Vitamin D Supplementation in Polymorphic Light Eruption
Maneno muhimu
Kikemikali
Maelezo
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.
Tarehe
| Imethibitishwa Mwisho: | 05/31/2016 |
| Iliyowasilishwa Kwanza: | 04/25/2012 |
| Uandikishaji uliokadiriwa Uliwasilishwa: | 05/08/2012 |
| Iliyotumwa Kwanza: | 05/09/2012 |
| Sasisho la Mwisho Liliwasilishwa: | 06/09/2016 |
| Sasisho la Mwisho Lilichapishwa: | 06/12/2016 |
| Tarehe halisi ya kuanza kwa masomo: | 03/31/2012 |
| Tarehe ya Kukamilisha Msingi iliyokadiriwa: | 04/30/2015 |
| Tarehe ya Kukamilisha Utafiti: | 04/30/2015 |
Hali au ugonjwa
Uingiliaji / matibabu
Drug: Vitamin D3
Drug: Placebo
Awamu
Vikundi vya Arm
| Mkono | Uingiliaji / matibabu |
|---|---|
| Experimental: Vitamin D3 | Drug: Vitamin D3 40,000 IE vitamin D3 per 70 kg body weight, given twice (2 weeks apart) |
| Placebo Comparator: Placebo | Drug: Placebo Neutral oil of esters extracted from coconut and palm kernel |
Vigezo vya Kustahiki
| Zama zinazostahiki Kujifunza | 18 Years Kwa 18 Years |
| Jinsia Inastahiki Kujifunza | All |
| Hupokea Wajitolea wa Afya | Ndio |
| Vigezo | Inclusion Criteria: - Confirmed diagnosis of PLE by typical patient history, typical histology of skin lesions and/or positive photo provocation results Exclusion Criteria: - Allergy or intolerance to Oleovit D3 or Coconut/palm kernel - Presence or history of malignant skin tumors - Dysplastic melanocytic nevus syndrome - Photosensitive diseases such as porphyria, chronic actinic dermatitis, xeroderma pigmentosum, and basal cell nevus syndrome; autoimmune disorders such as lupus erythematosus or dermatomyositis - Sarcoid - Renal dysfunction - Psychiatric disorder - Pregnancy or breastfeeding - Topical treatment with vitamin D derivates within 3 months - Oral treatment with vitamin D within 6 months - Antinuclear antibodies such as anti-ds-DNA or anti- Ro/La - 25-hydroxy vitamin D serum levels > 30ng/ml at screening visit - Serum hypercalcemia > 2,65 nmol/L - Treatment with thiazides or glycosides - Systemic treatment with steroids and/or other immunosuppressive drugs within 4 weeks - UV exposure in test fields within 8 weeks before the start of the study - General poor health status |
Matokeo
Hatua za Matokeo ya Msingi
1. PLE test score (from 0-12) of experimental photo provocation [At day 2, 3, 4, 5, and 8 (change from baseline)]
Hatua za Matokeo ya Sekondari
1. Cytokine levels in serum [At day 22 and 36; and at month 4-8]
2. Chemotaxis of neutrophils [At day 22 and 36; and at month 4-8 (compared to baseline)]
3. Level of regulatory T cells [At day 22 and 36; and at month 4-8 (compared to baseline)]
4. Quantification of skin alterations, including cellular infiltration and cytokine profile [Day 5 and 40]
5. Dermatological quality of life (DLQI) [At month 4-8]
6. HADS (hospital anxiety and depression scale) [At month 4-8]
7. Function of regulatory T cells [22 and 36; and at month 4-8 (compared to baseline)]
