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临床试验/NCT01158560
NCT01158560已完成3 期

McFlu2 COLD3 Prevention: A Randomized, Placebo-controlled, Double Blind Trial of Vitamin D and Health Advice for the Prevention of Upper Respiratory Tract Infections in McMaster University Students

St. Joseph's Healthcare Hamilton1 个研究点 分布在 1 个国家目标入组 600 人开始时间: 2010年9月1日最近更新:
适应症
干预措施

试验速览

阶段
3 期
状态
已完成
入组人数
600
试验地点
1
主要终点
The number of individuals with self-reported URTI in each of the intervention and control groups

研究概览

简要总结

The specific objectives of this investigation are to assess the effectiveness of daily gargling and vitamin D supplementation as preventative measures against incident upper respiratory tract infection (URTI) in students attending McMaster University. Investigators hypothesize that

  1. Vitamin D3 supplementation will decrease the incidence of symptomatic upper respiratory tract infections in university students
  2. Gargling will decrease the incidence of symptomatic upper respiratory tract infections in university students.

详细描述

In the current study, we propose investigating the roles of vitamin D supplementation and of regular gargling to prevent URTI/ILI. Vitamin D may be an important factor in respiratory health. Observational studies have associated low serum 25(OH)D levels with more frequent and more severe respiratory infections. However, evidence is lacking that replacement of vitamin D decreases respiratory infections. Four interventional studies of vitamin D supplementation have noted a reduction in respiratory infections, with an estimated 5-25% reduction, but results were not statistically significant.

In Japanese populations, gargling has been found to significantly reduce the incidence of upper respiratory tract infections by approximately 35% (Satomura et al., 2005). This intervention has not been studied in different populations but may be a useful personal practice to reduce URTI.

We propose a 2X2 factorial, randomized, placebo-controlled trial of vitamin D/placebo and gargling/no gargling to study the effects of vitamin D supplementation and gargling on upper respiratory tract infections in McMaster students. This study will be conducted over two years, during September and October of each study year, to capture the natural peak in rhinovirus activity.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Factorial
主要目的
Prevention
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
17 Years 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •Current or part-time student at McMaster University
  • •17 year of age or older
  • •Currently living:
  • •i. In residence or, ii. Off-campus with at least one student housemate
  • •Willing and able to sign an informed consent

排除标准

  • •Students who do not meet the inclusion criteria
  • •Currently living at home with parents
  • •History or diagnosis of hypercalcemia
  • •Diagnosis of parathyroid disorder (hyper or hypo)
  • •Diagnosis of chronic kidney disease
  • •Use of anticonvulsants
  • •Malabsorption syndromes
  • •Diagnosis of sarcoidosis
  • •Currently pregnant or planning a pregnancy
  • •Inability to swallow capsules

研究组 & 干预措施

Vitamin D and gargling

Experimental

Participants will be given a weekly dose of 10,000 IU of vitamin D3 (oral capsule) and asked to gargle with tap water twice daily

干预措施: Gargling (Behavioral)

Placebo and general health advice

Placebo Comparator

Participants will be given an aesthetically matched placebo capsule to take once weekly and will be given general health advice in place of gargling advice.

干预措施: Placebo (Dietary Supplement)

Placebo and gargling

Placebo Comparator

Participants will be given an aesthetically matched placebo capsule to take once weekly and will be asked to gargle with tap water twice daily

干预措施: Gargling (Behavioral)

Placebo and gargling

Placebo Comparator

Participants will be given an aesthetically matched placebo capsule to take once weekly and will be asked to gargle with tap water twice daily

干预措施: Placebo (Dietary Supplement)

Vitamin D and general health advice

Experimental

Participants will be given a weekly dose of 10,000 IU of vitamin D3 (oral capsule) and will receive general health advice in place of gargling advice

干预措施: cholecalciferol (vitamin D3) (Dietary Supplement)

Vitamin D and gargling

Experimental

Participants will be given a weekly dose of 10,000 IU of vitamin D3 (oral capsule) and asked to gargle with tap water twice daily

干预措施: cholecalciferol (vitamin D3) (Dietary Supplement)

结局指标

主要结局

The number of individuals with self-reported URTI in each of the intervention and control groups

时间窗: Over the course of 8 weeks spanning September and October

次要结局

  • The severity of symptoms in each of the intervention and control groups(Symptoms will be monitored daily for 7 days and a follow-up survey will be administered at day 14)
  • Duration of symptoms in each of the intervention and control groups(Symptoms will be monitored daily for 7 days and a follow-up survey will be administered at day 14)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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