Amino acid supplementation for patients with end-stage kidney disease on hemodialysis
Oral Intradialytic Amino Acids Supplementation to Vitalize End-stage Kidney Disease Patients on Hemodialysis (OASIS)
This study is testing if taking valine or a mix of essential amino acids can help reduce fatigue and improve thinking skills in adults with end-stage kidney disease who are on hemodialysis.
Quick facts
| Phase | Early Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 28 (estimated) |
| Ages | 18 Years to 64 Years |
| Sex | All |
| Sponsor | The University of Texas Health Science Center at San Antonio Academic / other |
| Locations | 1 site (San Antonio, Texas) |
| Trial ID | NCT05705414 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of valine, a single essential amino acid, compared to a combination of essential amino acids (EAA) in reducing fatigue, frailty, and improving cognitive function in patients with end-stage kidney disease (ESKD) who are undergoing hemodialysis. Conducted at a single center, the trial will involve patients aged 18-64 who have been receiving hemodialysis treatment at least three times a week for a minimum of six months. Participants will be monitored for changes in their physical and cognitive health as a result of the supplementation.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18-64 years who have been on hemodialysis for at least six months.
Not a fit: Patients with hypersensitivity to amino acids, current substance abuse, or certain medical conditions such as heart failure or major depressive disorder may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved quality of life and cognitive function for patients with end-stage kidney disease undergoing hemodialysis.
How similar studies have performed: While this approach is relatively novel, previous studies on amino acid supplementation in similar patient populations have shown promising results.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
San Antonio, Texas
- The University of Texas Health Science Center at San Antonio — San Antonio, Texas, United States (Recruiting)
Study contacts
- Principal investigator: Subrata Debnath, PhD — The University of Texas Health Science Center at San Antonio
- Study coordinator: Subrata Debnath, PhD
- Email: nath@uthscsa.edu
- Phone: 210-567-4700
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.