- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05705414
Oral Intradialytic Amino Acid Supplementation to Vitalize End-stage Kidney Disease Patients on Hemodialysis (OASIS)
March 11, 2024 updated by: The University of Texas Health Science Center at San Antonio
Oral Intradialytic Amino Acids Supplementation to Vitalize End-stage Kidney Disease Patients on Hemodialysis (OASIS)
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.
Study Overview
Status
Not yet recruiting
Conditions
Intervention / 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.
Study Type
Interventional
Enrollment (Estimated)
28
Phase
- Early Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Subrata Debnath, PhD
- Phone Number: 210-567-4700
- Email: nath@uthscsa.edu
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 64 years (Adult)
Accepts Healthy Volunteers
No
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Treatment group Valine then EEA
Valine will be administered as two 4 gm packets administered on dialysis treatment day followed by a washout period and then EEA
|
A medical food intended for use under medical supervision
Other Names:
A medical food intended for use under medical supervision
Other Names:
|
Experimental: Treatment group EEA then Valine
EAA will be administered as one 12.5 gm packet administered on dialysis treatment day followed by a washout and then Valine
|
A medical food intended for use under medical supervision
Other Names:
A medical food intended for use under medical supervision
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Brief Fatigue Inventory (BFI) score
Time Frame: Baseline to 17 weeks
|
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
Time Frame: Baseline to 17 weeks
|
Change in handgrip strength measured by a dynamometer in lbs
|
Baseline to 17 weeks
|
Trail Making Test (TMT)
Time Frame: Baseline to 17 weeks
|
Change in minutes to complete Trail Making Test (TMT) A and B
|
Baseline to 17 weeks
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Dialysate level of amino acids
Time Frame: Baseline to 17 weeks
|
How is this measured, are there different values for different aa's (if so each one should be reported separately)?
|
Baseline to 17 weeks
|
Plasma level of amino acids
Time Frame: Baseline to 17 weeks
|
How is this measured, are there different values for different aa's (if so each one should be reported separately)?
|
Baseline to 17 weeks
|
Blood valine metabolite 3-hydroxyisobutyrate (3-HIB)
Time Frame: Baseline to 17 weeks
|
Change in 3-hydroxyisobutyrate (3-HIB) levels
|
Baseline to 17 weeks
|
Blood valine beta-amino-isobutyric acid (BAIBA)
Time Frame: Baseline to 17 weeks
|
Change in beta-amino-isobutyric acid (BAIBA)
|
Baseline to 17 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Subrata Debnath, PhD, University of Texas Health Science Center San Antonio
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
May 1, 2024
Primary Completion (Estimated)
December 1, 2025
Study Completion (Estimated)
March 1, 2026
Study Registration Dates
First Submitted
January 21, 2023
First Submitted That Met QC Criteria
January 21, 2023
First Posted (Actual)
January 30, 2023
Study Record Updates
Last Update Posted (Actual)
March 12, 2024
Last Update Submitted That Met QC Criteria
March 11, 2024
Last Verified
March 1, 2024
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- HSC20220558H
- KL2TR002646 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD 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
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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