Cholecalciferol Intervention to Prevent Respiratory Infections Study: a Double-blind Randomised Controlled Trial to Evaluate the Efficacy of 20,000 IU/wk Cholecalciferol in Reducing Respiratory Tract Infection in a Cohort of Healthy Young Adults
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 32
- 试验地点
- 2
- 主要终点
- Frequency of validated respiratory tract infections during study period
研究概览
简要总结
This is a feasibility double-blind randomised controlled trial in 32 participants. It evaluates the feasibility of a full trial which will examine the efficacy of weekly supplementation of cholecalciferol (vitamin D3) relative to placebo on the subsequent frequency and severity of objectively-verified symptomatic acute respiratory tract infection, overall and as a proportion of detected colonisations of the upper respiratory tract by 9 of the most common aetiologic viral pathogens.
详细描述
The hypotheses of the full study are:
Primary The group treated with vitamin D3 will have a significantly lower frequency of symptomatic respiratory tract infections than controls.
Secondary
- Among persons with detected viral colonisations of the nasopharynx, treated persons will have a lower frequency of symptomatic respiratory tract infection resultant than controls.
- Treated group will have significantly less severe symptomatic RTIs than controls.
- Treated group will have significantly shorter symptomatic RTI durations than controls.
For the pilot, a cohort of 32 healthy young adults satisfying inclusion criteria will be randomised to cholecalciferol supplement or identical placebo and evaluated daily for the occurrence of RTI symptoms and evaluated weekly for the presence of respiratory colonisation by relevant pathogens using nasopharyngeal swab and polymerase chain reaction using selected pathogen-specific primers. This pilot will demonstrate the logistic feasibility of the proposed study design and provide preliminary data which will inform a larger study to be undertaken next year.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Students undertaking study at the MS1 building of University of Tasmania Medical Sciences Precinct (17 Liverpool St Hobart TAS) for the full duration between May and September 2012
排除标准
- •Persons who have used tobacco within the 6 months preceding study entry
- •Persons who have used any vitamin D (cholecalciferol or ergocalciferol) supplements or calcium supplements within the 3 months preceding study entry and/or persons who refuse to not start taking any such supplement during the study
- •Persons using any immunomodulatory medication, diuretic medication, antiepileptic medication, or barbiturates.
- •Persons who presently have been diagnosed with any chronic infectious disease (e.g. HIV, tuberculosis), chronic immune deficiency or autoimmune condition, or respiratory condition (e.g. asthma, chronic obstructive pulmonary disease).
- •Persons who are hypersensitive to vitamin D.
结局指标
主要结局
Frequency of validated respiratory tract infections during study period
时间窗: 17 weeks
Frequency of validated respiratory tract infections during study period. Acute respiratory tract infections defined by respiratory symptoms reported by daily online survey lasting over a day and verified at exam by study nurse.
次要结局
- Proportion of colonisations leading to symptomatic respiratory tract infections(17 weeks)
- Severity of respiratory tract infections during study(17 weeks)
- Mean duration of respiratory tract infections during study(17 weeks)
- Frequency of non-respiratory tract infections during study(17 weeks)
- Concentration of serum 25-hydroxyvitamin D by the end of the study(17 weeks)
研究者
Dr Steve Simpson, Jr.
Postdoctoral Research Associate
Menzies Institute for Medical Research