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: 6585594
• 负责人: DAVID A WAGNER
• 金额: $ 10.69万
• 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 2004-09-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6585594
• 关键词: biomarker; breath tests; carbon; carbon dioxide; clinical research; diagnosis design /evaluation; fatty acid metabolism; human subject; nutrition disorder diagnosis; propionates; radiotracer; stable isotope; vitamin B12; vitamin B12 deficiency

DESCRIPTION (provided by applicant): Vitamin B 12 deficiency is a common, but under diagnosed condition found primarily in the elderly. This deficiency mainly results from changes in the gastrointestinal tract that take place during aging and from certain medications. Untreated, this condition can lead to physical and mental impairment that significantly reduces the quality of life and increases health care expenditures. Current approaches to diagnose vitamin B 12 deficiency lack specificity, have poorly defined reference ranges and are expensive. Our objective is to fill the need for a low cost, accurate and simple test. Metabolic Solutions, Inc. (MSI) has developed a breath test based on the principle that the metabolism of propionate is limited by the availability of vitamin B12. Thus, after orally administering a tracer dose of 13C (non-radioactive) labeled propionate the amount of 13CO2 appears less intensely in the breath of vitamin B12 deficient individuals as compared to those individuals with normal B12 status. During phase I, we plan to demonstrate that the breath test distinguishes adequate from deficient vitamin B12 individuals and that the breath test changes with treatment. Early screening and prompt diagnosis of vitamin B12 deficiency will prevent devastating complications. A small window of opportunity exists to reverse neurological complications. Any delay in instituting treatment may result in little or no improvement in cognitive function. Providing physicians with an accurate, low cost tool for diagnosing vitamin B12 deficiency will not only improve patient care but is cost-effective because once identified this condition can be successfully and inexpensively treated.

描述(由申请人提供)：维生素B12缺乏症是一种常见的疾病，但在确诊情况下主要见于老年人。这种缺陷主要是由于衰老过程中胃肠道的变化和某些药物引起的。如果不进行治疗，这种情况可能会导致身体和精神损伤，从而显著降低生活质量并增加医疗保健支出。 目前诊断维生素B12缺乏症的方法缺乏特异性，参考范围界定不明确，而且价格昂贵。我们的目标是满足对低成本、准确和简单测试的需求。代谢解决方案公司(MSI)开发了一种呼气测试，其原理是丙酸的新陈代谢受到维生素B12供应的限制。因此，口服示踪剂13C(非放射性)标记的丙酸后，与那些B12状态正常的人相比，维生素B12缺乏的人呼吸中13CO2的量似乎不那么强烈。在第一阶段，我们计划证明呼气测试区分维生素B12充足和缺乏的个体，并且呼气测试随着治疗的变化而改变。 早期筛查和及时诊断维生素B12缺乏症将防止毁灭性的并发症。扭转神经系统并发症的机会很小。治疗的任何延误都可能导致认知功能很少或根本没有改善。为医生提供诊断维生素B12缺乏症的准确、低成本的工具不仅将改善患者的护理，而且具有成本效益，因为一旦发现这种情况，就可以成功且廉价地进行治疗。