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），像疾病（ILI）和急性胃肠道感染（AGI）（AGI）在美国很常见，并且与大量发病率和经济负担有关。积累的证据表明，维生素D可能在免疫功能中起重要作用。流行病学和临床研究已经证明了较低的维生素D水平与几种传染病的风险增加之间的关联，尤其是呼吸道的风险。 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.该试验已完成招聘，并将在至少一个冬季中有1000多名受试者进行研究治疗，并有可能评估症状监测。受试者与研究方案非常吻合，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。在此处提出的研究中，将招募父母试验的受试者，以完成有关URTI，ILI和AGI的每月症状日记。这些日记（以纸质形式或基于网络形式）将每天完成，每月返回研究协调中心。受试者将被指示记录长达12个月的呼吸道和胃肠道症状。使用预定义的urti，ILI和AGI的定义，我们将采用每种疾病的发作数量和受疾病影响的天数的终点。主要分析将集中于URTI；探索性分析将解决ILI和AGI。我们预测将能够将至少812名受试者招募到这项工作中，其中一半以上将被监视整整一年。我们估计，我们将拥有超过80％的功率，以检测到URTI发生率的降低20％或更多，甚至更大的能力来评估对受这些感染影响的天数的影响。公共卫生相关性：在美国，感冒，流感和急性胃肠道感染是常见的情况，与健康和经济负担相关。积累的证据表明，维生素D对于免疫功能很重要，较高的维生素D水平可以预防这些疾病。在此处提出的研究中，我们将评估补充维生素D降低这种传染病的风险的能力。