A Novel Diagnostic Test to Detect Vitamin B12 Deficiency

检测维生素 B12 缺乏症的新型诊断测试

• 批准号: 7163170
• 负责人: DAVID A WAGNER
• 金额: $ 36.07万
• 依托单位: METABOLIC SOLUTIONS, INC.
• 依托单位国家: 美国
• 财政年份: 2003
• 资助国家: 美国
• 起止时间: 2003-04-01 至 2008-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7163170
• 关键词: breath tests; carbon dioxide; clinical research; cost effectiveness; diagnosis design /evaluation; dosage; early diagnosis; fatty acid metabolism; gastrointestinal disorder diagnosis; human old age (65+); human subject; malonates; nutrition disorder diagnosis; nutrition related tag; propionates; vitamin B12; vitamin deficiency

DESCRIPTION (provided by applicant): Vitamin B12 deficiency is a common problem that affects the general US population and the elderly in particular. The elderly are at risk for preclinical vitamin B12 deficiency due to the increased presence of B12 malabsorption and atrophic gastritis as a consequence of aging. The deficiency of vitamin B12 in the elderly has potentially serious complications including dementia, Alzheimer's disease, and cancer. Current approaches to diagnosing B12 deficiency are inadequate because they lack specificity, have poorly defined reference ranges or are expensive. Our proposed test, known as the B12 Breath Test (BBT), 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 B12 deficiency at a much lower cost than current diagnostic tests. Our goal is to identify vitamin B12 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 B12 supplementation. This will lead to lower overall medical costs as this condition is quickly identified and appropriately treated. The underlying scientific principle of the test is that the metabolism of propionate is limited by the availability of vitamin B12. Thus, after orally administering a tracer dose of 13 C (non-radioactive) labeled propionate, the amount of 13 CO2 is reduced in the breath of vitamin B12 deficient individuals compared to those individuals with normal B12 status. The phase I grant demonstrated the feasibility of this concept. In Phase II we will refine the testing procedure with the goal to reduce test costs and simplify the test. Specifically, we will examine a smaller dose of propionate, a single 20-minute breath collection and eliminate the need to be in a fasted state for greater than 1 hour. The final product developed after Phase III will be an FDA approved diagnostic kit. This kit will be sold to our current clinical laboratory customers, to other independent clinical labs and to the more than 1,000 physician laboratories that have point-of-care breath testing equipment. Project Narrative: Vitamin B12 deficiency is a common problem found in the elderly that is difficult to identify early because there isn't an accurate and low cost diagnostic test. The deficiency of vitamin B12 has potentially serious complications including dementia, Alzheimer's disease, and cancer. The proposed test will address this diagnostic need and lead to better quality of life for these patients because vitamin B12 deficiency can be easily and inexpensively treated with vitamin supplements.

描述（由申请人提供）：维生素 B12 缺乏是影响美国普通民众，尤其是老年人的一个常见问题。由于衰老导致维生素 B12 吸收不良和萎缩性胃炎的增加，老年人面临临床前维生素 B12 缺乏的风险。老年人缺乏维生素 B12 可能会导致严重的并发症，包括痴呆、阿尔茨海默病和癌症。目前诊断 B12 缺乏症的方法还不够充分，因为它们缺乏特异性、参考范围定义不明确或者价格昂贵。我们提出的测试称为 B12 呼气测试 (BBT)，具有非侵入性、易于管理且保质期长的优点。 BBT 将使医生能够以比当前诊断测试低得多的成本准确测试 B12 缺乏症。我们的目标是在临床前阶段发现维生素 B12 缺乏症，此时治疗可以避免并发症。诊断这种缺乏症很有意义，因为一旦确定为问题，就可以通过补充适当的维生素 B12 来有效且廉价地治疗。由于这种情况能够被快速识别并得到适当治疗，这将导致总体医疗成本降低。该测试的基本科学原理是丙酸盐的代谢受到维生素 B12 可用性的限制。因此，口服 13 C（非放射性）标记丙酸盐示踪剂量后，与维生素 B12 状态正常的个体相比，缺乏维生素 B12 的个体呼吸中 13 CO2 的量减少。第一阶段的资助证明了这一概念的可行性。在第二阶段，我们将完善测试程序，目标是降低测试成本并简化测试。具体来说，我们将检查较小剂量的丙酸盐、单次 20 分钟的呼吸收集，并消除禁食状态超过 1 小时的需要。第三阶段之后开发的最终产品将是 FDA 批准的诊断试剂盒。该套件将出售给我们当前的临床实验室客户、其他独立临床实验室以及拥有床边呼气测试设备的 1,000 多个医师实验室。 项目叙述：维生素 B12 缺乏症是老年人中常见的问题，由于没有准确且低成本的诊断测试，因此很难及早发现。维生素 B12 缺乏可能会导致严重的并发症，包括痴呆、阿尔茨海默病和癌症。拟议的测试将满足这一诊断需求，并为这些患者带来更好的生活质量，因为维生素 B12 缺乏症可以通过维生素补充剂轻松且廉价地治疗。