Randomized Controlled Trial: VDAART Continuation Study - CCC

随机对照试验：VDAART 继续研究 - CCC

基本信息

批准号：
8849478
负责人：
Robert Strunk
金额：
$ 43.71万
依托单位：
WASHINGTON UNIVERSITY
依托单位国家：
美国
项目类别：
财政年份：
2007
资助国家：
美国
起止时间：
2007-12-01 至 2019-04-30
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/8849478
关键词：
3 year old 6 year old Accounting Address Age Allergic Allergic rhinitis Animal Model Area Asthma Biological Markers Birth Child Child health care Childhood Childhood Asthma Cholecalciferol Chronic Disease Clinical Clinical Trials Development Diagnosis Disease Double-Blind Method Eczema Enrollment Epidemiologic Studies Fetal Lung Food Food Hypersensitivity Frequencies Genomics Gestational Age Goals Growth Health Health Care Costs Hormones Hypersensitivity IgE Immune system Incidence Intake Intention Interruption Investigation Knowledge Lead Life Live Birth Lower Respiratory Tract Infection Lung Measurement Measures Morbidity - disease rate Mothers Observational Study Oscillometry Outcome Performance Phenotype Placebos Play Pregnancy Pregnant Women Prevalence Public Health Questionnaires Randomized Randomized Clinical Trials Randomized Controlled Trials Recruitment Activity Recurrence Research Research Design Respiratory Tract Infections Respiratory physiology Risk Role Series Specimen Spirometry Supplementation Symptoms Telephone Testing Time Tissues Visit Vitamin D Vitamin D Deficiency Vitamin D3 Receptor Vitamins Wheezing Woman acronyms arm asthma prevention bone cohort disorder prevention early childhood epigenomics follow-up in utero lung development microbiome novel offspring pregnant prenatal prevent randomized placebo controlled trial randomized trial research study secondary outcome

3 year old 6 year old Accounting Address Age Allergic Allergic rhinitis Animal Model Area Asthma Biological Markers Birth Child Child health care Childhood Childhood Asthma Cholecalciferol Chronic Disease Clinical Clinical Trials Development Diagnosis Disease Double-Blind Method Eczema Enrollment Epidemiologic Studies Fetal Lung Food Food Hypersensitivity Frequencies Genomics Gestational Age Goals Growth Health Health Care Costs Hormones Hypersensitivity IgE Immune system Incidence Intake Intention Interruption Investigation Knowledge Lead Life Live Birth Lower Respiratory Tract Infection Lung Measurement Measures Morbidity - disease rate Mothers Observational Study Oscillometry Outcome Performance Phenotype Placebos Play Pregnancy Pregnant Women Prevalence Public Health Questionnaires Randomized Randomized Clinical Trials Randomized Controlled Trials Recruitment Activity Recurrence Research Research Design Respiratory Tract Infections Respiratory physiology Risk Role Series Specimen Spirometry Supplementation Symptoms Telephone Testing Time Tissues Visit Vitamin D Vitamin D Deficiency Vitamin D3 Receptor Vitamins Wheezing Woman acronyms arm asthma prevention bone cohort disorder prevention early childhood epigenomics follow-up in utero lung development microbiome novel offspring pregnant prenatal prevent randomized placebo controlled trial randomized trial research study secondary outcome

