Oral Intradialytic Amino Acid Supplementation to Vitalize End-stage Kidney Disease Patients on Hemodialysis
Recruiting · NCT05705414 · Interventional (participants receive a specific treatment) · Lead sponsor: The University of Texas Health Science Center at San Antonio
View the official record on ClinicalTrials.gov →Interventions studied
EEAValine
What this trial is about
The study will test and compare the efficacy of a single essential amino acid valine with a combination of essential amino acids (EAA) supplement on fatigue, frailty, and cognitive function in end-stage kidney disease (ESKD) patients undergoing hemodialysis (HD) treatment.
Who can take part
Age range
18 Years to 64 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Early Phase 1
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- Male or Female
- Age 18-64 years
- Receiving 3 x weekly in clinic hemodialysis for at least 6 months
Exclusion criteria
- Hypersensitivity to amino acid(s) and/or any excipient
- Clinical documentation of COVID-19
- Concomitant intake of amino acids supplements
- Current use or abuse of alcohol, marijuana, narcotic, or other substances
- Heart failure receiving active management
- Malignant cancer receiving anticancer therapy
- Diagnosis of major depressive disorder receiving antidepressants
- Diagnosis of chronic liver disease
- Cerebrovascular disease with sequelae
- Upper limb amputation, osteoarthritis, or degenerative diseases of fingers, carpel tunnel syndrome in the non-fistula or graft hand preventing completion of hand grip strength test.
Where it is running
1 location listed across 1 US state.
- The University of Texas Health Science Center at San Antonio - San Antonio, Texas, United States