The Pharmacogenetics of Vitamin D Supplementation in Tuberculosis
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 62
- 试验地点
- 2
- 主要终点
- Change in post supplementation vitamin D level
研究概览
简要总结
Previous studies of vitamin D supplementation have suggested there may be differences in response between individuals. This study is an open label study of vitamin D supplementation in patients with active or latent tuberculosis in which active disease patients take 100000units of vitamin D every 8 weeks during their tuberculosis treatment. Genotyping for relevant vitamin D pathway polymorphisms will be carried out and related to clinical and ex vivo markers of vitamin D response. Latent patients will only be studied for vitamin D response ex vivo. Our hypothesis is that response to vitamin D in both monocytes and T cells will be related to polymorphisms in the DBP gene, and that this may relate to clinical response in terms of post supplementation vitamin D level.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 16 or above
- •Microbiologically or histologically confirmed active tuberculosis
- •Clinically confirmed latent tuberculosis
排除标准
- •Patients being managed with regimes outside standard NICE guidance
- •Drug resistant MTb
- •HIV positive
- •Known intolerance of vitamin D
- •Sarcoidosis
- •Hyperparathyroidism or nephrolithiasis
- •Taking vitamin D supplementation in the two months preceding enrolment
- •Baseline serum corrected calcium >2.65 mmol/L
- •Current haemodialysis
- •Children, pregnant or breastfeeding individuals
- •Concomitant benzothiadiazine derivative, cardiac glycoside, carbamazepine, phenobarbital, phenytoin, primidone or long-term immunosuppressant therapy
结局指标
主要结局
Change in post supplementation vitamin D level
时间窗: 8,16 and 24 weeks
次要结局
- Ex vivo responses of monocytes to vitamin D(0 and 8 weeks)
- Ex vivo responses of T cells to vitamin D(0 and 8 weeks)
研究者
Alice Turner
Clinician Scientist and Honorary Consultant Physician
University of Birmingham