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

Primary Purpose

End Stage Renal Disease

Status
Not yet recruiting
Phase
Early Phase 1
Locations
Study Type
Interventional
Intervention
Valine
EEA
Sponsored by
The University of Texas Health Science Center at San Antonio
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for End Stage Renal Disease focused on measuring Fatigue, End-stage kidney disease, Hemodialysis

Eligibility Criteria

18 Years - 64 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    Treatment group Valine then EEA

    Treatment group EEA then Valine

    Arm Description

    Valine will be administered as two 4 gm packets administered on dialysis treatment day followed by a washout period and then EEA

    EAA will be administered as one 12.5 gm packet administered on dialysis treatment day followed by a washout and then Valine

    Outcomes

    Primary Outcome Measures

    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.

    Secondary Outcome Measures

    Handgrip strength test
    Change in handgrip strength measured by a dynamometer in lbs
    Trail Making Test (TMT)
    Change in minutes to complete Trail Making Test (TMT) A and B

    Full Information

    First Posted
    January 21, 2023
    Last Updated
    August 7, 2023
    Sponsor
    The University of Texas Health Science Center at San Antonio
    Collaborators
    National Center for Advancing Translational Sciences (NCATS), IIMS-UT Health San Antonio
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05705414
    Brief Title
    Oral Intradialytic Amino Acid Supplementation to Vitalize End-stage Kidney Disease Patients on Hemodialysis
    Acronym
    OASIS
    Official Title
    Oral Intradialytic Amino Acids Supplementation to Vitalize End-stage Kidney Disease Patients on Hemodialysis (OASIS)
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    September 2023 (Anticipated)
    Primary Completion Date
    February 2024 (Anticipated)
    Study Completion Date
    August 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    The University of Texas Health Science Center at San Antonio
    Collaborators
    National Center for Advancing Translational Sciences (NCATS), IIMS-UT Health San Antonio

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    Yes
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    End Stage Renal Disease
    Keywords
    Fatigue, End-stage kidney disease, Hemodialysis

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Early Phase 1
    Interventional Study Model
    Crossover Assignment
    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)
    Masking Description
    The intervention will be administered to the subjects by appropriately trained delegates.
    Allocation
    Randomized
    Enrollment
    28 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Treatment group Valine then EEA
    Arm Type
    Experimental
    Arm Description
    Valine will be administered as two 4 gm packets administered on dialysis treatment day followed by a washout period and then EEA
    Arm Title
    Treatment group EEA then Valine
    Arm Type
    Experimental
    Arm Description
    EAA will be administered as one 12.5 gm packet administered on dialysis treatment day followed by a washout and then Valine
    Intervention Type
    Drug
    Intervention Name(s)
    Valine
    Other Intervention Name(s)
    Valine Amino Acid Supplement
    Intervention Description
    A medical food intended for use under medical supervision
    Intervention Type
    Drug
    Intervention Name(s)
    EEA
    Other Intervention Name(s)
    Essential Amino Acid Supplement
    Intervention Description
    A medical food intended for use under medical supervision
    Primary Outcome Measure Information:
    Title
    Brief Fatigue Inventory (BFI) score
    Description
    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.
    Time Frame
    Baseline to 17 weeks
    Secondary Outcome Measure Information:
    Title
    Handgrip strength test
    Description
    Change in handgrip strength measured by a dynamometer in lbs
    Time Frame
    Baseline to 17 weeks
    Title
    Trail Making Test (TMT)
    Description
    Change in minutes to complete Trail Making Test (TMT) A and B
    Time Frame
    Baseline to 17 weeks
    Other Pre-specified Outcome Measures:
    Title
    Dialysate level of amino acids
    Description
    How is this measured, are there different values for different aa's (if so each one should be reported separately)?
    Time Frame
    Baseline to 17 weeks
    Title
    Plasma level of amino acids
    Description
    How is this measured, are there different values for different aa's (if so each one should be reported separately)?
    Time Frame
    Baseline to 17 weeks
    Title
    Blood valine metabolite 3-hydroxyisobutyrate (3-HIB)
    Description
    Change in 3-hydroxyisobutyrate (3-HIB) levels
    Time Frame
    Baseline to 17 weeks
    Title
    Blood valine beta-amino-isobutyric acid (BAIBA)
    Description
    Change in beta-amino-isobutyric acid (BAIBA)
    Time Frame
    Baseline to 17 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    64 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Subrata Debnath, PhD
    Phone
    210-567-4700
    Email
    nath@uthscsa.edu
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Subrata Debnath, PhD
    Organizational Affiliation
    University of Texas Health Science Center San Antonio
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes
    IPD Sharing Plan Description
    This study will comply with the NIH Data Sharing Policy and Policy on the Dissemination of NIH-Funded Clinical Trial Information and the Clinical Trials Registration and Results Information Submission rule. As such, this trial will be registered at ClinicalTrials.gov, and results information from this trial will be submitted to ClinicalTrials.gov. In addition, every attempt will be made to publish results in peer-reviewed journals.
    IPD Sharing Time Frame
    At study completion, once data is published in a peer review journal

    Learn more about this trial

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

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