[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT05705414":3,"trial-entities:NCT05705414":83,"trial-summary:NCT05705414":87},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":20,"study_type":24,"primary_purpose":25,"phases":26,"enrollment_info":28,"interventions":31,"primary_outcomes":46,"secondary_outcomes":51,"sex":58,"minimum_age":59,"maximum_age":60,"healthy_volunteers":15,"eligibility_criteria":61,"std_ages":65,"locations":67,"central_contacts":76,"overall_officials":77,"references":81,"see_also_links":82},"NCT05705414","HSC20220558H","Oral Intradialytic Amino Acid Supplementation to Vitalize End-stage Kidney Disease Patients on Hemodialysis","Oral Intradialytic Amino Acids Supplementation to Vitalize End-stage Kidney Disease Patients on Hemodialysis (OASIS)","COMPLETED","2026-05-30","2026-08","2026-08-26","2024-10-18","The University of Texas Health Science Center at San Antonio","OTHER",false,"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.","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.",[19],"End Stage Renal Disease",[21,22,23],"Fatigue","End-stage kidney disease","Hemodialysis","INTERVENTIONAL","TREATMENT",[27],"EARLY_PHASE1",{"count":29,"type":30},28,"ACTUAL",[32,41],{"type":33,"name":34,"description":35,"armGroupLabels":36,"otherNames":39},"DRUG","Valine","A medical food intended for use under medical supervision",[37,38],"Treatment group EEA then Valine","Treatment group Valine then EEA",[40],"Valine Amino Acid Supplement",{"type":33,"name":42,"description":35,"armGroupLabels":43,"otherNames":44},"EEA",[37,38],[45],"Essential Amino Acid Supplement",[47],{"measure":48,"description":49,"timeFrame":50},"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.","Baseline to 17 weeks",[52,55],{"measure":53,"description":54,"timeFrame":50},"Handgrip strength test","Change in handgrip strength measured by a dynamometer in lbs",{"measure":56,"description":57,"timeFrame":50},"Trail Making Test (TMT)","Change in minutes to complete Trail Making Test (TMT) A and B","ALL","18 Years","64 Years",{"inclusion":62,"exclusion":63,"raw_text":64},[],[],"Inclusion Criteria:\n\n1. Male or Female\n2. Age 18-64 years\n3. Receiving 3 x weekly in clinic hemodialysis for at least 6 months\n\nExclusion Criteria:\n\n1. Hypersensitivity to amino acid(s) and\u002For any excipient\n2. Clinical documentation of COVID-19\n3. Concomitant intake of amino acids supplements\n4. Current use or abuse of alcohol, marijuana, narcotic, or other substances\n5. Heart failure receiving active management\n6. Malignant cancer receiving anticancer therapy\n7. Diagnosis of major depressive disorder receiving antidepressants\n8. Diagnosis of chronic liver disease\n9. Cerebrovascular disease with sequelae\n10. 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.",[66],"ADULT",[68],{"facility":13,"city":69,"state":70,"zip":71,"country":72,"geoPoint":73},"San Antonio","Texas","78229","United States",{"lat":74,"lon":75},29.42412,-98.49363,[],[78],{"name":79,"affiliation":13,"role":80},"Subrata Debnath, PhD","PRINCIPAL_INVESTIGATOR",[],[],{"nct_id":4,"conditions":84,"biomarkers":86},[85],"Chronic Kidney Disease, Stage 5",[],{"nct_id":4,"found":88,"summary":89,"prompt_version":99},true,{"design":90,"status":91,"heading":92,"summary":93,"follow_up":94,"word_count":95,"commitments":96,"compensation":97,"drugs_mentioned":98},"This is a single-center study planning to enroll 28 participants. It will compare the effects of Valine with a combination of essential amino acids (EEA).","completed","Oral Amino Acid Supplementation for End-Stage Kidney Disease Patients on Hemodialysis","This study is looking for people aged 18-64 with end-stage kidney disease who are receiving hemodialysis three times a week. It aims to see if taking Valine or a combination of essential amino acids (EEA) can help improve fatigue, frailty, and thinking abilities. Both Valine and EEA are medical foods. The study will measure changes in your fatigue levels using a tool called the Brief Fatigue Inventory (BFI) over 17 weeks to see if the supplements are successful. We don't have information on the current recruitment status for this study.","Your fatigue levels will be measured from the beginning of the study up to 17 weeks.",90,"Not specified in the trial record.","Not stated in the trial record.",[34,42],"v2"]