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

Sponsor

The University of Texas Health Science Center at San Antonio (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05705414

Collaborator

National Center for Advancing Translational Sciences (NCATS) (NIH), IIMS-UT Health San Antonio (Other)

Enrollment

Arms

17.1

Anticipated Duration (Months)

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
End Stage Renal Disease	Drug: Valine Drug: EEA	Early Phase 1

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 Design

Study Type:

Interventional

Anticipated Enrollment :

28 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

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.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.

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Mar 1, 2023

Anticipated Primary Completion Date :

Feb 1, 2024

Anticipated Study Completion Date :

Aug 1, 2024

Arms and Interventions

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	Drug: Valine A medical food intended for use under medical supervision Other Names: Valine Amino Acid Supplement Drug: EEA A medical food intended for use under medical supervision Other Names: Essential Amino Acid Supplement
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	Drug: Valine A medical food intended for use under medical supervision Other Names: Valine Amino Acid Supplement Drug: EEA A medical food intended for use under medical supervision Other Names: Essential Amino Acid Supplement

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

Drug: Valine

A medical food intended for use under medical supervision

Other Names:

Valine Amino Acid Supplement

Drug: EEA

A medical food intended for use under medical supervision

Other Names:

Essential Amino Acid Supplement

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

Drug: Valine

A medical food intended for use under medical supervision

Other Names:

Valine Amino Acid Supplement

Drug: EEA

A medical food intended for use under medical supervision

Other Names:

Essential Amino Acid Supplement

Outcome Measures

Primary Outcome Measures

Brief Fatigue Inventory (BFI) score [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.

Secondary Outcome Measures

Handgrip strength test [Baseline to 17 weeks]
Change in handgrip strength measured by a dynamometer in lbs
Trail Making Test (TMT) [Baseline to 17 weeks]
Change in minutes to complete Trail Making Test (TMT) A and B

Other Outcome Measures

Dialysate level of amino acids [Baseline to 17 weeks]
How is this measured, are there different values for different aa's (if so each one should be reported separately)?
Plasma level of amino acids [Baseline to 17 weeks]
How is this measured, are there different values for different aa's (if so each one should be reported separately)?
Blood valine metabolite 3-hydroxyisobutyrate (3-HIB) [Baseline to 17 weeks]
Change in 3-hydroxyisobutyrate (3-HIB) levels
Blood valine beta-amino-isobutyric acid (BAIBA) [Baseline to 17 weeks]
Change in beta-amino-isobutyric acid (BAIBA)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 64 Years

Sexes Eligible for Study:

All

Accepts 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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

The University of Texas Health Science Center at San Antonio
National Center for Advancing Translational Sciences (NCATS)
IIMS-UT Health San Antonio

Investigators

Principal Investigator: Subrata Debnath, PhD, University of Texas Health Science Center San Antonio

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

The University of Texas Health Science Center at San Antonio

ClinicalTrials.gov Identifier:

NCT05705414

Other Study ID Numbers:

HSC20220558H
KL2TR002646

First Posted:

Jan 30, 2023

Last Update Posted:

Jan 30, 2023

Last Verified:

Jan 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Keywords provided by The University of Texas Health Science Center at San Antonio

Fatigue, end-stage kidney disease, hemodialysis

Additional relevant MeSH terms:

Kidney Diseases

Kidney Failure, Chronic

Study Results

No Results Posted as of Jan 30, 2023