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).
ID
Bron
Verkorte titel
Ondersteuning
EMGO Institute
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
1. Muscle strength and Mobility (Takei TKK 5001, Hoggan MicroFEt, Chairtest). Measurement: baseline and after 3, 6 and 12 months;<br>
2. 25(OH)D, PTH: baseline and after 3,6,12 months;<br>
3. Fosfate, Alkalische fosfatse, Albumin, Creatinine, Glucose Hb, Ht: baseline and after 6 months.
Achtergrond van het onderzoek
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.
Doel van het onderzoek
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).
Onderzoeksopzet
N/A
Onderzoeksproduct en/of interventie
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.
Algemeen / deelnemers
Van der Boechorststraat 7
Ilse Wicherts
Van der Boechorststraat 7
Amsterdam 1081 BT
The Netherlands
+31 (0)20 4449336
i.wicherts@vumc.nl
Wetenschappers
Van der Boechorststraat 7
Ilse Wicherts
Van der Boechorststraat 7
Amsterdam 1081 BT
The Netherlands
+31 (0)20 4449336
i.wicherts@vumc.nl
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
1. 25(OH)D < 25 nmol/l;
2. Age during study: 18-65 yrs;
3. Non-westerse immigrants.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
1. No complaints or symptoms;
2. No diseases which are interfering with measurement (e.g. psychoses, arthritis of the knee or hip).
Opzet
Deelname
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In overige registers
| Register | ID |
|---|---|
| NTR-new | NL312 |
| NTR-old | NTR350 |
| Ander register | : METC 2003-202 |
| ISRCTN | ISRCTN58849315 |