Prevalence of Thiamine Deficiency in Hospitalized Non-Alcoholic Veterans

NCT05480943 | Completed Results

• 2 other identifiers: F4101-PIRBNet ID 1867369-3
• Study Type: observational
• Target: 206
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Thiamine Deficiency; Sequelae; Thiamine Deficiency

Keywords

thiamine deficiency; Wernicke's encephalopathy; beriberi; delirium; polyneuropathy; vitamin B1; falls

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants With Thiamine Deficiency (Low Plasma Thiamine) Out of Total Number of Enrolled Veterans With Plasma Thiamine Results

  The percentage of enrolled non-alcoholic veterans who have thiamine deficiency (defined as low plasma thiamine levels) out of the total number of enrolled Veterans with plasma thiamine results.

  Baseline

Secondary Outcomes (2)

• Association of Thiamine Deficiency and Inflammation

  Baseline

• Cut-point Analysis of Thiamine Biomarkers

  Baseline compared to follow up visit

Study Arms (1)

Hospitalized non-alcoholic Veterans

Any Veteran with full admission to the VA Sierra Nevada Healthcare System Hospital.

Dietary Supplement: Thiamine repletion

Interventions

Thiamine repletion DIETARY_SUPPLEMENT

If a participant is determined by clinical characteristics or biomarker results to be thiamine deficient, thiamine supplementation was provided.

Hospitalized non-alcoholic Veterans

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Veterans who are admitted to the medicine service at the VA Sierra Nevada Healthcare System hospital in Reno, NV who do not use alcohol to excess. The Veterans will need to live within 75 miles of the medical center to facilitate return for follow up appointments.

You may qualify if:

• full admission to the hospital medical service (not on observation status)

You may not qualify if:

• excess alcohol intake as defined by the National Institute of Alcohol Abuse and Alcoholism
• taking thiamine supplement
• quadriplegic
• lives more than 75 miles from the medical center
• unable to demonstrate capacity to understand the study and provide informed consent

Sponsors & Collaborators

• VA Office of Research and Development: lead
• VA Sierra Nevada Health Care System: collaborator

Study Sites (1)

VA Sierra Nevada Health Care System, Reno, NV

Reno, Nevada, 89502-0993, United States

Location

Related Publications (6)

• 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.

  PMID: 33916273 BACKGROUND

• 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.

  PMID: 33576090 BACKGROUND

• 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.

  PMID: 20646908 BACKGROUND

• 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.

  PMID: 30151974 BACKGROUND

• 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.

  PMID: 11015250 BACKGROUND

• 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.

  PMID: 33305487 BACKGROUND

Biospecimen

Retention: NONE RETAINED

No specimen will be retained.

MeSH Terms

Conditions

Thiamine Deficiency; Wernicke Encephalopathy; Beriberi; Delirium; Polyneuropathies

Condition Hierarchy (Ancestors)

Vitamin B Deficiency; Avitaminosis; Deficiency Diseases; Malnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Brain Diseases, Metabolic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Metabolic Diseases; Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurocognitive Disorders; Peripheral Nervous System Diseases; Neuromuscular Diseases

Limitations and Caveats

Multiple prolonged work stoppages due to unforeseen events led to lower than expected enrollment. Poor compliance with follow up visits after initial evaluation in the hospital.

Results Point of Contact

• Title: Elisabeth Mates, MD,PhD, Principal investigator
• Organization: VA Sierra Nevada Healthcare System

Elisabeth.Mates@va.gov

775-786-7200

Study Officials

• Elisabeth A Mates, MD PhD

  VA Sierra Nevada Health Care System, Reno, NV

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 27, 2022
• First Posted: July 29, 2022
• Study Start: July 19, 2022
• Primary Completion: September 30, 2024
• Study Completion: December 30, 2024
• Last Updated: January 29, 2026
• Results First Posted: October 15, 2025

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)