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临床试验/NCT01999907
NCT01999907已完成2 期

Vitamin D vs. Placebo in the Prevention of Viral-induced Exacerbations in Preschoolers With Asthma: a Pilot RCT

St. Justine's Hospital2 个研究点 分布在 1 个国家目标入组 22 人开始时间: 2013年11月1日最近更新:
适应症

试验速览

阶段
2 期
状态
已完成
发起方
入组人数
22
试验地点
2
主要终点
serum Vitamin D

研究概览

简要总结

Viral infections are the main cause of asthma attacks in preschoolers, an age group with the highest rate of emergency visits due to asthma. While high doses of inhaled or oral corticosteroids provide benefits, these have been associated with adverse outcomes. Most asthmatic children have lower blood levels of vitamin D compared to non-asthmatic children. Low vitamin D level has been linked to more frequent and more severe asthma attacks as well as with higher dose requirement of inhaled corticosteroid. Recent studies show that vitamin D supplements can reduce the number of asthma attacks triggered by viral infections in children. Unfortunately, most people forget to take vitamin D every day during the fall and winter season as recommended in Canada. A solution is to give a vitamin D bolus by mouth. This has been shown to safely and effectively increase vitamin D levels in children. The investigators hypothesise that a vitamin D bolus given in clinic will sufficiently increase the blood level of vitamin D to prevent the expected winter decline in vitamin D, compared with placebo in preschool-aged children with asthma. This six-month pilot randomized controlled trial aims to: (1) show that a vitamin D bolus is superior to placebo in raising vitamin D levels; (2) record the number of asthma attacks and viral infections in enrolled participants; and (3) identify problems that may call for protocol changes.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Triple (Participant, Care Provider, Investigator)

入排标准

年龄范围
1 Year 至 5 Years(Child)
性别
All
接受健康志愿者

入选标准

  • children aged 1-5 years
  • physician-diagnosed asthma as per GINA guidelines
  • upper respiratory tract infections as the main asthma exacerbation trigger
  • ≥4 respiratory infections in the past 12 months
  • ≥1 exacerbation requiring rescue oral steroids in the past 6 months or ≥2 in the previous 12 months.

排除标准

  • extreme prematurity (<28 weeks gestation)
  • infants <12 months of age
  • breastfed infants with no vitamin D supplementation
  • recent (<1 year) immigrants from countries where rickets and malnutrition prevalent
  • other chronic respiratory disease (broncho-pulmonary dysplasia; cystic fibrosis)
  • endocrine disorder of calcium/ vitamin D metabolism
  • disorder/ disease with associated malabsorption (inflammatory bowel disease)
  • kidney/ liver disease
  • sickle cell anemia
  • medications known to interfere with bone metabolism/ vitamin D levels
  • vitamin D supplementation >1000 IU/ day in past 3 months
  • unable to attend medical visit in 3-4 months
  • plan to leave the province during the next 6 months.

结局指标

主要结局

serum Vitamin D

时间窗: 3 months

mean change in serum vitamin D from baseline to 3 months

次要结局

  • adequate serum vitamin D(3 months)

研究者

发起方
St. Justine's Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Professor Francine Ducharme

Professor & Pediatrician

St. Justine's Hospital

研究点 (2)

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