Impact of Vitamin D Supplementation on Recurrent Respiratory Infections in Paediatric
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 84
- 主要终点
- Number of recurrent respiratory tract infections for each months of study
研究概览
简要总结
Up to date, some clinical trial have evaluated the efficacy and safety of Vitamin D supplementation in children with RRI, with no conclusive information.
Therefore, the investigators designed a prospective, single-blind, clinical trial to evaluate whether oral supplementation with vitamin D from October to April reduces the global health burden of recurrent respiratory tract infections in a primary care setting.
The primary outcome was evaluated if Vitamin D supplementation during autumn and winter can reduce the number of respiratory tract infections in children diagnosed with recurrent respiratory tract infections the seasons before.
Secondary objectives was the assessment of Vitamin D supplementation benefits on global socioeconomic burden of recurrent respiratory tract infections in a primary care setting, according to number of visits to the primary care paediatrician and use of antibiotics due to respiratory tract infections.
详细描述
The University study personnel randomly allocated patients to receive, from October to March, a Vitamin D oral supplementation (400 UI/die up to 12 month or 600 UI/die beyond 1 year) or not.
Randomization was performed using a free web-based service that offers random assignment; patients were randomized considering gender and age class (up to 12 months; beyond 1 years). The primary care practitioner was blinded regarding the study group allocation.
Inclusion criteria were: a) patients diagnosed the seasons before with: ≥ 6 respiratory infections per annum OR ≥ 1 respiratory infections per month involving the upper airways from September to April OR ≥ 3 respiratory infections per annum involving the lower airways. b) patients with no findings suggestive of an immunodeficiency on history and physical examination.
From the recruitment, parents recorded number and type of diagnosed respiratory tract infections, number of ambulatory visits, use of antibiotics and duration of symptoms in a structured diary.
Upper Respiratory Tract Infections (URTIs) comprehends diagnosis of acute otitis media, acute rhinosinusitis and acute pharyngotonsillitis. Lower Respiratory Tract Infections (LRTIs) comprehend diagnosis of bronchiolitis and pneumonia.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 6 Months 至 3 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients diagnosed the seasons before with: ≥ 6 respiratory infections per annum
- •≥ 1 respiratory infections per month involving the upper airways from September to April
- •≥ 3 respiratory infections per annum involving the lower airways
排除标准
- •patients with findings suggestive of an immunodeficiency on history and physical examination
研究组 & 干预措施
Vit D
Vitamin D oral supplementation (400 UI/die up to 12 month or 600 UI/die beyond 1 year) from October to March
干预措施: Vitamin D3 (Drug)
结局指标
主要结局
Number of recurrent respiratory tract infections for each months of study
时间窗: From October 1, 2014, and March 31, 2015, up to 6 months
reduction of the number of respiratory tract infections in children diagnosed with recurrent respiratory tract infections the seasons before
次要结局
- Cost assessment in euros according to antibiotics, paediatric visits and vitamin D supplementation(From October 1, 2014, and March 31, 2015, up to 6 months)
研究者
Prof. Maria Elisabetta Baldassarre
MD
Policlinico Hospital