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

• 批准号: 8433327
• 负责人: Robert Strunk
• 金额: $ 40.9万
• 依托单位: WASHINGTON UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2009
• 资助国家: 美国
• 起止时间: 2009-03-01 至 2014-05-14
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8433327
• 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

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.

描述（由申请人提供）： 哮喘是儿童发病的主要原因之一，其中 60% 的病例是在 3 岁之前诊断出来的。因此，找到能够预防这种疾病的因素对于公共卫生具有重要意义。维生素 D 缺乏症在孕妇中非常普遍，因此，维生素 D 缺乏症是预防疾病的一个潜在可改变因素。由于维生素 D 具有调节免疫反应的作用，我们认为孕妇缺乏维生素 D 会导致新生儿免疫系统发育缺陷，使他们容易患哮喘和过敏。我们从两项独立出生队列研究中获得的观察数据表明，母亲在怀孕期间摄入较高的维生素 D 与 3 岁和 5 岁儿童反复喘息和哮喘的风险降低 50% 独立相关。然而，为了推荐将此作为预防哮喘的普遍治疗方法，需要进行随机、对照的临床试验。因此，我们建议开展一项维生素 D 的双臂、双盲、安慰剂对照、随机临床试验，以确定孕妇较高的维生素 D 摄入量和水平是否会预防 3 岁时孩子的哮喘和过敏。我们将从参与该试验的三个临床中心的产科诊所中识别患有哮喘或过敏的孕妇或其伴侣患有哮喘或过敏的孕妇。我们将招募 870 名怀孕前三个月的孕妇，并将她们随机分配到为期 4 年的临床试验的两个治疗组之一：除了常规的产前维生素外，还服用 4000 IU 维生素 D，n=435；和单独使用常规产前维生素，n=435。我们的主要具体目标是确定怀孕母亲补充足够的维生素 D 是否与降低孩子出生后 3 年内的哮喘发病率有关。该研究的子目标将包括 (1) 确定怀孕母亲补充足够的维生素 D 是否与孩子出生后 3 年内减少以下继发后果相关：(a) 过敏性过敏、(b) 医生诊断为湿疹和 (c) 下呼吸道感染； (2) 通过测量母体血浆、脐带血以及 1 岁和 3 岁儿童血液中的 25(OH)D 水平，确定怀孕母亲补充足够的维生素 D 是否与母亲及其后代维生素 D 状况的改善相关。