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The effects of low dose 1,25-dihydroxyvitamin D3 on the polarising of cellular immune reactivity towards type 2 immunity.


- candidate number2205
- NTR NumberNTR796
- ISRCTNISRCTN12365646
- Date ISRCTN created28-dec-2006
- date ISRCTN requested18-dec-2006
- Date Registered NTR10-aug-2006
- Secondary IDs2006/160 MEC VU
- Public TitleThe effects of low dose 1,25-dihydroxyvitamin D3 on the polarising of cellular immune reactivity towards type 2 immunity.
- Scientific TitleThe effects of 1,25-dihydroxyvitamin D3 on immune reactivity towards type 2 immunity.
- ACRONYMN/A
- hypothesisShort 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.
- Healt Condition(s) or Problem(s) studiedAuto-immune diseases
- Inclusion criteria1. Written informed consent;
2. women, aged 20-30 years;
3. use of oral contraception with estrogen and progestin;
4. apparently health.
- Exclusion criteria1. 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.
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingDouble
- controlPlacebo
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 15-nov-2006
- planned closingdate15-mrt-2007
- Target number of participants24
- InterventionsTwelve 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.
- Primary outcomeWe 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.
- Secondary outcomeWe expect the type 1 cytokines to be decreased and the type 2 cytokines to be upregulated.
- TimepointsN/A
- Trial web siteN/A
- statusinclusion stopped: follow-up
- CONTACT FOR PUBLIC QUERIESmw. C.M. Dinkgreve
- CONTACT for SCIENTIFIC QUERIESdr. E.M.W. Eekhoff
- Sponsor/Initiator VU University Medical Center, Department of Endocrinology
- Funding
(Source(s) of Monetary or Material Support)
Medicina Interna
- PublicationsN/A
- Brief summaryN/A
- Main changes (audit trail)
- RECORD10-aug-2006 - 16-nov-2009


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