Vitamin D deficiency among non western immigrants: treatment with vitamin D supplementation or sunlight?
| ISRCTN | ISRCTN58849315 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN58849315 |
| Protocol serial number | NTR350; METC 2003-202 |
| Sponsor | VU University Medical Centre (Netherlands) |
| Funder | Netherlands Organisation for Health Research and Development (ZonMw) (Netherlands) |
- Submission date
- 19/12/2005
- Registration date
- 19/12/2005
- Last edited
- 24/08/2009
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nutritional, Metabolic, Endocrine
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Ms Ilse Wicherts
Scientific
Scientific
VU University Medical Center
EMGO - LASA
Van der Boechorststraat 7
Amsterdam
1081 BT
Netherlands
| Phone | +31 (0)20 4449336 |
|---|---|
| i.wicherts@vumc.nl |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Multicentre randomised open label active controlled parallel group trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | |
| Study objectives | Supplementation of vitamin D3 (daily 800 IU or 3 monthly 100,000 IU) has the same effect on muscle complaints and weakness among non western immigrants as daily UV light exposure (sunlight). |
| Ethics approval(s) | Received from local medical ethics committee |
| Health condition(s) or problem(s) studied | Vitamin D deficiency, Muscle weakness |
| Intervention | Time period: 6 months 1. Sunlight exposure: April until 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 |
| Intervention type | Other |
| Primary outcome measure(s) |
1. Muscle strength and mobility (Takei TKK 5001, Hoggan MicroFEt, Chairtest). Measurement: baseline and after 3, 6 and 12 months |
| Key secondary outcome measure(s) |
Sunlight exposure, diet, use of medicine intake, questionnaires: baseline and after 3, 6, 12 months. |
| Completion date | 01/06/2006 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 65 Years |
| Sex | All |
| Target sample size at registration | 210 |
| Key inclusion criteria | 1. 25-OH Vitamin D <25 nmol/l 2. Age during study: 18-65 years 3. Non-western immigrants |
| Key exclusion criteria | 1. No complaints or symptoms 2. No diseases which are interfering with measurement (e.g. psychoses, arthritis of the knee or hip) |
| Date of first enrolment | 15/03/2004 |
| Date of final enrolment | 01/06/2006 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
VU University Medical Center
Amsterdam
1081 BT
Netherlands
1081 BT
Netherlands
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
