Colorectal Chemoprevention with Calcium and Vitamin D

使用钙和维生素 D 进行结直肠化学预防

• 批准号: 7811042
• 负责人: John Anthony Baron
• 金额: $ 33.66万
• 依托单位: DARTMOUTH COLLEGE
• 依托单位国家: 美国
• 财政年份: 2009
• 资助国家: 美国
• 起止时间: 2009-09-30 至 2010-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7811042
• 关键词: Acute; Address; Adopted; Affect; Calcium; Chemoprevention; Cholecalciferol; Clinical Research; Clinical Trials; Colorectal; Colorectal Adenoma; Communicable Diseases; Data; Economic Burden; Enrollment; Evaluable Disease; Event; Health; Immune system; Incidence; Infection; Influenza; Life Style; Medical; Monitor; Morbidity - disease rate; Online Systems; Paper; Parents; Play; Population; Prevention; Protocols documentation; Randomized; Randomized Controlled Clinical Trials; Recruitment Activity; Research; Respiratory System; Respiratory tract structure; Risk; Role; Seasons; Supplementation; Symptoms; United States; Upper Respiratory Infections; Vitamin D; diaries; double-blind placebo controlled trial; efficacy testing; gastrointestinal; gastrointestinal infection; gastrointestinal symptom; health economics; immune function; mortality; public health relevance; respiratory

DESCRIPTION (provided by applicant): Upper respiratory tract infection (URTI), influenza like illness (ILI) and acute gastrointestinal infection (AGI) are common in the U.S. and are associated with significant morbidity and economic burden. Accumulating evidence indicates that vitamin D may play an important role in immune function; epidemiologic and clinical studies have documented an association between lower vitamin D levels and increased risk of several infectious diseases, particularly those of the respiratory tract. We propose to evaluate the effect of supplementation with vitamin D on the incidence and duration of common respiratory and gastrointestinal infections by adding appropriate symptom surveillance to our ongoing randomized, placebo-controlled double blind trial testing the efficacy of supplementation with vitamin D (1000Iu daily) or calcium (1200 mg daily) for the prevention of colorectal adenomas. The trial has completed recruitment, and will have over 1000 subjects still on study treatment and potentially evaluable for symptom surveillance over at least one winter season. Subjects have complied well with the study protocol, and the trial has extensive data already collected regarding lifestyle, 25-(OH) vitamin D levels, and major medical events. In the research proposed here, subjects from the parent trial will be recruited to complete monthly symptom diaries regarding URTI, ILI and AGI. The diaries, either in paper form or web- based, will be will be completed daily and returned monthly to the Study Coordinating Center. Subjects will be instructed to record respiratory and gastrointestinal symptoms for up to 12 months. Using pre-defined definitions of URTI, ILI and AGI, we will adopt as endpoints the number of episodes of each type of illness and the total number of days of affected by the illness. Primary analyses will focus on URTI; exploratory analyses will address ILI and AGI. We project that will be able to recruit at least 812 subjects into this effort, more than half of whom will be monitored for a full year. We estimate we will have greater than 80% power to detect a reduction of 20% or more in the incidence of URTI and even greater power to assess effects on number of days affected by these infections. PUBLIC HEALTH RELEVANCE: Colds, influenza and acute gastrointestinal infections are common occurrences in the United States, and are associated with a significant health and economic burden. Accumulating evidence indicates that vitamin D is important for immune functioning and that higher vitamin D levels may protect against these illnesses. In the study proposed here, we will evaluate the ability of supplemental vitamin D to reduce the risk of developing those infectious disorders.

描述（由申请人提供）：上呼吸道感染（URTI）、流感样疾病（ILI）和急性胃肠道感染（AGI）在美国很常见，并且与显着的发病率和经济负担相关。越来越多的证据表明维生素 D 可能在免疫功能中发挥重要作用；流行病学和临床研究已证明维生素 D 水平较低与多种传染病（尤其是呼吸道传染病）风险增加之间存在关联。我们建议通过在我们正在进行的随机、安慰剂对照双盲试验中添加适当的症状监测来评估补充维生素 D 对常见呼吸道和胃肠道感染的发病率和持续时间的影响，该试验测试补充维生素 D 的功效（每天 1000Iu）或钙（每天 1200 毫克）以预防结直肠腺瘤。该试验已完成招募，将有 1000 多名受试者仍在接受研究治疗，并且可能在至少一个冬季进行症状监测评估。受试者很好地遵守了研究方案，并且该试验已经收集了有关生活方式、25-(OH) 维生素 D 水平和重大医疗事件的大量数据。在此提出的研究中，将招募来自母体试验的受试者来完成有关 URTI、ILI 和 AGI 的每月症状日记。日记，无论是纸质的还是网络的，将每天完成并每月返回给研究协调中心。受试者将被指示记录呼吸道和胃肠道症状长达 12 个月。使用 URTI、ILI 和 AGI 的预定义定义，我们将采用每种疾病的发作次数和受疾病影响的总天数作为终点。初步分析将集中于 URTI；探索性分析将涉及 ILI 和 AGI。我们预计将能够招募至少 812 名受试者参与这项工作，其中一半以上将接受全年监测。我们估计，我们将有超过 80% 的能力检测到 URTI 发病率降低 20% 或更多，甚至更有能力评估对受这些感染影响的天数的影响。公共卫生相关性：感冒、流感和急性胃肠道感染在美国很常见，并带来重大的健康和经济负担。越来越多的证据表明，维生素 D 对免疫功能很重要，较高的维生素 D 水平可以预防这些疾病。在此提出的研究中，我们将评估补充维生素 D 降低患这些传染病风险的能力。