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

ISRCTN ISRCTN12365646
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

VU University Medical Centre
Department of Endocrinology
De Boelelaan 1118
Amsterdam
1081 HV
Netherlands

Phone +31(0)20 444 0533
Email cm.dinkgreve@vumc.nl

Study information

Study designRandomised, placebo controlled, parallel group, double blinded trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Not specified
Study typeTreatment
Scientific title
Study objectivesShort 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) studiedAuto-immune diseases
InterventionTwelve 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 typeDrug
Pharmaceutical study type(s)
PhaseNot Specified
Drug / device / biological / vaccine name(s)Calcitriol
Primary outcome measureWe 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 measuresWe expect the type one cytokines to be decreased and the type two cytokines to be upregulated.
Overall study start date15/11/2006
Completion date15/03/2007

Eligibility

Participant type(s)Patient
Age groupAdult
SexFemale
Target number of participants24
Key inclusion criteria1. Written informed consent
2. Women, aged 20 to 30 years
3. Use of oral contraception with estrogen and progestin
4. Apparently healthy
Key exclusion criteria1. 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 enrolment15/11/2006
Date of final enrolment15/03/2007

Locations

Countries of recruitment

  • Netherlands

Study participating centre

VU University Medical Centre
Amsterdam
1081 HV
Netherlands

Sponsor information

VU University Medical Center (The Netherlands)
Hospital/treatment centre

Department of Endocrinology
De Boelelaan 1118
Amsterdam
1081 HV
Netherlands

Website http://www.vumc.nl/
ROR logo "ROR" 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
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan