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Randomized Trial: Maternal Vitamin D Supplementation to Prevent Childhood Asthma

随机试验：母亲补充维生素 D 可预防儿童哮喘

基本信息

批准号：
8541924
负责人：
AUGUSTO A LITONJUA
金额：
$ 5.47万
依托单位：
BRIGHAM AND WOMEN'S HOSPITAL
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/8541924
关键词：
3 year old Address Affect Age Allergic Area Asthma Autoimmune Diseases Awareness Behavioral Birth Blood Cells Child Childhood Childhood Asthma Chronic Disease Cities Clinic Clinical Clinical Trials Cohort Studies Consensus Control Groups Data Developing Countries Diagnosis Diet Dietary Supplementation Dietary intake Discipline of obstetrics Disease Dose Double-Blind Method Eczema Environmental Risk Factor Epidemic Exposure to Fatty acid glycerol esters First Pregnancy Trimester Health Benefit Health Care Costs Healthcare Hormones Hypersensitivity IgE Immune System Diseases Immune response Immune system Incidence Inflammation Inflammatory Bowel Diseases Insulin-Dependent Diabetes Mellitus Intake Interleukin-10 Intervention Lead Life Lower Respiratory Tract Infection Lung Maintenance Measurement Morbidity - disease rate Mothers Multi-Institutional Clinical Trial Multiple Sclerosis National Heart, Lung, and Blood Institute Nutrient Placebo Control Placebos Plasma Population Pregnancy Pregnant Women Prevalence Prevention Production Public Health Randomized Randomized Clinical Trials Randomized Controlled Clinical Trials Recruitment Activity Recurrence Regulation Respiratory Tract Infections Rheumatoid Arthritis Risk Rural Seasonal Variations Second Pregnancy Trimester Skin Cancer Spontaneous abortion Sun Exposure Sunlight Supplementation Systems Development TGFB1 gene The Sun Time Umbilical Cord Blood Variant Vitamin D Vitamin D Deficiency Vitamins Wheezing Withdrawal arm asthma prevention burden of illness disorder prevention disorder risk follow-up improved in utero innovation interest neonate novel strategies offspring pregnant prenatal prevent primary outcome public health relevance randomized trial secondary outcome stillbirth

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）：