Condition category
Haematological Disorders
Date applied
28/12/2006
Date assigned
28/12/2006
Last edited
06/09/2011
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

http://www.vumc.nl/

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

Publication citations

Additional files

Editorial Notes