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项目摘要

DESCRIPTION (provided by applicant): Asthma is one of the leading causes of morbidity in children with the majority of all cases diagnosed in early childhood and over 56 billion dollars in health costs annually. Thus, finding factors that can lead to prevention of this disease would be of great public health importance. Vitamin D deficiency is highly prevalent among pregnant women, and thus, represents a potentially modifiable factor for the prevention of disease. Due to the effect of vitamin D in the development of the lung and the immune system in utero, we believe that vitamin D deficiency in pregnant mothers leads to increased risks for developing asthma and allergy in early childhood. Epidemiologic studies that have investigated the role of vitamin D in early life and the development of asthma, wheeze and allergy have inconsistent results. Because of the wide prevalence of vitamin D deficiency, a clinical trial is the only way t confidently answer the question of whether higher vitamin D levels in pregnancy can prevent asthma and allergies in the mother's offspring. Over the past 4 years, we have been conducting a randomized, placebo-controlled trial of maternal vitamin D supplementation in pregnancy, and we are now following the children (ClinicalTrials.gov Identifier: NCT00920621). We recruited 881 women, and randomized them to one of two arms: 4,000 IU vitamin D3 daily plus a prenatal vitamin containing 400 IU vitamin D3 vs. a placebo plus a prenatal vitamin containing 400 IU vitamin D3. We followed them through pregnancy and there were 810 live births with 801 currently under follow-up. The goal of the current project is to follow the children through age 6 years. The specific aims for the renewal of VDAART are: (1) to determine whether maternal supplementation of vitamin D during pregnancy is associated with reduced incidence of asthma in the child during the first 6 years of life; (2) to determine whether maternal supplementation of vitamin D during pregnancy is associated with reduced secondary outcomes in the child of: (a) allergic sensitization (total and specific IgE), (b) doctor's diagnosis of eczema, (c) doctor's diagnosis of allergic rhinitis, (d) food allergies and (e) lower respiratory tract infections by ag 6 years; (3) to determine whether maternal supplementation of vitamin D during pregnancy is associated with greater lung growth in the children up to age 6, as measured by impulse oscillometry and spirometry; and (4) to continue to collect biologic material from the children for mechanistic studies related to vitamin D in asthma and allergies, including specimens for genomic and epigenomic studies and microbiome studies. Findings from this important study will have great public health importance in the prevention of asthma and allergies in childhood.

描述（由申请人提供）：哮喘是儿童发病率的主要原因之一，大多数童年诊断出的病例中的大多数，超过560亿美元健康费用每年。因此，寻找可以预防这种疾病的因素将具有极大的公共健康重要性。维生素D缺乏症在孕妇中非常普遍，因此代表了预防疾病的潜在可修改因素。由于维生素D在肺部发育和子宫内免疫系统中的影响，我们认为怀孕母亲的维生素D缺乏会导致增加童年时期哮喘和过敏的风险。研究了维生素D在早期生活以及哮喘，喘息和过敏的发展的流行病学研究效果不一致。由于维生素D缺乏症的普遍存在，临床试验是T唯一的唯一方法，即唯一的方法可以回答以下问题：妊娠中较高的维生素D水平是否可以预防母亲后代中的哮喘和过敏。在过去的四年中，我们一直在妊娠中补充母体维生素D的随机，安慰剂对照试验，现在我们正在追随儿童（ClinicalTrials.govs.gov标识符：NCT00920621）。我们招募了881名女性，并将其随机分为两个臂之一：每天4,000 IU维生素D3以及含有400 IU维生素D3的产前维生素与安慰剂加上含400 IU维生素D3的产前维生素。我们跟随他们怀孕，目前有810例活产，目前有801例。当前项目的目标是跟随儿童到6岁。续签VDAART的具体目的是：（1）确定孕妇在怀孕期间对维生素D的补充是否与儿童哮喘发病率降低有关；（2）确定是否补充母亲怀孕期间的维生素D与儿童的继发性降低有关：（a）过敏性敏化（总和特定的IgE），（b）医生诊断出湿疹的诊断，（c）医生诊断出过敏性鼻炎，（d）食物过敏和（e）下呼吸道的下呼吸道感染。（3）确定怀孕期间的母体补充维生素D是否与6岁以下儿童的肺部生长更大有关，如脉冲振荡和肺活量测定法测量；（4）继续从孩子那里收集生物学材料机械研究与哮喘和过敏中的维生素D有关，包括用于基因组和表观基因组研究和微生物组研究的标本。这项重要研究的发现将在预防童年时期的哮喘和过敏方面具有极大的公共健康重要性。