Vitamin D Supplementation in Polymorphic Light Eruption (VitD-PLE_2012)
|Polymorphic Light Eruption||Drug: Oral Vitamin D 3 Drug: Miglyol 812 N||Phase 3|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
|Official Title:||Vitamin D3 Supplementation in Polymorphic Light Eruption: Randomized Double-blinded Placebo-controlled Trial|
- PLE test score (from 0-12) of experimental photo provocation [ Time Frame: At day 2, 3, 4, 5, and 8 (change from baseline) ]See study description.
- Cytokine levels in serum [ Time Frame: At day 22 and 36; and at month 4-8 ]
- Chemotaxis of neutrophils [ Time Frame: At day 22 and 36; and at month 4-8 (compared to baseline) ]
- Level of regulatory T cells [ Time Frame: At day 22 and 36; and at month 4-8 (compared to baseline) ]
- Quantification of skin alterations, including cellular infiltration and cytokine profile [ Time Frame: Day 5 and 40 ]
- Dermatological quality of life (DLQI) [ Time Frame: At month 4-8 ]
- HADS (hospital anxiety and depression scale) [ Time Frame: At month 4-8 ]
- Function of regulatory T cells [ Time Frame: 22 and 36; and at month 4-8 (compared to baseline) ]
|Study Start Date:||April 2012|
|Study Completion Date:||May 2015|
|Primary Completion Date:||May 2015 (Final data collection date for primary outcome measure)|
|Experimental: Vitamin D3||
Drug: Oral Vitamin D 3
40,000 IE vitamin D3 per 70 kg body weight, given twice (2 weeks apart)
Other Name: Oleovit D3, Fresenius Kabi, Austria
|Placebo Comparator: Placebo||
Drug: Miglyol 812 N
Neutral oil of esters extracted from coconut and palm kernel
Other Name: Vegetable oil
PLE patients will be subjected to experimental photo provocation with solar simulated UV radiation over several days before and after vitamin D3 supplementation. Disease symptoms will be quantified with a newly established and validated PLE test score, (AA + SI + 0.4P [range, 0-12], where AA is affected area score [range, 0-4], SI is skin infiltration score [range, 0-4], and P is pruritus score on a visual analogue scale [range, 0-10]). Optional biopsies will be taken to investigate the effect of oral vitamin D3 on UV-induced skin test sites, including cellular skin infiltration and expression and release of cytokines in situ as endpoints. We will also study the effect of oral vitamin D3 on abnormalities i) of levels and function of regulatory T cells, ii) chemotaxis of leucocytes, and iii) proinflammatory cytokines, i.e. alterations that have been previously linked to PLE pathogenesis. This will be done by i) FACS and co-culture T cell proliferation assays, ii) response of peripheral neutrophil leucocytes to the chemoattractants leukotriene B4 (LTB4) and formyl-methionyl-leucyl-phenylalanine, and iii) ELISA and immunobead assay of patient serum.
To back-up the results obtained with the PLE test score upon experimental photo provocation the study participants will receive a questionnaire on PLE symptoms and quality of life, adapted from scores as previously described. This questionnaire will allow monitoring PLE symptoms and quality of life in the patients during the summer season following the oral vitamin D3 supplementation in spring.
The results of the project will enlighten the mechanism of PLE and may establish the base of a novel prevention strategy via the vitamin D3 pathway.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01595893
|Medical University of Graz, Department of Dermatology|
|Graz, Austria, A-8036|
|Principal Investigator:||Peter Wolf, MD||Medical University of Graz|