CLINICAL TRIAL: A NOVEL DIAGNOSTIC TEST TO DETECT VITAMIN B12 DEFICIENCY

临床试验：检测维生素 B12 缺乏症的新型诊断测试

• 批准号: 7717129
• 负责人: Phillip TOSKES
• 金额: $ 4.93万
• 依托单位: UNIVERSITY OF FLORIDA
• 依托单位国家: 美国
• 财政年份: 2007
• 资助国家: 美国
• 起止时间: 2007-12-01 至 2008-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7717129
• 关键词: Affect; Aging; Alzheimer' s Disease; Atrophic Gastritis; Breath Tests; Clinical Trials; Collection; Computer Retrieval of Information on Scientific Projects Database; Dementia; Diagnosis; Diagnostic tests; Dose; Elderly; Fasting; Funding; Goals; Grant; Hour; Individual; Institution; Invasive; Label; Life; Malabsorption Syndromes; Malignant Neoplasms; Metabolism; Physicians; Population; Procedures; Propionates; Radioactive; Reference Values; Research; Research Personnel; Resources; Risk; Source; Specificity; Staging; Supplementation; Testing; Tracer; United States National Institutes of Health; Vitamin B 12; Vitamin B 12 Deficiency; novel diagnostics; pre-clinical

This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. Vitamin B-12 deficiency is a common problem that affects the general US population and the elderly in particular. The elderly are at risk for preclinical vitamin B-12 deficiency due to the increased presence of B-12 malabsorption and atrophic gastritis as a consequence of aging. The deficiency of vitamin B-12 in the elderly has potentially serious complications including dementia, Alzheimer?s disease, and cancer. Current approaches to diagnosing B-12 deficiency are inadequate because they lack specificity, have poorly defined reference ranges or are expensive. Our proposed test, known as the B-12 Breath Test will have the advantage of being non-invasive, be easy to administer and have a long shelf life. The BBT will allow physicians to accurately test for B-12 deficiency. Our goal is to identify vitamin B-12 deficiency in a preclinical stage when treatment can avert complications. Diagnosing this deficiency is meaningful because once identified as a problem, it can be effectively and inexpensively treated with appropriate vitamin B-12 supplementation. The underlying scientific principle of the test is that the metabolism of propionate is limited by the availability of vitamin B-12. Thus, after orally administering a tracer dose of 13C;non-radioactive; labeled propionate, the amount of 13CO2 is reduced in the breath of vitamin B-12 deficient individuals compared to those individuals with normal B-12 status. We will refine the testing procedure and simplify the test. We will examine a smaller dose of propionate, a single 20-minute breath collection and eliminate the fasted state for greater than 1 hour.

该副本是利用众多研究子项目之一 由NIH/NCRR资助的中心赠款提供的资源。子弹和 调查员（PI）可能已经从其他NIH来源获得了主要资金， 因此可以在其他清晰的条目中代表。列出的机构是 对于中心，这不一定是调查员的机构。 维生素B-12缺乏症是一个常见的问题，尤其会影响美国普通人群。 由于衰老，老年人面临临床前维生素B-12缺乏症的风险。 老年人中维生素B-12的缺乏可能存在严重的并发症，包括痴呆症，阿尔茨海默氏病和癌症。 当前诊断B-12缺乏症的方法由于缺乏特异性，定义范围较差或昂贵而不足。 我们提议的测试（称为B-12呼吸测试）将具有无创的优势，它易于管理并且具有较长的保质期。 BBT将允许医生准确测试B-12缺乏症。 我们的目标是在临床前阶段鉴定维生素B-12缺乏症，当治疗可能避免并发症。 诊断这种缺陷是有意义的，因为一旦被确定为问题，就可以通过补充适当的维生素B-12进行有效且廉价地处理。 该测试的基本科学原理是，丙酸酯的代谢受到维生素B-12的可用性的限制。 因此，口服示踪剂剂量为13c；非放射性剂量；标记为丙酸酯，与患有正常B-12状态的个体相比，维生素B-12缺乏个体的呼吸中13CO2的量减少。 我们将完善测试过程并简化测试。 我们将检查一个较小的丙酸剂量，一个20分钟的呼吸收集，并消除禁食状态超过1小时。