Short term oral low dose 1,25(OH)2D3 in man will increase type-2 and decrease type-1 cellular immune reactivity without affecting serum calcium levels. Hereby, the potential usage of 1,25(OH)2D3 for immuno-therapeutical approaches will be…
ID
Bron
Verkorte titel
Aandoening
auto-immune diseases
Ondersteuning
endocrinology
Vu university medical centre
De Boelelaan 1118
1081 HV
Netherlands
Tel:+31-20-4440533
Fax:+31-20-4440502
emw.eekhoff@vumc.nl
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
We expect the serum level of 1,25(OH)2D3 to rise and to induce the activity of T lymphocytes and the dendritic cells which regulate the immunity and reduce the activity of type 1 T lymphocytes involved in auto-immune diseases. Their activity will be measured by the decrease of interferon gamma production.
Achtergrond van het onderzoek
N/A
Doel van het onderzoek
Short term oral low dose 1,25(OH)2D3 in man will increase type-2 and decrease type-1 cellular immune reactivity without affecting serum calcium levels. Hereby, the potential usage of 1,25(OH)2D3 for immuno-therapeutical approaches will be investigated.
Onderzoeksopzet
N/A
Onderzoeksproduct en/of interventie
Twelve volunteers will receive 10 capsules of 0,5 µg calcitriol, the other twelve volunteers will receive 10 capsules placebo. They have to take the medication twice a day during 5 days.
Publiek
De Boelelaan 1118
C.M. Dinkgreve
Amsterdam 1081 HV
The Netherlands
+31(0)20 4440533
cm.dinkgreve@vumc.nl
Wetenschappelijk
De Boelelaan 1118
C.M. Dinkgreve
Amsterdam 1081 HV
The Netherlands
+31(0)20 4440533
cm.dinkgreve@vumc.nl
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
1. Written informed consent;
2. women, aged 20-30 years;
3. use of oral contraception with estrogen and progestin;
4. apparently health.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
1. Men;
2. pregnancy;
3. smoking;
4. alcohol abuse: > 3 Units/day;
5. use of drugs, except for incidental analgesic agents;
6. use of diuretic medication or corticosteroids;
7. auto immune diseases;
8. renal impairment (serum creatinine >150
µmol/l);
9. malignant disease;
10. kidney-stones (also when this occurs in the family), urinary tract infections;
11. infectious diseases;
12. use of antibiotics;
13. use of any medication that influence T-
lymphocytes or vitamin D metabolism;
14. disease or use of any medication known to affect Ca metabolism or skeletal physiology;
15. serious mental impairment i.e. preventing to understand the study protocol/aim.
Opzet
Deelname
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Andere (mogelijk minder actuele) registraties in dit register
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In overige registers
| Register | ID |
|---|---|
| NTR-new | NL784 |
| NTR-old | NTR796 |
| Ander register | MEC VU : 2006/160 |
| ISRCTN | ISRCTN12365646 |