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 individuals 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
Serum Provitamin D kinetic upon oral intake: an open label dose escalation study
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 Committee of Charité, Universitätsmedizin Berlin (Germany), 19 November 2008, ref: EA1-151-08
Amendments approved on 10 May 2010
Open label dose-escalation trial
Primary study design
Secondary study design
Non randomised controlled trial
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Vitamin D supplementation
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
Primary outcome measure
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
Overall trial end date
Reason abandoned (if study stopped)
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
Target number of participants
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
7. Chronic infections
8. Planned exzessive tanning during the investigation time
Recruitment start date
Recruitment end date
Countries of recruitment
Trial participating centre
Department of Dermatology & Allergy
Charité - Universitätsmedizin Berlin (Germany)
c/o Margitta Worm
Klinik für Dermatologie
Venerologie und Allergologie
Germn Research Foundation [Deutsche Forschungsgemeinschaft (DFG)] (Germany) ref: SFB650-TP5
Funding Body Type
Funding Body Subtype
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
Basic results (scientific)