NCT01131858已完成1 期
A Placebo Controlled Double Blinded Study of Vitamin D3 Substitution to Patients With Primary Immunodeficiency
Karolinska University Hospital1 个研究点 分布在 1 个国家目标入组 140 人开始时间: 2010年3月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 140
- 试验地点
- 1
- 主要终点
- Infectious score
研究概览
简要总结
Hypothesis: Cholecalciferol (vitamin D3) prevent respiratory tract infections in patients with primary immunodeficiency.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18-75
- •Increased number of respiratory tract infections
- •At least 42 days of infections during 2008 or 2009
- •S-25 OH vitamin D3 < 250 nM
- •Not planning a pregnancy during the coming year
- •Accepting the use of contraceptives during 1 year
排除标准
- •Continuous antibiotic treatment
- •Hypercalcemia
- •Sarcoidosis
- •Kidney disease
- •Tuberculosis
- •Pregnancy
- •Kidney stone
- •Heart medication (glycosides)
研究组 & 干预措施
Placebo
Placebo Comparator
Placebo
干预措施: Placebo (Drug)
Vitamin D
Active Comparator
Vigantol (cholecalciferol) 4000 IE/day
干预措施: Vigantol (Drug)
结局指标
主要结局
Infectious score
时间窗: 12 months
次要结局
- Antimicrobial peptide expression in nasal fluid(12 months)
- Serum levels of 25-OH Vitamin D3(12 months)
- Consumption of antibiotics(12 months)
- Number of positive bacterial cultures in nasal swabs(12 months)
研究者
Peter Bergman
MD, PhD
Karolinska University Hospital
研究点 (1)
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