NCT04368520撤回2 期
Clinical Trial to Optimise Levels of Vitamin D for Rhinovirus Protection (COLD)
适应症
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 试验地点
- 2
- 主要终点
- Rhinovirus titres
研究概览
简要总结
A phase II randomised, placebo-controlled trial to identify the optimal regimen of vitamin D supplementation for rhinovirus protection, determined by host responses to a clinically induced rhinovirus challenge. The primary outcome is rhinovirus titre after inoculation with rhinovirus; secondary outcomes are self-reported respiratory symptom scores, concentrations of cytokines and chemokines sampled from the nasal mucosa, and the transcriptional responses of nasal epithelial cells.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 18-70 years
- •Gives written informed consent
- •Serum 25-hydroxyvitamin D concentration <75 nmol/L
- •Agrees not to take supplement containing vitamin D during participation
- •Agrees not to commence smoking or vaping during participation
- •Exclusion criteria:
- •Current smoker or vaper
- •Taken vitamin D supplement or other supplement containing vitamin D, in previous 3 months
- •Sunny holiday abroadI, defined as any location 51 degrees North/South of the equator, for ≥1 week, in the previous 3 months
- •Dependent(s) <6 months old
- •Positive serology for anti-RV16 antibodies
- •Living with someone with severe airways disease
- •Any of the following medical conditions:
- •Diabetes mellitus
- •Chronic Obstructive Pulmonary Disease
- •Respiratory allergies
- •Sarcoidosis
- •Hyperparathyroidism
- •Nephrolithiasis
- •Active tuberculosis
- •Liver failure
- •Renal failure
- •Lymphoma or other malignancy not in remission for ≥ 3 years
排除标准
- 未提供
结局指标
主要结局
Rhinovirus titres
时间窗: +3 to +5 days after inoculation
PCR-detected rhinovirus-16 load sampled from the nasal mucosa
次要结局
- Respiratory symptom score (Jackson Score)(+1 to +14 days after inoculation)
- Cytokine and chemokine concentrations(Day 0 and +4 days after inoculation)
- Change in level of vitamin D-regulated gene expression(Day 0 and +4 days after inoculation)
研究者
研究点 (2)
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