NCT01069874已完成2 期
Cluster-randomised, Double-Blind, Placebo-Controlled Trial of Vitamin D Supplementation for the Prevention of Influenza and Other Respiratory Infections in Sheltered Accommodation (ViDiFlu)
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 240
- 试验地点
- 2
- 主要终点
- Time to first respiratory tract infection (upper or lower) in sheltered accommodation residents
研究概览
简要总结
Purpose: The study null hypothesis is that vitamin D supplementation will not influence time to acute respiratory tract infection in sheltered accommodation residents.
详细描述
The study population will comprise sheltered accommodation residents and staff fulfilling eligibility criteria. Half of the sheltered accommodation schemes will be randomly allocated to 2-monthly oral bolus vitamin D supplementation (Vigantol oil) over a period of one year, and half to placebo.
Participants will be followed for one 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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- 是
入选标准
- •Permanent resident or member of staff at sheltered accommodation unit
- •If a woman of child-bearing potential, is sexually abstinent or has negative pregnancy test within 7 days of recruitment and agrees to use reliable form of contraception until she has completed the study
- •Able to give written informed consent to participate
- •Age ≥ 16 years on day of first dose of IMP
排除标准
- •Current diagnosis of asthma or chronic obstructive pulmonary disease
- •Chronic upper or lower respiratory infection or other condition causing chronic cough
- •Condition requiring treatment with vitamin D at a dose of > 10 micrograms vitamin D/day
- •Episode of upper or lower respiratory tract infection up to 28 days before first dose of IMP
- •Known sarcoidosis, hyperparathyroidism, nephrolithiasis, active tuberculosis, vitamin D intolerance, liver failure, renal failure, terminal illness, lymphoma or other malignancy not in remission at time of recruitment
- •Taking benzothiadiazine derivative, cardiac glycoside, carbamazepine, phenobarbital, phenytoin, primidone or long-term immunosuppressant therapy
- •Taking oral preparation containing > 10 micrograms vitamin D/day up to 2 months before first dose of IMP
- •Using topical vitamin D analogue
- •Treatment with any investigational medical product or device up to 4 months before first dose of IMP
- •Breastfeeding, pregnant or planning a pregnancy
- •Baseline corrected serum calcium > 2.65 mmol/L
- •Baseline serum creatinine > 125 micromol/L
- •Inability to complete symptom diary with / without assistance
- •Cognitive impairment or communication problem precluding informed consent or successful completion of study evaluations
研究组 & 干预措施
Miglyol oil
Placebo Comparator
Miglyol oil will be administered in 2-monthly oral bolus doses over a period of one year
干预措施: Miglyol oil (Dietary Supplement)
Vigantol oil
Active Comparator
Vigantol oil will be administered in 2-monthly oral bolus doses over a period of one year
干预措施: Cholecalciferol (Vitamin D/Vigantol oil) (Dietary Supplement)
结局指标
主要结局
Time to first respiratory tract infection (upper or lower) in sheltered accommodation residents
时间窗: One year
次要结局
- Time to first respiratory tract infection (upper or lower) in sheltered accommodation staff(One year)
- Annual rate of episodes of upper / lower respiratory infection in sheltered accommodation residents / staff(One year)
- Time to unscheduled health service use for respiratory tract infection in sheltered accommodation residents / staff(One year)
- Proportion of participants experiencing hypercalcaemia(One year)
研究者
研究点 (2)
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