RECRUITING

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

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Conditions

End Stage Renal DiseaseFatigueEnd-stage kidney diseaseHemodialysis

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2024-10-18
Study Completion:2026-03
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05705414

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.

Ages Eligible for Study:18 Years to 64 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Male or Female
  2. 2. Age 18-64 years
  3. 3. Receiving 3 x weekly in clinic hemodialysis for at least 6 months
  1. 1. Hypersensitivity to amino acid(s) and/or any excipient
  2. 2. Clinical documentation of COVID-19
  3. 3. Concomitant intake of amino acids supplements
  4. 4. Current use or abuse of alcohol, marijuana, narcotic, or other substances
  5. 5. Heart failure receiving active management
  6. 6. Malignant cancer receiving anticancer therapy
  7. 7. Diagnosis of major depressive disorder receiving antidepressants
  8. 8. Diagnosis of chronic liver disease
  9. 9. Cerebrovascular disease with sequelae
  10. 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.

Contacts and Locations

Study Contact

Subrata Debnath, PhD
CONTACT
210-567-4700
nath@uthscsa.edu

Principal Investigator

Subrata Debnath, PhD
PRINCIPAL_INVESTIGATOR
University of Texas Health Science Center San Antonio

Study Locations (Sites)

The University of Texas Health Science Center at San Antonio
San Antonio, Texas, 78229
United States

Collaborators and Investigators

Sponsor: The University of Texas Health Science Center at San Antonio

  • Subrata Debnath, PhD, PRINCIPAL_INVESTIGATOR, 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 Registration Dates

Study Start Date2024-10-18
Study Completion Date2026-03

Study Record Updates

Study Start Date2024-10-18
Study Completion Date2026-03

Terms related to this study

Keywords Provided by Researchers

  • Fatigue
  • End-stage kidney disease
  • Hemodialysis

Additional Relevant MeSH Terms

  • End Stage Renal Disease