NCT01466465已完成2 期
Vitamin D and Grass Pollen Specific Immunotherapy
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 35
- 试验地点
- 1
- 主要终点
- wheal diameter in the intradermal test after SIT in the comparison between vitamin D and placebo
研究概览
简要总结
Allergen-specific immunotherapy is the only causal therapy of Immunoglobulin E-induced allergies like allergic rhinoconjunctivitis. Despite progress during the last decades it is limited by a long treatment time and high non-responder frequency. Based on experimental and epidemiological evidences we hypothesize that vitamin D can act as an effective immunomodulatory adjuvant to overcome these limitations.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •written informed consent
- •relative Vitamin D deficiency
- •clinical relevant grass pollen allergy
- •positive intradermal test with grass pollen
- •forced expiratory volume at one second (FEV1) > 70%
排除标准
- •current specific immunotherapy
- •instable allergic asthma
- •pregnancy and lactation
- •treatment with immunomodulators or immunosuppressive drugs
- •sarcoidosis, chronic diseases, malignancy
研究组 & 干预措施
Vigantol
Experimental
干预措施: Cholecalciferol (Drug)
neutral oil (vigantol carrier)
Placebo Comparator
干预措施: middle-chain fatty acids (carrier) (Other)
结局指标
主要结局
wheal diameter in the intradermal test after SIT in the comparison between vitamin D and placebo
时间窗: three years
次要结局
未报告次要终点
研究者
Margitta Worm
Prof. Dr. med.
Charite University, Berlin, Germany
研究点 (1)
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