RecruitingEarly Phase 1

Oral Intradialytic Amino Acid Supplementation to Vitalize End-stage Kidney Disease Patients on Hemodialysis

United States28 participantsStarted 2024-10-18

Plain-language summary

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 participate

Age range18 Years – 64 Years

SexALL

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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

What they're measuring

Brief Fatigue Inventory (BFI) score

Timeframe: Baseline to 17 weeks

Trial details

NCT IDNCT05705414

SponsorThe University of Texas Health Science Center at San Antonio

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-06

Contact for this trial

Subrata Debnath, PhD

210-567-4700 nath@uthscsa.edu

View on ClinicalTrials.gov More End Stage Renal Disease trials