EUCTR2012-000300-15-AT进行中(未招募)1 期
Vitamin D supplementation in polymorphic light eruption: Randomized double-blinded placebo-controlled trial - Vitamin D and PLE
Medizinische Universität Graz, Univ. Klinik Dermatologie, Forschungseinheit für Photodermatologie0 个研究点开始时间: 2012年3月6日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中(未招募)
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •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
排除标准
- •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
研究者
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