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Amino Acid Supplement
Amino Acid Supplementation for Kidney Disease (OASIS Trial)
Phase < 1
Recruiting
Led By Subrata Debnath, PhD
Research Sponsored by The University of Texas Health Science Center at San Antonio
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Age 18-64 years
Receiving 3 x weekly in clinic hemodialysis for at least 6 months
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to 17 weeks
Awards & highlights
No Placebo-Only Group
Summary
This trial will compare how effective a single amino acid called valine is against a combination of different amino acids in helping kidney disease patients on dialysis with their fatigue, weakness, and thinking abilities.
Who is the study for?
This trial is for men and women aged 18-64 who have end-stage kidney disease and have been receiving in-clinic hemodialysis three times a week for at least six months. It's not specified who can't join, but typically those with other serious health issues or conditions that could interfere with the study might be excluded.
What is being tested?
The study aims to see if taking the amino acid valine alone or a mix of essential amino acids (EEA) can help reduce fatigue, frailty, and improve thinking skills in patients on hemodialysis due to severe kidney disease.
What are the potential side effects?
While specific side effects are not listed, amino acid supplements may sometimes cause nausea, cramps, diarrhea, pain where injected (if applicable), and allergic reactions. Close monitoring will likely minimize risks.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 18 and 64 years old.
Select...
I have been on hemodialysis 3 times a week for at least 6 months.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline to 17 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to 17 weeks
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Brief Fatigue Inventory (BFI) score
Secondary study objectives
Handgrip strength test
Trail Making Test (TMT)
Other study objectives
Blood valine beta-amino-isobutyric acid (BAIBA)
Blood valine metabolite 3-hydroxyisobutyrate (3-HIB)
Dialysate level of amino acids
+1 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Group I: Treatment group Valine then EEAExperimental Treatment2 Interventions
Valine will be administered as two 4 gm packets administered on dialysis treatment day followed by a washout period and then EEA
Group II: Treatment group EEA then ValineExperimental Treatment2 Interventions
EAA will be administered as one 12.5 gm packet administered on dialysis treatment day followed by a washout and then Valine
Find a Location
Who is running the clinical trial?
The University of Texas Health Science Center at San AntonioLead Sponsor
476 Previous Clinical Trials
92,882 Total Patients Enrolled
National Center for Advancing Translational Sciences (NCATS)NIH
377 Previous Clinical Trials
412,999 Total Patients Enrolled
IIMS-UT Health San AntonioUNKNOWN
1 Previous Clinical Trials
150 Total Patients Enrolled
Subrata Debnath, PhDPrincipal InvestigatorUniversity of Texas Health Science Center San Antonio