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（由适用提供）：我们小组的观察性研究结果和其他研究结果表明，维生素D不足（一种常见状况）与校际儿童严重哮喘患病的风险增加有关。我们假设补充维生素D会降低高危哮喘加重的发生率（由于上一年在上一年的加重而定义）6至14岁的儿童患有维生素D不足（A Serum 25（A OH）D <30 ng/ml），并与CortiCosterics corniCSICSICSSICSSICSSICSSICSSICSSICSSICSSICSSICSSICSSICSSICSSICSSICSSICSSICSSICSSSICSSICSSICSSICSSICSSICSSICSSICSSICSSICSSICSRATY（OH）D <30 ng/ml（OH）。我们将进一步假设，这种保护作用是由于病毒感染的发生率降低，导致严重的哮喘患者和/或这些儿童对IC的反应增强。我们将在随机的双层安慰剂对照临床试验中检验这一假设，其主要和次要特定目的：主要特定目的1）确定补充维生素D3（4,000 IU/天）是否优于安慰剂，在预防高风险的学校中具有维生素deptribal defult defulds dermants and Induffects ans Insications的高风险哮喘患者中的严重哮喘患者在严重的哮喘中是否优于安慰剂。哮喘ICS的维生素D不足的高风险学龄儿童的次要特定目标，以确定维生素D3补充剂是否优于安慰剂：1）防止因病毒感染而导致严重的哮喘加剧2）减少IC的日常剂量，以减少IC的日常累积剂量以及IC的平均累积剂量。