Impact of Vitamin D Supplementation on Recurrent Respiratory Infections in Paediatric Primary Care.
Impact of Vitamin D Supplementation on Recurrent Respiratory Infections in Paediatric
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.
調査の概要
詳細な説明
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.
All parents had a close telephone contact to help them in the diary compilation. Adverse events related to the protocol were monitored. Missing data were recovered through the information system of the primary care practitioner.
Quantitative data were expressed as mean and standard deviation. To compare the mean between the two groups, Student's t-test for unpaired was used. The frequency of each visits to the pediatricians and use of antibiotics in the two group was calculated and expressed as a percentage. The χ² test was used to compare the percentages between the two groups. For all tests, P-values <0.05 were considered significant.
Since Italian National Health System covers all costs for pediatrician visits and antibiotics, cost assessment was made analysing the costs regarding the frequency of each parameters in treated and nontreated group. We considered as direct cost National Health System: Medical examination (20,66 euros for each examination, as provided by the Italian Ministry of Health) and use of Antibiotics (the cost was as in the list of the National Drug Authority).
研究の種類
入学 (実際)
段階
- フェーズ 4
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
Inclusion Criteria:
- 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
Exclusion Criteria:
- patients with findings suggestive of an immunodeficiency on history and physical examination
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：防止
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：独身
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
介入なし：コントロール
|
|
|
アクティブコンパレータ：Vit D
Vitamin D oral supplementation (400 UI/die up to 12 month or 600 UI/die beyond 1 year) from October to March
|
from October to March, a Vitamin D oral supplementation (400 UI/die up to 12 month or 600 UI/die beyond 1 year
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Number of recurrent respiratory tract infections for each months of study
時間枠：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
|
From October 1, 2014, and March 31, 2015, up to 6 months
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Cost assessment in euros according to antibiotics, paediatric visits and vitamin D supplementation
時間枠：From October 1, 2014, and March 31, 2015, up to 6 months
|
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.
|
From October 1, 2014, and March 31, 2015, up to 6 months
|
協力者と研究者
スポンサー
捜査官
- 主任研究者：Maria Elisabetta Baldassarre, MD、University of Bari
出版物と役立つリンク
一般刊行物
- de Sa Del Fiol F, Barberato-Filho S, Lopes LC, de Cassia Bergamaschi C. Vitamin D and respiratory infections. J Infect Dev Ctries. 2015 Apr 15;9(4):355-61. doi: 10.3855/jidc.5711.
- Zittermann A, Gummert JF. Nonclassical vitamin D action. Nutrients. 2010 Apr;2(4):408-25. doi: 10.3390/nu2040408. Epub 2010 Mar 25.
研究記録日
主要日程の研究
研究開始
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
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