Clinical trial NCT05705414: Oral Intradialytic Amino Acid Supplementation to Vitalize End-stage Kidney Disease Patients on Hemodialysis
Official title: Oral Intradialytic Amino Acids Supplementation to Vitalize End-stage Kidney Disease Patients on Hemodialysis (OASIS)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: EARLY_PHASE1
Conditions: End Stage Renal Disease
Keywords: Fatigue
End-stage kidney disease
Hemodialysis
Lead sponsor: The University of Texas Health Science Center at San Antonio
Sponsor class: OTHER
Collaborators: name: National Center for Advancing Translational Sciences (NCATS)
name: IIMS-UT Health San Antonio
First posted: 2023-01-30
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: The study design will consist of a crossover schema, with one arm starting on amino acid Valine and the other on EAA for a period of 8 weeks, followed by a washout period of 1 week, and then assignment to the nutritional supplement that they have not already taken for the remaining 8 week period that they are participating in this study.
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: This single center outpatient study will test and compare the efficacy of a single essential amino acid, valine with a combination of essential amino acids (EAA) supplementation on fatigue, fragility and cognitive function in end-stage kidney disease (ESKD) patients aged 18-64 years undergoing hemodialysis (HD) treatment at least three times a week.

Eligibility 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.

Primary outcomes:
measure: Brief Fatigue Inventory (BFI) score
timeFrame: Baseline to 17 weeks
Secondary outcomes:
measure: Handgrip strength test
timeFrame: Baseline to 17 weeks
measure: Trail Making Test (TMT)
timeFrame: Baseline to 17 weeks
Other outcomes:
measure: Dialysate level of amino acids
timeFrame: Baseline to 17 weeks
measure: Plasma level of amino acids
timeFrame: Baseline to 17 weeks
measure: Blood valine metabolite 3-hydroxyisobutyrate (3-HIB)
timeFrame: Baseline to 17 weeks
measure: Blood valine beta-amino-isobutyric acid (BAIBA)
timeFrame: Baseline to 17 weeks
Locations:
city: San Antonio
country: United States
facility: The University of Texas Health Science Center at San Antonio
state: Texas
Study officials:
affiliation: University of Texas Health Science Center San Antonio
name: Subrata Debnath, PhD
role: PRINCIPAL_INVESTIGATOR
References: