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临床试验/NCT01419262
NCT01419262已完成3 期

DO IT Trial: Vitamin D Outcomes and Interventions In Toddlers

The Hospital for Sick Children2 个研究点 分布在 1 个国家目标入组 703 人开始时间: 2011年9月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
3 期
状态
已完成
入组人数
703
试验地点
2
主要终点
Number of Laboratory confirmed upper respiratory tract infections

研究概览

简要总结

Vitamin D can be made in the skin by exposure to sunlight and can be found in certain foods. Vitamin D levels are alarmingly low in many North American children. Several health issues have been linked with low vitamin D. These include colds caused by viruses and asthma attacks. However, no study has determined whether vitamin D supplementation can reduce the risk of these conditions in young children where they are most common and most severe.

The goals of this study are to determine whether wintertime high dose vitamin D supplementation of preschoolers can prevent colds and asthma attacks. The investigators also aim to work out how much money would be saved by the health care system and society if preschoolers were routinely supplemented with Vitamin D during the winter. The investigators believe that preschoolers receiving 'high dose' vitamin D supplementation during the wintertime will be less likely to have colds, asthma attacks, and low vitamin D levels and will be less likely to use the medical system and keep their parents away from work.

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

入选标准

  • Healthy children by parental report
  • Have reached their 1st birthday but not past their 6th birthday
  • Present to a TARGet Kids! practice for routine primary healthcare prior to viral season (September through November)
  • Parents provide informed consent to participate.

排除标准

  • Children with gestational age < 32 weeks
  • Children with chronic illness (except for asthma) on parental report which is known to interfere with vitamin D metabolism and increase the risk of respiratory infection
  • Children with a sibling participating in the study to reduce clustering effects.

研究组 & 干预措施

2000 IU per day vitamin D

Experimental

干预措施: Vitamin D3 - Cholecalciferol 2000 IU (Drug)

400 IU per day vitamin D

Active Comparator

干预措施: Vitamin D - Cholecalciferol 400 IU (Drug)

结局指标

主要结局

Number of Laboratory confirmed upper respiratory tract infections

时间窗: Up to 8 months

Parents of enrolled children will be asked to obtain a nasal swab from their child and complete a symptom checklist with each URTI. Reverse transcriptase polymerase chain reaction will be performed on each sample. Samples will be tested for 18 common respiratory viruses using the ID-TagTM RVP assay using the Luminex xMAPTM system.

次要结局

  • Number of parent reported upper respiratory tract infections(Up to 8 months)
  • Direct and indirect economic costs associated with upper respiratory tract infections(16 months)
  • Number of Asthma exacerbations(Up to 8 months)
  • Serum vitamin D level(5-8months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Jonathon L Maguire

Physician/ Principal Investigator

The Hospital for Sick Children

研究点 (2)

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