Oral Intradialytic Amino Acid Supplementation to Vitalize End-stage Kidney Disease Patients on Hemodialysis

Study Overview
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Brief Summary
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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
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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.

Official Title
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Oral Intradialytic Amino Acids Supplementation to Vitalize End-stage Kidney Disease Patients on Hemodialysis (OASIS)

Conditions
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End Stage Renal Disease

Intervention / Treatment
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* Drug: Valine
* Drug: EEA


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 64 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional 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.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment group Valine then EEA<br>Valine will be administered as two 4 gm packets administered on dialysis treatment day followed by a washout period and then EEA | Drug: Valine<br>* A medical food intended for use under medical supervision<br>* Other names: Valine Amino Acid Supplement;Drug: EEA<br>* A medical food intended for use under medical supervision<br>* Other names: Essential Amino Acid Supplement;|
| Experimental: Treatment group EEA then Valine<br>EAA will be administered as one 12.5 gm packet administered on dialysis treatment day followed by a washout and then Valine | Drug: Valine<br>* A medical food intended for use under medical supervision<br>* Other names: Valine Amino Acid Supplement;Drug: EEA<br>* A medical food intended for use under medical supervision<br>* Other names: Essential Amino Acid Supplement;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Fatigue, End-stage kidney disease, Hemodialysis