Vitamin D supplementation in polymorphic light eruption: Randomized double-blinded placebo-controlled trial - Vitamin D and PLE

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2012-000300-15-AT

Enrollment

Unknown

Registered

2012-03-06

Start date

2012-04-12

Completion date

Unknown

Last updated

2016-09-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Polymorphic light eruption MedDRA version: 14.1 Level: PT Classification code 10051246 Term: Photodermatosis System Organ Class: 10040785 - Skin and subcutaneous tissue disorders

Interventions

Trade Name: Oleovit D 3 Tropfen Pharmaceutical Form: Oral liquid INN or Proposed INN: COLECALCIFEROL CAS Number: 67-97-0 Concentration unit: IU/ml international unit(s)/millilitre Concentration type:

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: age greater than 18 years and below 75 years confirmed diagnosis of polymorphic light eruption by typical patient history and/or typical histology of skin lesions and/or positive photoprovocation results Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 36 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 10

Exclusion criteria

Exclusion criteria: Allergy or intolerance to Oleovit Vitamin D3 or Coconut presence or history of malignant skin tumors, dysplastic melanocytic nevus syndrome, photosensitive diseases such as porphyria, chronic actinic dermatitis, xeroderma pigmentosum, basal cell nevus syndrome; renal dysfunction, Sarcoid, autoimmune disorders such as lupus erythematosus or dermatomyositis, psychiatric disorders, pregnancy or breast feeding, antinuclear antibodies such as anti-ds-DNA or anti-Ro/La, topical treatment with vitamin D derivates within 3 months, oral treatment with vitamin D within 6 months, 25-OH vitamin D levels > 30 ng/ml at screening visit, 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, treatment with thiazides or glycosides, serum hypercalcemia > 2,65 nmol/l

Design outcomes

Primary

Measure	Time frame
Main Objective: To determine whether oral vitamin D supplementation abrogates the pathogenic mechanisms in PLE and prevents the manifestation of the disease.;Secondary Objective: not applicable;Primary end point(s): PLE test score of experimental photoprovocation;Timepoint(s) of evaluation of this end point: up to 3 years after start of study	—

Secondary

Measure	Time frame
Secondary end point(s): Clinical endpoints: - PLE symptoms, quality of life, and HADS upon exposure to natural sun light during spring and summer Laboratory endpoints: - Quantification of histologic alterations - Cytokine levels in serum - Level and function of regulatory T cells (Tregs) - Chemotaxis of neutrophils ;Timepoint(s) of evaluation of this end point: up to 3 years after start of study	—

Countries

Austria

Contacts

Public ContactInformation Klinische Studie

Medical University of Graz

dermatologie@medunigraz.at43316385 12538

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026