Condition category
Not Applicable
Date applied
21/11/2011
Date assigned
21/12/2011
Last edited
04/12/2012
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims:
Vitamin D deficiency is associated with allergy and autoimmune diseases. However, long-term treatment of patients with allergies with vitamin D (calcitriol) is limited, as large doses can be toxic. Activated immune cells can, however, create their own calcitriol. We want to investigate how we can target these cells to stimulate calcitriol production.

Who can participate?
Healthy individuals and patients with autoimmunity or allergy between 18-60 years.

What does the study involve?
One groups will receive vitamin D, and the other group will not. A control cohort will not receive vitamin D. The group that does, will have monthly increases in doses of daily vitamin D intake. Blood samples will be take twice a month to assess each individual’s vitamin D status and to monitor immune cells.

What are the possible benefits and risks of participating?
Participants will be supporting academic medical research. Risks of taking part in the study include vitamin D intoxication which can cause nausea and weakness. There is also risk of bruising after blood samples are taken, however this should be minimised as only experienced staff will be taking samples.

Where is the study run from?
Department of Dermatology, Venereology and Allergology at the Charité in Berlin, Germany

When is the study starting and how long is it expected to run for?
Recruitment for the study started in December 2009 and ended in December 2010. The study period was for 4 months, and ended in May 2011.

Who is funding the study?
German Research Foundation [Deutsche Forschungsgemeinschaft (DFG)] ref: SFB650-TP5.

Who is the main contact?
Prof Margitta Worm
margitta.worm@charite.de

Trial website

Contact information

Type

Scientific

Primary contact

Dr Guido Heine

ORCID ID

Contact details

Department of Dermatology & Allergy
Charité - Universitätsmedizin Berlin
Chariteplatz 1
Berlin
10117
Germany

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

Prokin D

Study information

Scientific title

Serum Provitamin D kinetic upon oral intake: an open label dose escalation study

Acronym

ProKin D

Study hypothesis

We suppose that serum 25-hydroxyvitamin D concentrations will be reached exceeding 100 nmol/L upon vitamin D intake in increasing dosages and maintained >50 nmol/L over 3 months after termination of vitamin D intake.

Ethics approval

Ethics Committee of Charité, Universitätsmedizin Berlin (Germany), 19 November 2008, ref: EA1-151-08
Amendments approved on 10 May 2010

Study design

Open label dose-escalation trial

Primary study design

Interventional

Secondary study design

Non randomised controlled trial

Trial setting

Hospitals

Trial type

Screening

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Vitamin D supplementation

Intervention

1. Vitamin D groups monthly increasing doses of vitamin D, in detail 2000 I.U. Daily followed by 4000 I.U. and 8000 I.U in the presence of 1 mg calcium daily
2. Controls: none

Intervention type

Supplement

Phase

Not Specified

Drug names

Vitamin D

Primary outcome measures

Achievement of serum 25-hydroxyvitamin D concentrations above 100 nM on screening visits and 4 monthly study visits

Secondary outcome measures

1. Serum concentrations of calcium, phosphorus, creatinine
2. Monitor activation and phenotype of peripheral lymphocytes

Assesed on screening visits and 4 monthly study visits

Overall trial start date

10/12/2008

Overall trial end date

01/04/2010

Reason abandoned

Eligibility

Participant inclusion criteria

1. Healthy individuals, patients with type I allergy
2. Age 18-60 years
3. No excessive tanning in last 4 weeks
4. Written informed consent

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

48

Participant exclusion criteria

1. Simultaneous participation in an other study
2. Expected incompliance
3. Pregnancy, lactation
4. Disease of the cardiovascular system, kidneys, thyroid gland
5. Malignant diseases
6. Malabsorbtion
7. Chronic infections
8. Planned exzessive tanning during the investigation time

Recruitment start date

10/12/2008

Recruitment end date

01/04/2010

Locations

Countries of recruitment

Germany

Trial participating centre

Department of Dermatology & Allergy
Berlin
10117
Germany

Sponsor information

Organisation

Charité - Universitätsmedizin Berlin (Germany)

Sponsor details

c/o Margitta Worm
Klinik für Dermatologie
Venerologie und Allergologie
Allergie-Centrum-Charité
CCM
Charitéplatz 1
Berlin
10117
Germany

Sponsor type

University/education

Website

http://www.charite.de/en/charite/

Funders

Funder type

Government

Funder name

Germn Research Foundation [Deutsche Forschungsgemeinschaft (DFG)] (Germany) ref: SFB650-TP5

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