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Clinical Trial Details

Trial ID: L0883
Source ID: NCT05705414
Associated Drug: Valine
Title: Oral Intradialytic Amino Acid Supplementation to Vitalize End-stage Kidney Disease Patients on Hemodialysis
Acronym: OASIS
Status: RECRUITING
Study Results: NO
Results:
Conditions: End Stage Renal Disease
Interventions: DRUG: Valine|DRUG: EEA
Outcome Measures: Primary: Brief Fatigue Inventory (BFI) score, Changes in global fatigue score measured with the 9-item Brief Fatigue Inventory (BFI). The first 3 questions assess fatigue severity, and the remaining 6 questions measure the impact of fatigue on activity, mood, walking, work, relationships, and enjoyment of life. Respondents rate each item on a 0-10 numeric scale, with 0 meaning "no fatigue" and 10 meaning "fatigue as bad as you can imagine." Scores of all 9 items yield global fatigue burden. A lower average global fatigue score indicates milder fatigue and a higher score severe fatigue., Baseline to 17 weeks | Secondary: Handgrip strength test, Change in handgrip strength measured by a dynamometer in lbs, Baseline to 17 weeks|Trail Making Test (TMT), Change in minutes to complete Trail Making Test (TMT) A and B, Baseline to 17 weeks | Other: Dialysate level of amino acids, How is this measured, are there different values for different aa's (if so each one should be reported separately)?, Baseline to 17 weeks|Plasma level of amino acids, How is this measured, are there different values for different aa's (if so each one should be reported separately)?, Baseline to 17 weeks|Blood valine metabolite 3-hydroxyisobutyrate (3-HIB), Change in 3-hydroxyisobutyrate (3-HIB) levels, Baseline to 17 weeks|Blood valine beta-amino-isobutyric acid (BAIBA), Change in beta-amino-isobutyric acid (BAIBA), Baseline to 17 weeks
Sponsor/Collaborators: Sponsor: The University of Texas Health Science Center at San Antonio | Collaborators: National Center for Advancing Translational Sciences (NCATS)|IIMS-UT Health San Antonio
Gender: ALL
Age: ADULT
Phases: EARLY_PHASE1
Enrollment: 28
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-10-18
Completion Date: 2026-03
Results First Posted:
Last Update Posted: 2024-11-29
Locations: The University of Texas Health Science Center at San Antonio, San Antonio, Texas, 78229, United States
URL: https://clinicaltrials.gov/show/NCT05705414