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Oral Intradialytic Amino Acids Supplementation to Vitalize End-stage Kidney Disease Patients on Hemodialysis (OASIS)


Description

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.This single center outpatient study will test and compare the efficacy of a single essential amino acid, valine with a combination of essential amino acids (EAA) supplementation on fatigue, fragility and cognitive function in end-stage kidney disease (ESKD) patients aged 18-64 years undergoing hemodialysis (HD) treatment at least three times a week.

Trial Eligibility

Inclusion Criteria: 1. Male or Female 2. Age 18-64 years 3. Receiving 3 x weekly in clinic hemodialysis for at least 6 months Exclusion Criteria: 1. Hypersensitivity to amino acid(s) and/or any excipient 2. Clinical documentation of COVID-19 3. Concomitant intake of amino acids supplements 4. Current use or abuse of alcohol, marijuana, narcotic, or other substances 5. Heart failure receiving active management 6. Malignant cancer receiving anticancer therapy 7. Diagnosis of major depressive disorder receiving antidepressants 8. Diagnosis of chronic liver disease 9. Cerebrovascular disease with sequelae 10. 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.

Study Info

Organization

The University of Texas Health Science Center at San Antonio


Primary Outcome

Brief Fatigue Inventory (BFI) score


Outcome Timeframe Baseline to 17 weeks

NCTID NCT05705414

Phases EARLY_PHASE1

Primary Purpose TREATMENT

Start Date 2024-10-18

Completion Date 2025-12

Enrollment Target 28

Interventions

DRUG Valine

DRUG EEA

Locations Recruiting

The University of Texas Health Science Center at San Antonio

United States, Texas, San Antonio


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