| - candidate number | 2205 |
| - NTR Number | NTR796 |
| - ISRCTN | ISRCTN12365646 |
| - Date ISRCTN created | 28-dec-2006 |
| - date ISRCTN requested | 18-dec-2006 |
| - Date Registered NTR | 10-aug-2006 |
| - Secondary IDs | 2006/160 MEC VU |
| - Public Title | The effects of low dose 1,25-dihydroxyvitamin D3 on the polarising of cellular immune reactivity towards type 2 immunity. |
| - Scientific Title | The effects of 1,25-dihydroxyvitamin D3 on immune reactivity towards type 2 immunity. |
| - ACRONYM | N/A |
| - hypothesis | 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. |
| - Healt Condition(s) or Problem(s) studied | Auto-immune diseases |
| - Inclusion criteria | 1. Written informed consent; 2. women, aged 20-30 years; 3. use of oral contraception with estrogen and progestin; 4. apparently health. |
| - Exclusion criteria | 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. |
| - mec approval received | yes |
| - multicenter trial | no |
| - randomised | yes |
| - masking/blinding | Double |
| - control | Placebo |
| - group | Parallel |
| - Type | 2 or more arms, randomized |
| - Studytype | intervention |
| - planned startdate | 15-nov-2006 |
| - planned closingdate | 15-mrt-2007 |
| - Target number of participants | 24 |
| - Interventions | 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. |
| - Primary outcome | 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. |
| - Secondary outcome | We expect the type 1 cytokines to be decreased and the type 2 cytokines to be upregulated. |
| - Timepoints | N/A |
| - Trial web site | N/A |
| - status | inclusion stopped: follow-up |
| - CONTACT FOR PUBLIC QUERIES | mw. C.M. Dinkgreve |
| - CONTACT for SCIENTIFIC QUERIES | dr. E.M.W. Eekhoff |
| - Sponsor/Initiator | VU University Medical Center, Department of Endocrinology |
| - Funding (Source(s) of Monetary or Material Support) | Medicina Interna |
| - Publications | N/A |
| - Brief summary | N/A |
| - Main changes (audit trail) | |
| - RECORD | 10-aug-2006 - 16-nov-2009 |
- Indien u gegevens wilt toevoegen of veranderen, kunt u een mail sturen naar nederlands@trialregister.nl