Serum Provitamin D kinetic upon oral intake
| ISRCTN | ISRCTN65263333 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN65263333 |
| Secondary identifying numbers | Prokin D |
- Submission date
- 21/11/2011
- Registration date
- 21/12/2011
- Last edited
- 14/04/2022
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Other
Plain English summary of protocol
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
margitta.worm@charite.de
Contact information
Scientific
Department of Dermatology & Allergy
Charité - Universitätsmedizin Berlin
Chariteplatz 1
Berlin
10117
Germany
Study information
| Study design | Open label dose-escalation trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Screening |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | Serum Provitamin D kinetic upon oral intake: an open label dose escalation study |
| Study acronym | ProKin D |
| Study objectives | 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(s) | Ethics Committee of Charité, Universitätsmedizin Berlin (Germany), 19 November 2008, ref: EA1-151-08 Amendments approved on 10 May 2010 |
| Health condition(s) or problem(s) studied | 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 |
| 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 study start date | 10/12/2008 |
| Completion date | 01/04/2010 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 60 Years |
| Sex | Both |
| Target number of participants | 48 |
| Total final enrolment | 43 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 10/12/2008 |
| Date of final enrolment | 01/04/2010 |
Locations
Countries of recruitment
- Germany
Study participating centre
10117
Germany
Sponsor information
University/education
c/o Margitta Worm
Klinik für Dermatologie, Venerologie und Allergologie
Allergie-Centrum-Charité, CCM
Charitéplatz 1
Berlin
10117
Germany
| Website | http://www.charite.de/en/charite/ |
|---|---|
"ROR" |
https://ror.org/001w7jn25 |
Funders
Funder type
Government
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan | Not provided at time of registration |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | 23/01/2017 | 14/04/2022 | Yes | No |
Editorial Notes
14/04/2022: The following changes have been made:
1. Publication reference added.
2. The final enrolment number has been added from the reference.
