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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05480943
Other study ID # F4101-P
Secondary ID IRBNet ID 186736
Status Recruiting
Phase
First received
Last updated
Start date July 1, 2022
Est. completion date June 30, 2024

Study information

Verified date February 2024
Source VA Office of Research and Development
Contact Elisabeth A Mates, MD PhD
Phone (775) 786-7200
Email Elisabeth.Mates@va.gov
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Description:

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Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
United States VA Sierra Nevada Health Care System, Reno, NV Reno Nevada

Sponsors (2)

Lead Sponsor Collaborator
VA Office of Research and Development VA Sierra Nevada Health Care System

Country where clinical trial is conducted

United States, 

References & Publications (6)

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Outcome

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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