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RANDOMIZED TRIAL: MATERNAL VITAMIN D SUPPLEMENTATION TO PREVENT CHILDHOOD ASTHMA

随机试验：母体维生素 D 补充剂预防儿童哮喘

基本信息

批准号：
8233351
负责人：
Robert Strunk
金额：
$ 42.48万
依托单位：
WASHINGTON UNIVERSITY
依托单位国家：
美国
项目类别：
财政年份：
2009
资助国家：
美国
起止时间：
2009-03-01 至 2014-02-28
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/8233351
关键词：
Age Allergic Asthma Behavioral Birth Blood Child Childhood Asthma Clinic Clinical Clinical Trials Cohort Studies Companions Data Data Coordinating Center Diagnosis Dietary Supplementation Discipline of obstetrics Disease Dose Double-Blind Method Eczema Epidemic First Pregnancy Trimester Grant Health Benefit Health Care Costs Hypersensitivity Immune response Immune system Incidence Intake Intervention Lead Life Link Lower Respiratory Tract Infection Measurement Morbidity - disease rate Mothers Placebo Control Plasma Pregnancy Pregnant Women Prevalence Prevention Production Public Health Randomized Randomized Clinical Trials Randomized Controlled Clinical Trials Recruitment Activity Recurrence Risk Sun Exposure Supplementation Systems Development The Sun Time Umbilical Cord Blood Vitamin D Vitamin D Deficiency Vitamins Wheezing arm disorder prevention improved innovation neonate novel strategies offspring pregnant prenatal prevent public health relevance randomized trial secondary outcome

项目摘要

DESCRIPTION (provided by applicant): Asthma is one of the leading causes of morbidity in children with 60% of all cases diagnosed by age 3. 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 modulating immune responses, we believe that vitamin D deficiency in pregnant mothers leads to faulty immune system development in the neonate, predisposing them to asthma and allergy. We have observational data from two independent birth cohort studies that higher maternal intakes of vitamin D during pregnancy are each independently associated with a 50% reduction in risk for recurrent wheezing and asthma in 3- and 5-yr old children. However, in order to recommend this as a universal treatment to prevent asthma, a randomized, controlled, clinical trial is necessary. Therefore, we propose a two arm, double-blind, placebo controlled, randomized, clinical trial of Vitamin D, to determine whether higher vitamin D intake and levels in the pregnant mother will prevent asthma and allergy in the child at age 3. We will identify pregnant women who have asthma or allergies or whose partner has asthma or allergies, from obstetric clinics in the three clinical centers participating in this trial. We will recruit 870 pregnant women during the first trimester of pregnancy and randomize them to one of two treatment arms of a 4-year clinical trial: 4000 IU of Vitamin D in addition to usual prenatal vitamins, n=435; and usual prenatal vitamins alone, n=435. Our primary specific aim is to determine whether adequate vitamin D supplementation in the pregnant mother is associated with reduced incidence of asthma in the child during the first 3 years of life. The sub-aims of the study will include (1) To determine whether adequate vitamin D supplementation in the pregnant mother is associated with reduced secondary outcomes in the child of (a) allergic sensitization, (b) doctor's diagnosis of eczema and (c) lower respiratory tract infections during the first 3 years of life; and (2) To determine whether adequate vitamin D supplementation in the pregnant mother is associated with improved vitamin D status in the mothers and their offspring through measurement of 25(OH)D levels in maternal plasma, cord blood, and children's blood at 1 and 3 yrs of age. Public Health Relevance: We believe that it is likely that Vitamin D deficiency has had a significant impact on the asthma epidemic that began in the early 1980's. Greater time spent indoors, and use of sun screen has resulted in reduced sun exposure and decreased production of vitamin D; and lack of adequate dietary supplementation to compensate for these behavioral changes, results in very low vitamin D levels. We believe that with adequate dosing of vitamin D in pregnant women, we can prevent half of all asthma cases in their offspring and ultimately reduce disease prevalence to pre-1980 levels. If successful, this trial will ultimately decrease asthma incidence by 50% and consequently decrease health care costs by 8 billion dollars. This intervention is cheap, safe, and will result in major public health benefit. It also represents the most innovative and novel approach to asthma treatment and prevention in the last 30 years.

描述（由申请人提供）：