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

Early Phase 1

Recruiting

• Conditions: End Stage Renal Disease
• Interventions: Drug: Valine; Drug: EEA

• Registration Number: NCT05705414
• Lead Sponsor: The University of Texas Health Science Center at San Antonio

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.

Study Timeline

• Study First Submitted: 2023-01-21
• Study First Submitted QC: 2023-01-21
• Study First Posted: 2023-01-30
• Study Start: 2024-10-18
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-25
• Last Update Posted: 2024-11-28
• Primary Completion: 2025-12
• Study Completion: 2026-03

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 28

Inclusion Criteria

1. Male or Female
2. Age 18-64 years
3. Receiving 3 x weekly in clinic hemodialysis for at least 6 months

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Exclusion Criteria

1. Hypersensitivity to amino acid(s) and/or any excipient
2. Clinical documentation of COVID-19
3. Concomitant intake of amino acids supplements
4. Current use or abuse of alcohol, marijuana, narcotic, or other substances
5. Heart failure receiving active management
6. Malignant cancer receiving anticancer therapy
7. Diagnosis of major depressive disorder receiving antidepressants
8. Diagnosis of chronic liver disease
9. Cerebrovascular disease with sequelae
10. 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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Treatment group EEA then Valine	EEA	EAA will be administered as one 12.5 gm packet administered on dialysis treatment day followed by a washout and then Valine
Treatment group Valine then EEA	Valine	Valine will be administered as two 4 gm packets administered on dialysis treatment day followed by a washout period and then EEA
Treatment group Valine then EEA	EEA	Valine will be administered as two 4 gm packets administered on dialysis treatment day followed by a washout period and then EEA
Treatment group EEA then Valine	Valine	EAA will be administered as one 12.5 gm packet administered on dialysis treatment day followed by a washout and then Valine

Primary Outcome Measures

Name	Time	Method
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

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

Trial Locations

Locations (1)

The University of Texas Health Science Center at San Antonio; 🇺🇸 San Antonio, Texas, United States