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
Protocol serial number	2006/160
Sponsor	VU University Medical Center (The Netherlands)
Funder	Not provided at time of registration

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

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

Primary study design	Interventional
Study design	Randomised, placebo controlled, parallel group, double blinded trial
Secondary study design	Randomised controlled trial
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
Phase	Not Specified
Drug / device / biological / vaccine name(s)	Calcitriol
Primary outcome measure(s)	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.
Key secondary outcome measure(s)	We expect the type one cytokines to be decreased and the type two cytokines to be upregulated.
Completion date	15/03/2007

Participant type(s)	Patient
Age group	Adult
Sex	Female
Target sample size at registration	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

VU University Medical Centre

Amsterdam
1081 HV
Netherlands

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan