NCT05705414 · The University of Texas Health Science Center at San Antonio
Oral Intradialytic Amino Acid Supplementation to Vitalize End-stage Kidney Disease Patients on Hemodialysis
(OASIS)
What this study is about
The study will test and compare the effectiveness 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.
View original scientific 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.
Interventions
DRUG
Valine
A medical food intended for use under medical supervision
DRUG
EEA
A medical food intended for use under medical supervision
Primary outcome measures
Brief Fatigue Inventory (BFI) score
Time frame: Baseline to 17 weeks
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
- San Antonio, Texas
Collaborators
National Center for Advancing Translational Sciences (NCATS), IIMS-UT Health San Antonio
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jan 6, 2026 · Source of record for eligibility and locations