Vitamin D to Prevent Severe Asthma Exacerbations in High-Risk Children: DCC

维生素 D 可预防高危儿童哮喘严重发作：DCC

基本信息

批准号：
9283260
负责人：
Stephen R Wisniewski
金额：
$ 37.06万
依托单位：
UNIVERSITY OF PITTSBURGH AT PITTSBURGH
依托单位国家：
美国
项目类别：
财政年份：
2015
资助国家：
美国
起止时间：
2015-06-17 至 2020-05-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/9283260
关键词：
Adjuvant Therapy Adrenal Cortex Hormones Advocate Affect Asthma Breathing Child Childhood Cholecalciferol Clinical Clinical Trials Communication Controlled Clinical Trials Data Data Coordinating Center Direct Costs Dose Emergency department visit Epidemiology Goals Hospitalization Immune Incidence Institute of Medicine (U.S.)Intake Lead Link Masks Methods Musculoskeletal Nutrient Observational Study Placebo Control Placebos Predisposition Pregnancy Procedures Public Health Quality Control Randomized Reporting Research Risk School-Age Population Serum Severity of illness Supplementation System Testing Viral Virus Diseases Vitamin D Vitamin D Deficiency Vitamin D supplementation Work aged clinical practice cost data management design experimental study high risk immunoregulation prevent protective effect public health relevance respiratory health response

项目摘要

DESCRIPTION (provided by applicant): Findings from observational studies by our group and others suggest that vitamin D insufficiency (a common condition) is associated with an increased risk of severe asthma exacerbations in school-aged children. We hypothesize that vitamin D supplementation reduces the incidence of severe asthma exacerbations in high-risk (so defined due to an exacerbation in the previous year) children aged 6 to 14 years who have vitamin D insufficiency (a serum 25(OH) D <30 ng/ml) and who are being treated with inhaled corticosteroids (ICS) for mild to moderate persistent asthma. We further hypothesize that this protective effect results from a reduced incidence of viral infections that lead to severe asthma exacerbations and/or enhanced response to ICS in these children. We will test this hypothesis in a randomized double-masked placebo-controlled clinical trial with the following primary and secondary Specific Aims: Primary Specific Aim 1) To determine whether vitamin D3 supplementation (4,000 IU/day) is superior to placebo in preventing severe asthma exacerbations in high-risk school-aged children who have vitamin D insufficiency and who are on ICS for mild to moderate persistent asthma. Secondary Specific Aims In high-risk school-aged children with vitamin D insufficiency who are on ICS for asthma, to determine whether vitamin D3 supplementation is superior to placebo in: 1) Preventing severe asthma exacerbations resulting from viral infections 2) Reducing the daily dose of ICS as well as the average cumulative dose of ICS, at the end of the trial.

描述（由申请人提供）：我们小组和其他人的观察研究结果表明，维生素 D 不足（一种常见病症）与学龄儿童严重哮喘发作的风险增加有关。我们认为补充维生素 D 可以降低哮喘严重发作的风险。 6 至 14 岁维生素 D 不足（血清25（OH）D <30 ng/ml）以及正在接受吸入皮质类固醇（ICS）治疗轻度至中度持续性哮喘的患者我们进一步发现，这种保护作用是由于导致严重哮喘发作的病毒感染发生率降低所致。我们将在一项随机双盲安慰剂对照临床试验中检验这一假设，其主要和次要具体目标如下：主要具体目标 1) 确定是否补充维生素 D3。（4,000 IU/天）在预防维生素 D 不足且因轻度至中度持续性哮喘而服用 ICS 的高危学龄儿童中，优于安慰剂。因哮喘而服用 ICS 的维生素 D 不足儿童，以确定维生素 D3 补充剂在以下方面是否优于安慰剂：1) 预防病毒感染导致的严重哮喘恶化 2) 减少试验结束时 ICS 的每日剂量以及 ICS 的平均累积剂量。