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Vitamin D deficiency among non western immigrants: treatment with vitamin D supplementation or sunlight?


- candidate number1711
- NTR NumberNTR350
- ISRCTNISRCTN58849315
- Date ISRCTN created19-dec-2005
- date ISRCTN requested28-okt-2005
- Date Registered NTR20-sep-2005
- Secondary IDsMETC 2003-202 
- Public TitleVitamin D deficiency among non western immigrants: treatment with vitamin D supplementation or sunlight?
- Scientific TitleVitamin D deficiency among non western immigrants: treatment with vitamin D supplementation or sunlight?
- ACRONYMN/A
- hypothesisSupplementation 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).
- Healt Condition(s) or Problem(s) studiedVitamin D deficiency, Muscle weakness
- Inclusion criteria1. 25(OH)D < 25 nmol/l;
2. Age during study: 18-65 yrs;
3. Non-westerse immigrants.
- Exclusion criteria1. No complaints or symptoms;
2. No diseases which are interfering with measurement (e.g. psychoses, arthritis of the knee or hip).
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingNone
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 15-mrt-2004
- planned closingdate1-jun-2006
- Target number of participants210
- InterventionsTime 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.
- Primary outcome1. 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 outcomeSunlight exposure, diet, use of medicin intake, Questionaries: baseline and after 3,6,12 months.
- TimepointsN/A
- Trial web siteN/A
- statusinclusion stopped: follow-up
- CONTACT FOR PUBLIC QUERIES Ilse Wicherts
- CONTACT for SCIENTIFIC QUERIESProf. P. Lips
- Sponsor/Initiator VU University Medical Center, EMGO+ Institute
- Funding
(Source(s) of Monetary or Material Support)
ZON-MW, The Netherlands Organization for Health Research and Development
- PublicationsN/A
- Brief summaryThe 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.
- Main changes (audit trail)
- RECORD20-sep-2005 - 18-nov-2008


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