The effects of low dose 1,25-dihydroxyvitamin D3 on the polarising of cellular immune reactivity towards type two immunity
ISRCTN | ISRCTN12365646 |
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DOI | https://doi.org/10.1186/ISRCTN12365646 |
Secondary identifying numbers | 2006/160 |
- Submission date
- 28/12/2006
- Registration date
- 28/12/2006
- Last edited
- 06/09/2011
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Haematological Disorders
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr C M Dinkgreve
Scientific
Scientific
VU University Medical Centre
Department of Endocrinology
De Boelelaan 1118
Amsterdam
1081 HV
Netherlands
Phone | +31(0)20 444 0533 |
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cm.dinkgreve@vumc.nl |
Study information
Study design | Randomised, placebo controlled, parallel group, double blinded trial |
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Primary study design | Interventional |
Secondary study design | Randomised controlled trial |
Study setting(s) | Not specified |
Study type | Treatment |
Scientific title | |
Study objectives | Short term oral low dose 1,25-dihydroxyvitamin D3 (1,25(OH)2D3) in man will increase type-two and decrease type-one cellular immune reactivity without affecting serum calcium levels. Hereby, the potential usage of 1,25(OH)2D3 for immuno-therapeutical approaches will be investigated. |
Ethics approval(s) | Ethics approval received from the local medical ethics committee |
Health condition(s) or problem(s) studied | Auto-immune diseases |
Intervention | Twelve volunteers will receive ten capsules of 0.5 µg calcitriol, the other twelve volunteers will receive ten capsules of placebo. They have to take the medication twice a day during five days. |
Intervention type | Drug |
Pharmaceutical study type(s) | |
Phase | Not Specified |
Drug / device / biological / vaccine name(s) | Calcitriol |
Primary outcome measure | 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 one T lymphocytes involved in auto-immune diseases. Their activity will be measured by the decrease of interferon gamma production. |
Secondary outcome measures | We expect the type one cytokines to be decreased and the type two cytokines to be upregulated. |
Overall study start date | 15/11/2006 |
Completion date | 15/03/2007 |
Eligibility
Participant type(s) | Patient |
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Age group | Adult |
Sex | Female |
Target number of participants | 24 |
Key inclusion criteria | 1. Written informed consent 2. Women, aged 20 to 30 years 3. Use of oral contraception with estrogen and progestin 4. Apparently healthy |
Key exclusion criteria | 1. Men 2. Pregnancy 3. Smoking 4. Alcohol abuse: more than 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 more than 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 |
Date of first enrolment | 15/11/2006 |
Date of final enrolment | 15/03/2007 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
VU University Medical Centre
Amsterdam
1081 HV
Netherlands
1081 HV
Netherlands
Sponsor information
VU University Medical Center (The Netherlands)
Hospital/treatment centre
Hospital/treatment centre
Department of Endocrinology
De Boelelaan 1118
Amsterdam
1081 HV
Netherlands
Website | http://www.vumc.nl/ |
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https://ror.org/00q6h8f30 |
Funders
Funder type
Not defined
Not provided at time of registration
No information available
Results and Publications
Intention to publish date | |
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Individual participant data (IPD) Intention to share | No |
IPD sharing plan summary | Not provided at time of registration |
Publication and dissemination plan | Not provided at time of registration |
IPD sharing plan |