Vitamin D Supplementation in Polymorphic Light Eruption (VitD-PLE_2012)

June 10, 2016 updated by: Medical University of Graz

Vitamin D3 Supplementation in Polymorphic Light Eruption: Randomized Double-blinded Placebo-controlled Trial

Polymorphic light eruption (PLE) is a common photodermatosis with a high prevalence of approximately 11 to 21% in the population. Similar to lupus erythematosus (LE), an UV-inducible systemic autoimmune disease, PLE has a female preponderance with a mean onset in the second to third decade of life. PLE lesions are very itchy and typically appear on sun-exposed body sites in spring or early summer. The quality of life in patients with PLE is often severely disturbed, as evidenced by high levels of anxiety and depression. For prophylaxis besides conventional sunscreens, photo(chemo)therapy is effective in many cases, when administered over several weeks for hardening in early spring before the first natural sun exposure takes place. However, because prolonged treatment with UVB and/or photochemotherapy is potentially carcinogenic, the search for pathogenic mechanisms and new treatment options in PLE is ongoing. The exact pathogenesis of PLE is currently unknown but findings suggest an autoimmune-type background with resistance to UV-induced immune suppression and simultaneous immune reactions against skin photo-neoantigens. The investigators have recently found that PLE patients had significantly reduced 1,25-(OH)2-vitamin D3 serum levels (13-14ng/ml) compared to the normal population (>30ng/ml). In addition, the investigators were able to demonstrate in an intra-individual half-body trial that topical administration of an immunostimulatory 1,25-(OH)2-vitamin-D3 analogue calcipotriol reduced PLE symptoms in an experimental study. In the proposed randomized double-blinded placebo-controlled trial the investigators attempt to study the effect of oral vitamin D3 supplementation (2 x 40.000 IE, given orally two weeks apart) on PLE symptoms.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

8

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Graz, Austria, A-8036
        • Medical University of Graz, Department of Dermatology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Drug: Miglyol 812 N
Neutral oil of esters extracted from coconut and palm kernel
Other Names:
  • Vegetable oil
Experimental: Vitamin D3
Drug: Oral Vitamin D 3
40,000 IE vitamin D3 per 70 kg body weight, given twice (2 weeks apart)
Other Names:
  • Oleovit D3, Fresenius Kabi, Austria

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
At day 2, 3, 4, 5, and 8 (change from baseline)

Secondary Outcome Measures

Outcome Measure
Time Frame
Cytokine levels in serum
Time Frame: At day 22 and 36; and at month 4-8
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)
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)
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
Day 5 and 40
Dermatological quality of life (DLQI)
Time Frame: At month 4-8
At month 4-8
HADS (hospital anxiety and depression scale)
Time Frame: At month 4-8
At month 4-8
Function of regulatory T cells
Time Frame: 22 and 36; and at month 4-8 (compared to baseline)
22 and 36; and at month 4-8 (compared to baseline)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical University of Graz

Collaborators

Austrian Science Fund (FWF)

Investigators

  • Principal Investigator: Peter Wolf, MD, Medical University of Graz

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2012

Primary Completion (Actual)

May 1, 2015

Study Completion (Actual)

May 1, 2015

Study Registration Dates

First Submitted

April 26, 2012

First Submitted That Met QC Criteria

May 9, 2012

First Posted (Estimate)

May 10, 2012

Study Record Updates

Last Update Posted (Estimate)

June 13, 2016

Last Update Submitted That Met QC Criteria

June 10, 2016

Last Verified

June 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Graz 24-220 ex 11/12

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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