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.

这个子项目是许多研究子项目中的一个 由NIH/NCRR资助的中心赠款提供的资源。子项目和 研究者（PI）可能从另一个NIH来源获得了主要资金， 因此可以在其他CRISP条目中表示。所列机构为 研究中心，而研究中心不一定是研究者所在的机构。 维生素B-12缺乏症是一个常见的问题，影响一般美国人口，特别是老年人。 老年人由于衰老导致B-12吸收不良和萎缩性胃炎的存在增加，因此处于临床前维生素B-12缺乏的风险中。 老年人缺乏维生素B-12有潜在的严重并发症，包括痴呆症，阿尔茨海默病？的疾病和癌症。 目前诊断B-12缺乏症的方法是不够的，因为它们缺乏特异性，参考范围定义不明确或昂贵。 我们提出的测试，被称为B-12呼吸测试将具有非侵入性的优势，易于管理，并具有较长的保质期。 BBT将允许医生准确地测试B-12缺乏症。 我们的目标是在临床前阶段确定维生素B-12缺乏症，此时治疗可以避免并发症。 诊断这种缺乏是有意义的，因为一旦确定为一个问题，它可以有效和廉价的治疗与适当的维生素B-12补充。 该测试的基本科学原理是丙酸盐的代谢受到维生素B-12的可用性的限制。 因此，在口服给予示踪剂量的13 C、非放射性、标记的丙酸盐后，与具有正常B-12状态的个体相比，维生素B-12缺乏个体的呼吸中13 CO2的量减少。 我们将改进测试程序并简化测试。 我们将检查较小剂量的丙酸盐，单次20分钟的呼吸收集，并消除超过1小时的禁食状态。