Mild cognitive impairment (MCI) is a common but underrecognized neurological complication in patients with end-stage kidney disease (ESKD) undergoing maintenance hemodialysis (HD). Cognitive dysfunction in this population is multifactorial and associated with poor quality of life, higher risk of hospitalization, falls, and mortality. Thiamine (vitamin B1) deficiency is a potentially reversible contributor to cognitive impairment in dialysis patients due to altered metabolism and dialysis-related
Conditions
Interventions
Participants in the intervention group will receive intravenous thiamine (vitamin B1) 100 mg administered after each hemodialysis session, three times per week, for a total duration of 12 months. This
Experimental Drug,No Intervention No treatment
Intravenous thiamine ,Standard care
Sponsors
Kidney Foundation of Thailand
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1.Age more than 18 years 2.Receiving maintenance hemodialysis (HD) for at least 3 months 3.Montreal Cognitive Assessment (MoCA) score < 25, indicating mild cognitive impairment (MCI) 4.Able to communicate and understand Thai sufficiently to complete cognitive assessments (MoCA or TMSE)
Exclusion criteria
Exclusion criteria: 1.Moderate to severe dementia, defined by MoCA score below 18 or ICD-10 diagnosis 2.Severe thiamine deficiency (ETKac more than 25 percent) 3.History of encephalopathy, Wernicke encephalopathy, or other CNS disorders affecting cognition 4.Chronic alcoholism or substance abuse 5.Prior use of thiamine more than 100 mg/day or high-dose thiamine supplements in the past 3 months 6.Recent acute severe illness (e.g., sepsis, stroke, acute heart failure) within the past 3 months 7.Known hypersensitivity to thiamine 8.Severe visual or hearing impairment that prevents completion of cognitive assessments 9.Advanced liver disease (Child-Pugh C) or acute liver failure 10.Pregnancy or breastfeeding
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| MoCA Score at 12 months after end of the intervention Change in Montreal Cognitive Assessment (MoCA) | — |
Secondary
| Measure | Time frame |
|---|---|
| Erythrocyte Transketolase Activity Coefficient (ETKac) at 12 months after end of the intervention Change in ETKac,Thai Mental State Examination (TMSE) Score at 12 months after end of the intervention Change in TMSE score,Adverse Events (AEs) at 12 months after end of the intervention Incidence of any treatment-emergent adverse events (TEAEs),Frequency of clinically important events (falls, hospitalizations, mortality) 12 months of study incidence of any clinical events | — |
Countries
Thailand
Contacts
Public ContactWittawat Hongmeng
Faculty of Medicine, Thammasat University
Outcome results
None listed