Vitamin D Supplementation in Polymorphic Light Eruption

NCT01595893 | Terminated Phase 3

• 1 other identifier: Graz 24-220 ex 11/12
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Polymorphic Light Eruption

Keywords

Polymorphic light eruption; Vitamin D3; Photo provocation; Immune function

Outcome Measures

Primary Outcomes (1)

• PLE test score (from 0-12) of experimental photo provocation

  See study description.

  At day 2, 3, 4, 5, and 8 (change from baseline)

Secondary Outcomes (7)

• Cytokine levels in serum

  At day 22 and 36; and at month 4-8

• Chemotaxis of neutrophils

  At day 22 and 36; and at month 4-8 (compared to baseline)

• Level of regulatory T cells

  At day 22 and 36; and at month 4-8 (compared to baseline)

• Quantification of skin alterations, including cellular infiltration and cytokine profile

  Day 5 and 40

• Dermatological quality of life (DLQI)

  At month 4-8

Study Arms (2)

Vitamin D3

EXPERIMENTAL

Drug: Oral Vitamin D 3

Placebo

PLACEBO COMPARATOR

Drug: Miglyol 812 N

Interventions

Oral Vitamin D 3 DRUG

40,000 IE vitamin D3 per 70 kg body weight, given twice (2 weeks apart)

Also known as: Oleovit D3, Fresenius Kabi, Austria

Vitamin D3

Miglyol 812 N DRUG

Neutral oil of esters extracted from coconut and palm kernel

Also known as: Vegetable oil

Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Confirmed diagnosis of PLE by typical patient history, typical histology of skin lesions and/or positive photo provocation results

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Medical University of Graz: lead
• Austrian Science Fund (FWF): collaborator

Study Sites (1)

Medical University of Graz, Department of Dermatology

Graz, A-8036, Austria

Location

Related Publications (1)

• Schweintzger NA, Gruber-Wackernagel A, Shirsath N, Quehenberger F, Obermayer-Pietsch B, Wolf P. Influence of the season on vitamin D levels and regulatory T cells in patients with polymorphic light eruption. Photochem Photobiol Sci. 2016 Mar;15(3):440-6. doi: 10.1039/c5pp00398a. Epub 2016 Feb 25.

  PMID: 26911519 DERIVED

MeSH Terms

Interventions

Cholecalciferol; Plant Oils

Intervention Hierarchy (Ancestors)

Cholestenes; Cholestanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Sterols; Vitamin D; Secosteroids; Membrane Lipids; Lipids; Oils; Plant Preparations; Biological Products; Complex Mixtures

Study Officials

• Peter Wolf, MD

  Medical University of Graz

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 26, 2012
• First Posted: May 10, 2012
• Study Start: April 1, 2012
• Primary Completion: May 1, 2015
• Study Completion: May 1, 2015
• Last Updated: June 13, 2016

Record last verified: 2016-06

Locations

AU (1)