Trial Outcomes & Findings for Prevalence of Thiamine Deficiency in Hospitalized Non-Alcoholic Veterans (NCT NCT05480943)
NCT ID: NCT05480943
Last Updated: 2026-08-12
Results Overview
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.
COMPLETED
206 participants
Baseline
2026-08-12
Participant Flow
All admissions to the hospital were screened and Veterans were excluded if they reported excess alcohol intake; taking thiamine; lived more than 70 miles from the hospital. Those who passed screening were approached for consent. If they were unable to comprehend and "read back" basic elements of the informed consent (as determined by the U-ARE protocol), they were not included due to prohibitive state laws. The first patient was enrolled on July 19, 2022. The last Veteran was enrolled 8/27/2024.
1713 participants were screened. Of those, 336 were being discharged too soon for study procedures, 322 lived too far away, 211 took thiamine, 149 had alcohol use disorder, 134 were excluded for reasons due to study logistics (e.g. lack of provider to complete exams, patient too busy, etc.), and 99 cognitively could not consent. Of the remaining, 256 did not want to participate and 206 were enrolled.
Participant milestones
| Measure |
Veterans Without Alcohol Use Disorder Admitted to the Hospital
Veterans with full admission to the hospital who did not have alcohol use disorder, lived within 70 miles of the hospital, were able to read back key portions of the consent, and who were not taking thiamine supplements.
|
|---|---|
|
Evaluation for Thiamine Deficiency
STARTED
|
206
|
|
Evaluation for Thiamine Deficiency
Obtained Plasma Thiamine Results
|
181
|
|
Evaluation for Thiamine Deficiency
Answered Interview Questions
|
177
|
|
Evaluation for Thiamine Deficiency
Completed Initial Physical Exam
|
162
|
|
Evaluation for Thiamine Deficiency
COMPLETED
|
162
|
|
Evaluation for Thiamine Deficiency
NOT COMPLETED
|
44
|
|
Suspected Thiamine Deficiency
STARTED
|
124
|
|
Suspected Thiamine Deficiency
COMPLETED
|
60
|
|
Suspected Thiamine Deficiency
NOT COMPLETED
|
64
|
Reasons for withdrawal
| Measure |
Veterans Without Alcohol Use Disorder Admitted to the Hospital
Veterans with full admission to the hospital who did not have alcohol use disorder, lived within 70 miles of the hospital, were able to read back key portions of the consent, and who were not taking thiamine supplements.
|
|---|---|
|
Evaluation for Thiamine Deficiency
Lost to Follow-up
|
31
|
|
Evaluation for Thiamine Deficiency
Protocol Violation
|
12
|
|
Evaluation for Thiamine Deficiency
Withdrawal by Subject
|
1
|
|
Suspected Thiamine Deficiency
Lost to Follow-up
|
64
|
Baseline Characteristics
181 with plasma thiamine biomarker results
Baseline characteristics by cohort
| Measure |
Hospitalized Non-alcoholic Veterans
n=206 Participants
Veterans with full admission to the VA Sierra Nevada Healthcare System Hospital who do not have alcohol use disorder (AUD).
|
|---|---|
|
Age, Continuous
|
70.33 years
STANDARD_DEVIATION 11.53 • n=206 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
196 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
6 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
193 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
7 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
5 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
11 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
175 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
12 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
206 Participants
n=206 Participants
|
|
Plasma thiamine level
Low plasma thiamine
|
49 Participants
n=181 Participants • 181 with plasma thiamine biomarker results
|
|
Plasma thiamine level
Normal plasma thiamine
|
132 Participants
n=181 Participants • 181 with plasma thiamine biomarker results
|
|
Highly sensitive C-reactive protein
Normal C-reactive protein
|
38 Participants
n=125 Participants • Only 125 participants had C-reactive protein lab results
|
|
Highly sensitive C-reactive protein
Elevated C-reactive protein
|
87 Participants
n=125 Participants • Only 125 participants had C-reactive protein lab results
|
PRIMARY outcome
Timeframe: BaselinePopulation: Enrollees with plasma thiamine levels
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.
Outcome measures
| Measure |
Enrolled Veterans With Plasma Thiamine Results
n=181 Participants
Enrolled Hospitalized non-alcoholic Veterans with plasma thiamine results.
|
|---|---|
|
Percentage of Participants With Thiamine Deficiency (Low Plasma Thiamine) Out of Total Number of Enrolled Veterans With Plasma Thiamine Results
|
49 Participants
|
SECONDARY outcome
Timeframe: BaselinePopulation: Participants with results of both plasma thiamine level and C-reactive protein who were thiamine deficient were analyzed to determine if there was an association between thiamine deficiency and increased inflammation.
Determine if there is an association between thiamine deficiency defined by low plasma thiamine levels, and elevated highly sensitive C-reactive protein indicating inflammation.
Outcome measures
| Measure |
Enrolled Veterans With Plasma Thiamine Results
n=33 Participants
Enrolled Hospitalized non-alcoholic Veterans with plasma thiamine results.
|
|---|---|
|
Association of Thiamine Deficiency and Inflammation
Normal CRP
|
8 Participants
|
|
Association of Thiamine Deficiency and Inflammation
Elevated CRP
|
25 Participants
|
SECONDARY outcome
Timeframe: Follow up at 4 weeksThiamine deficiency symptoms and physical exam findings of ophthalmoplegia, muscle weakness, and ataxia received a score before thiamine repletion and after. Each component was scaled equally and combined into a composite score before and after treatment. The investigators used receiver operator characteristic analysis to find the value of plasma thiamine concentration below which most individuals improved with specificity of 0.5 or higher. The resulting analysis showed the value of plasma thiamine in nmol/L resulting in a specificity of 0.5 or higher which was determined to be the optimal cut point of plasma thiamine concentration to identify individuals with clinically relevant thiamine deficiency.
Outcome measures
| Measure |
Enrolled Veterans With Plasma Thiamine Results
n=60 Participants
Enrolled Hospitalized non-alcoholic Veterans with plasma thiamine results.
|
|---|---|
|
Cut Point Analysis of Plasma Thiamine Concentration (Nanomoles/Liter) Below Which Most Participants Composite Thiamine Deficiency Symptom Score Improved With Thiamine Repletion
|
8.5 nanomoles/liter
|
Adverse Events
Hospitalized Non-alcoholic Veterans
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Hospitalized Non-alcoholic Veterans
n=181 participants at risk
Veterans with full admission to the hospital who did not have alcohol use disorder, lived within 70 miles of the hospital, were able to read back key portions of the consent, and who were not taking thiamine supplements.
|
|---|---|
|
Gastrointestinal disorders
Diarrhea
|
0.55%
1/181 • two months
|
Additional Information
Elisabeth Mates, MD,PhD, Principal investigator
VA Sierra Nevada Healthcare System
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place