Health TrialsbyHealthPanel

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

ConditionEnd Stage Renal Disease
Trial statusRecruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age18-64
SponsorThe University of Texas Health Science Center at San Antonio

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Male or Female

Age 18-64 years

Receiving 3 x weekly in clinic hemodialysis for at least 6 months

Disqualifiers

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

Trial design

Design model

Crossover

Treatments tested in this trial

  • Valine

    Drug

    A medical food intended for use under medical supervision

  • EEA

    Drug

    A medical food intended for use under medical supervision

Treatment groups

28 Participants
are divided into 2 treatment groups
Group A: Treatment group Valine then EEAExperimental treatment 2 interventions
Group B: Treatment group EEA then ValineExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

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.

Time frame
Baseline to 17 weeks

Secondary outcomes

1

Handgrip strength test

Change in handgrip strength measured by a dynamometer in lbs

Time frame
Baseline to 17 weeks
2

Trail Making Test (TMT)

Change in minutes to complete Trail Making Test (TMT) A and B

Time frame
Baseline to 17 weeks

Other outcomes

1

Dialysate level of amino acids

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
2

Plasma level of amino acids

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
3

Blood valine metabolite 3-hydroxyisobutyrate (3-HIB)

Change in 3-hydroxyisobutyrate (3-HIB) levels

Time frame
Baseline to 17 weeks
4

Blood valine beta-amino-isobutyric acid (BAIBA)

Change in beta-amino-isobutyric acid (BAIBA)

Time frame
Baseline to 17 weeks

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

The University of Texas Health Science Center at San Antonio

Lead sponsor

National Center for Advancing Translational Sciences (NCATS)

Collaborator

IIMS-UT Health San Antonio

Collaborator

Source ClinicalTrials.gov
Apply now