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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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Netherlands Trial Register |
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Last refreshed on:
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28 April 2013 |
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Main ID: |
NTR796 |
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Date of registration:
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10/08/2006 |
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Primary sponsor: |
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Public title:
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The effects of low dose 1,25-dihydroxyvitamin D3 on the polarising of cellular immune reactivity towards type 2 immunity.
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Scientific title:
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The effects of 1,25-dihydroxyvitamin D3 on immune reactivity towards type 2 immunity. - N/A |
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Date of first enrolment:
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15/11/2006 |
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Target sample size:
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24 |
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Recruitment status: |
complete |
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URL:
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http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=796 |
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Study type:
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intervention |
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Study design:
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Randomised: Yes; Masking: Double; Control: Placebo; Group: Parallel; Type: 2 or more arms, randomized
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Countries of recruitment
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The Netherlands
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Contacts
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Name:
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E.M.W.
Eekhoff |
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Address:
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VU University Medical Center
De Boelelaan 1118
1081 HV
Amsterdam
The Netherlands |
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Telephone:
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+31(0)20 4440533 |
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Email:
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emw.eekhoff@vumc.nl |
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Affiliation:
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Name:
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C.M.
Dinkgreve |
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Address:
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VU University Medical Center, Department of endocrinology
De Boelelaan 1118
1081 HV
Amsterdam
The Netherlands |
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Telephone:
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+31(0)20 4440533 |
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Email:
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cm.dinkgreve@vumc.nl |
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Affiliation:
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Key inclusion & exclusion criteria
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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.
Age minimum:
Age maximum:
Gender:
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Health Condition(s) or Problem(s) studied
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Auto-immune diseases
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Intervention(s)
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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.
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Primary Outcome(s)
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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.
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Secondary Outcome(s)
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We expect the type 1 cytokines to be decreased and the type 2 cytokines to be upregulated.
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Secondary ID(s)
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2006/160
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ISRCTN12365646
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Source(s) of Monetary Support
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Medicina Interna
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