Somnath Sanjana H, Biswal Niranjan, Chandrasekaran Venkatesh, Jagadisan Barath, Bobby Zachhariah
Department of Pediatrics, Jawaharlal Institute of Postgraduate Medical Education and Research (JIPMER), Dhanvantari Nagar, Pondicherry 605006, India.
Department of Pediatrics, Jawaharlal Institute of Postgraduate Medical Education and Research (JIPMER), Dhanvantari Nagar, Pondicherry 605006, India.
Clin Nutr ESPEN. 2017 Aug;20:24-28. doi: 10.1016/j.clnesp.2017.02.003. Epub 2017 May 3.
To study the effect of vitamin D supplementation on the outcome of acute lower respiratory infection in hospitalized children.
This is an open label parallel group randomized trial. Total of 154 children aged 2 mo-5 yrs (mean age 13 mo) admitted with acute lower respiratory infection (ALRI) were randomized to receive standard care therapy alone or standard care therapy for the respiratory infection along with a single oral dose of 100,000 IU of vitamin D3. Serum 25(OH)D levels were measured at admission in all the children and 72 h after administration of vitamin D in the supplemented group. Primary outcome measured was the duration of hospital stay. Secondary outcomes measured were mortality, incidence of complications, admission to PICU and recurrence of respiratory infections within 90 days of discharge. Primary outcome was compared using Mann Whitney U test and secondary outcomes were compared using chi-square or Fischer's exact test.
Baseline characteristics were comparable between the two groups. There was no statistically significant difference in the primary outcome (Median duration of hospital stay in both the groups) and also in secondary outcomes (mortality, PICU admission, complications and recurrence of respiratory infections within 90 days of discharge).
Single oral dose of 100,000 IU of vitamin D did not lead to reduction in duration of hospital stay, mortality, PICU admission or complications related to ALRI when compared to standard therapy alone in under five children hospitalized with ALRI but was able to achieve serum vitamin D sufficiency within 72 h of administration. Registered under clinical trial Registry of India Identifier no: CTRI/2014/09/005032.
研究补充维生素D对住院儿童急性下呼吸道感染结局的影响。
这是一项开放标签平行组随机试验。总共154名年龄在2个月至5岁（平均年龄13个月）的急性下呼吸道感染（ALRI）住院儿童被随机分为两组，一组仅接受标准护理治疗，另一组在接受呼吸道感染标准护理治疗的同时口服单剂量100,000国际单位的维生素D3。所有儿童在入院时以及补充组给予维生素D后72小时测量血清25(OH)D水平。主要结局指标为住院时间。次要结局指标为死亡率、并发症发生率、入住儿科重症监护病房（PICU）情况以及出院后90天内呼吸道感染复发情况。主要结局采用Mann-Whitney U检验进行比较，次要结局采用卡方检验或Fisher精确检验进行比较。
两组的基线特征具有可比性。主要结局（两组的住院时间中位数）以及次要结局（死亡率、入住PICU、并发症以及出院后90天内呼吸道感染复发）在统计学上均无显著差异。
与仅接受标准治疗的5岁以下ALRI住院儿童相比，单次口服100,000国际单位的维生素D并不能缩短住院时间、降低死亡率、减少入住PICU或降低与ALRI相关的并发症，但能够在给药后72小时内使血清维生素D达到充足水平。在印度临床试验注册中心注册，标识符：CTRI/2014/09/005032。
