Thiamine Deficiency Clinical Trial
Official title:
Prevalence of Thiamine Deficiency in Hospitalized Non-Alcoholic Veterans
Thiamine micronutrient deficiency (TD) can cause a variety of non-specific symptoms and leads to several thiamine deficiency disorders such as heart failure, polyneuropathy, Wernicke's Encephalopathy and generalized weakness and debility. Symptoms are often vague and non-specific such as fatigue, leg swelling, imbalance, confusion, mood disorders, gastrointestinal upset, and weakness. Hospitalized Veterans may be particularly susceptible to TD due to food insecurity and chronic illnesses which cause inflammation and increased metabolic demands. This study aims to determine the prevalence of TD in hospitalized Veterans which has never been done before. The investigators also seek to identify risk factors causing TD including acute and chronic forms of inflammation, food insecurity, and dietary habits. Lastly, the investigators hope to clarify the abnormally low levels of blood thiamine that correlate with symptoms of TD that improve with replenishment.
Status | Recruiting |
Enrollment | 200 |
Est. completion date | June 30, 2024 |
Est. primary completion date | June 30, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - full admission to the hospital medical service (not on observation status) Exclusion Criteria: - excess alcohol intake as defined by the National Institute of Alcohol Abuse and Alcoholism - taking thiamine supplement - quadriplegic - lives more than 30 miles from the medical center - unable to demonstrate capacity to understand the study and provide informed consent |
Country | Name | City | State |
---|---|---|---|
United States | VA Sierra Nevada Health Care System, Reno, NV | Reno | Nevada |
Lead Sponsor | Collaborator |
---|---|
VA Office of Research and Development | VA Sierra Nevada Health Care System |
United States,
Donnino MW, Carney E, Cocchi MN, Barbash I, Chase M, Joyce N, Chou PP, Ngo L. Thiamine deficiency in critically ill patients with sepsis. J Crit Care. 2010 Dec;25(4):576-81. doi: 10.1016/j.jcrc.2010.03.003. Epub 2010 Jun 19. — View Citation
Gomes F, Bergeron G, Bourassa MW, Fischer PR. Thiamine deficiency unrelated to alcohol consumption in high-income countries: a literature review. Ann N Y Acad Sci. 2021 Aug;1498(1):46-56. doi: 10.1111/nyas.14569. Epub 2021 Feb 11. — View Citation
Lee DC, Chu J, Satz W, Silbergleit R. Low plasma thiamine levels in elder patients admitted through the emergency department. Acad Emerg Med. 2000 Oct;7(10):1156-9. doi: 10.1111/j.1553-2712.2000.tb01268.x. — View Citation
Mates E, Alluri D, Artis T, Riddle MS. A Retrospective Case Series of Thiamine Deficiency in Non-Alcoholic Hospitalized Veterans: An Important Cause of Delirium and Falling? J Clin Med. 2021 Apr 1;10(7):1449. doi: 10.3390/jcm10071449. — View Citation
Smith TJ, Johnson CR, Koshy R, Hess SY, Qureshi UA, Mynak ML, Fischer PR. Thiamine deficiency disorders: a clinical perspective. Ann N Y Acad Sci. 2021 Aug;1498(1):9-28. doi: 10.1111/nyas.14536. Epub 2020 Dec 10. — View Citation
Whitfield KC, Bourassa MW, Adamolekun B, Bergeron G, Bettendorff L, Brown KH, Cox L, Fattal-Valevski A, Fischer PR, Frank EL, Hiffler L, Hlaing LM, Jefferds ME, Kapner H, Kounnavong S, Mousavi MPS, Roth DE, Tsaloglou MN, Wieringa F, Combs GF Jr. Thiamine deficiency disorders: diagnosis, prevalence, and a roadmap for global control programs. Ann N Y Acad Sci. 2018 Oct;1430(1):3-43. doi: 10.1111/nyas.13919. Epub 2018 Aug 27. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Prevalence of thiamine deficiency in non-alcoholic hospitalized veterans | Determine the percentage of non-alcoholic veterans who are admitted to the hospital who have thiamine deficiency by thiamine biomarkers or by symptoms that improve with thiamine replenishment | 21 days | |
Secondary | Cut-point analysis of thiamine biomarkers | The investigators will determine the low end of normal thiamine levels in veterans with treatment-responsive thiamine deficiency symptoms | 21 days | |
Secondary | Correlation of thiamine deficiency with inflammation | Determine if there is a correlation between thiamine deficiency disorders and biomarkers of inflammation or the presence of inflammatory conditions | 1 day |
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