3,6,12 months.
Background summary
The aim of this study is to determine if the efficacy is the same for supplementation of vitamin D3 (daily 800IU or 3 monthly 100.000IU ) and sunlight exposure on serum 25(OH)D levels, muscle strength and complaints. Non western immigrants with serum 25(OH)D < 25 nmol/l receive treatment during 6 months and are followed for another 6 months. RCT is used as study design.
Study objective
Supplementation of vitamin D3 (daily 800IU or 3 monthly 100.000IU) has the same effect on muscle complaints and weakness among non western immigrants as daily UVlight exposure (sunlight).
Study design
N/A
Intervention
Time period: 6 months.
1. Sunlight exposure: April till Sept;
2. 3 monthly supplementation of vitamin D3 - 100.000 IU, VU University medical center;
3. Daily supplementation of vitamin D3 - 800 IU, , Lommerse Pharma.
Van der Boechorststraat 7
Ilse Wicherts
Van der Boechorststraat 7
Amsterdam 1081 BT
The Netherlands
+31 (0)20 4449336
i.wicherts@vumc.nl
Van der Boechorststraat 7
Ilse Wicherts
Van der Boechorststraat 7
Amsterdam 1081 BT
The Netherlands
+31 (0)20 4449336
i.wicherts@vumc.nl
Inclusion criteria
1. 25(OH)D < 25 nmol/l;
2. Age during study: 18-65 yrs;
3. Non-westerse immigrants.
Exclusion criteria
1. No complaints or symptoms;
2. No diseases which are interfering with measurement (e.g. psychoses, arthritis of the knee or hip).
Design
Recruitment
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 |
|---|---|
| NTR-new | NL312 |
| NTR-old | NTR350 |
| Other | : METC 2003-202 |
| ISRCTN | ISRCTN58849315 |