Contact information
Type
Scientific
Primary contact
Dr C M Dinkgreve
ORCID ID
Contact details
VU University Medical Centre
Department of Endocrinology
De Boelelaan 1118
Amsterdam
1081 HV
Netherlands
+31(0)20 444 0533
cm.dinkgreve@vumc.nl
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
2006/160
Study information
Scientific title
Acronym
Study hypothesis
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
Ethics approval received from the local medical ethics committee
Study design
Randomised, placebo controlled, parallel group, double blinded trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Condition
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 names
Calcitriol
Primary outcome measures
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 trial start date
15/11/2006
Overall trial end date
15/03/2007
Reason abandoned
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Female
Target number of participants
24
Participant 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
Recruitment start date
15/11/2006
Recruitment end date
15/03/2007
Locations
Countries of recruitment
Netherlands
Trial participating centre
VU University Medical Centre
Amsterdam
1081 HV
Netherlands
Sponsor information
Organisation
VU University Medical Center (The Netherlands)
Sponsor details
Department of Endocrinology
De Boelelaan 1118
Amsterdam
1081 HV
Netherlands
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Not defined
Funder name
Not provided at time of registration
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary