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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

基本信息

批准号：
7279851
负责人：
DAVID A WAGNER
金额：
$ 38.66万
依托单位：
METABOLIC SOLUTIONS, INC.
依托单位国家：
美国
项目类别：
财政年份：
2003
资助国家：
美国
起止时间：
2003-04-01 至 2009-08-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/7279851
关键词：
15 year old Achlorhydria Acids Address Adopted Affect Age Alzheimer&apos s Disease Applications Grants Area Atrophic Gastritis Back Binding Biological Assay Biological Markers Breath Tests Businesses Carbon Dioxide Characteristics Citric Acid Cycle Client Clinical Clinical Research Coenzyme A Collection Condition Confusion Data Dementia Detection Development Diagnosis Diagnostic Diagnostic tests Disease Dose Drug Formulations Elderly Equilibrium Equipment Esthesia Fasting Gastric Acid Goals Grant Helicobacter pylori Homocysteine Homocystine Hour Hypochlorhydria Individual Invasive Label Laboratories Lead Life Malabsorption Syndromes Malignant Neoplasms Marketing Measurement Medical Metabolic Metabolism Methylmalonic Acid Minority Monitor Morbidity - disease rate Numbers Output Participant Pathway interactions Patients Performance Persons Pharmaceutical Preparations Pharmacologic Substance Phase Phase I Clinical Trials Physicians Physicians&apos Offices Population Prevalence Primary Care Physician Procedures Propionates Protein Binding Proteins Protocols documentation Quality of life Radioactive Range Reference Values Reporting Research Infrastructure Risk Sampling Sensitivity and Specificity Serum Services Signs and Symptoms Sodium Sodium propionate Solutions Specificity Stable Isotope Labeling Staging Stomach Supplementation Symptoms Target Populations Test Result Testing Tracer Tube United States Food and Drug Administration Urea Validation Vitamin B 12 Vitamin B 12 Deficiency Vitamins Walking Writing base clinical Diagnosis commercial application concept cost day expectation instrument neuropsychiatry novel diagnostics point of care pre-clinical response stable isotope succinyl-coenzyme A technological innovation vibration

项目摘要

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缺乏症是一个常见的问题，影响美国普通人群，特别是老年人。老年人由于年龄增长而增加了维生素B12吸收不良和萎缩性胃炎的存在，因此处于临床前维生素B12缺乏症的风险中。老年人缺乏维生素B12可能会导致严重的并发症，包括痴呆症、阿尔茨海默病和癌症。目前诊断B12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B12呼吸测试（BBT），将具有非侵入性，易于管理和保质期长的优点。BBT将允许医生以比目前诊断测试低得多的成本准确地测试B12缺乏症。我们的目标是在临床前阶段确定维生素B12缺乏症，此时治疗可以避免并发症。诊断这种缺乏症是有意义的，因为一旦确定为一个问题，它可以有效地和廉价地治疗适当的维生素B12补充剂。这将导致整体医疗成本降低，因为这种情况很快被发现并得到适当的治疗。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，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B12状态的个体相比，维生素B12缺乏个体的呼吸中13 CO2的量减少。第一阶段赠款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，以降低测试成本并简化测试。具体来说，我们将检查一个较小剂量的丙酸盐，一个单一的20分钟的呼吸收集和消除需要在禁食状态超过1小时。第三阶段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目前的临床实验室客户，其他独立的临床实验室和1,000多个拥有即时呼吸检测设备的医生实验室。项目叙述：维生素B12缺乏症是老年人常见的问题，由于没有准确和低成本的诊断测试，很难早期发现。缺乏维生素B12可能会导致严重的并发症，包括痴呆症、阿尔茨海默病和癌症。该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。