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

Part of paid clinical trials in San Antonio, Texas.

Sponsor
The University of Texas Health Science Center at San Antonio
Study ID
NCT05705414
Phase
EARLY_PHASE1
Status
Recruiting
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Conditions

  • End Stage Renal Disease

Eligibility Criteria

Sex
ALL
Age
18 Years - 64 Years
Healthy Volunteers
Not accepted

Interventions

  • Valine — DRUG
    A medical food intended for use under medical supervision
  • EEA — DRUG
    A medical food intended for use under medical supervision

Study Details

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.

Key Dates

Start date
Oct 18, 2024
Status verified
Jan 2026
Primary completion
Jun 30, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
28 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment group Valine then EEA
    Valine will be administered as two 4 gm packets administered on dialysis treatment day followed by a washout period and then EEA
  • Experimental: Treatment group EEA then Valine
    EAA will be administered as one 12.5 gm packet administered on dialysis treatment day followed by a washout and then Valine

Primary Outcome Measure

Brief Fatigue Inventory (BFI) score [ Time Frame: Baseline to 17 weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
The University of Texas Health Science Center at San AntonioSan AntonioTexas78229
Subrata Debnath, PhD
[email protected]
210-567-4700

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By research site
The University of Texas Health Science Center at San Antonio· San Antonio, TX

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