NCT05480943

Prevalence of Thiamine Deficiency in Hospitalized Non-Alcoholic Veterans

Completed Results posted Last updated 29 January 2026

What this trial tests

trial testing Thiamine repletion in Thiamine Deficiency in 206 participants. Completed in 30 December 2024.

Timeline

19 July 2022

Primary endpoint
30 September 2024

30 December 2024

Quick facts

Lead sponsor	VA Office of Research and Development
Status	Completed
Study type	OBSERVATIONAL
Enrollment	206
Start date	19 July 2022
Primary completion	30 September 2024
Estimated completion	30 December 2024
Sites	1 location across United States

Drugs / interventions tested

• Thiamine repletion

Conditions studied

• Thiamine Deficiency — all drugs for Thiamine Deficiency →
• Thiamine Deficiency; Sequelae — all drugs for Thiamine Deficiency; Sequelae →

Sponsor

VA Office of Research and Development — full company profile →

Who can join

18 and older, any sex, with Thiamine Deficiency or Thiamine Deficiency; Sequelae. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

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

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.

Group	Value	95% CI
Enrolled Veterans With Plasma Thiamine Results	49

Association of Thiamine Deficiency and Inflammation Secondary · Baseline

Determine if there is an association between thiamine deficiency defined by low plasma thiamine levels, and elevated highly sensitive C-reactive protein indicating inflammation.

Normal CRP

Group	Value	95% CI
Enrolled Veterans With Both Plasma Thiamine and CRP Results Who Were Thiamine Deficient	8

Elevated CRP

Group	Value	95% CI
Enrolled Veterans With Both Plasma Thiamine and CRP Results Who Were Thiamine Deficient	25

Adverse events — posted to ClinicalTrials.gov

Time frame: two months. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Hospitalized Non-alcoholic Veterans

Serious: 0/181 (0%)

Deaths: 23/181

Other adverse events (1 terms — click to expand)

Reaction	System	Hospitalized Non-alcoholic…
Diarrhea	Gastrointestinal disorders	—

Data from ClinicalTrials.gov NCT05480943 adverse events section.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Thiamine and Micronutrient Deficiencies in Hospitalized Veterans Without Alcohol Use Disorder.
   Mates EA, Watkins K, Sanchez C, Fiore N, et al · · 2026 · PMID 41891996 · DOI 10.3390/diseases14030095