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| ID | Type | Description | Link |
|---|---|---|---|
| KL2TR002646 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Center for Advancing Translational Sciences (NCATS) | NIH |
| IIMS-UT Health San Antonio | UNKNOWN |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment group Valine then EEA | Experimental | Valine will be administered as two 4 gm packets administered on dialysis treatment day followed by a washout period and then EEA |
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| Treatment group EEA then Valine | Experimental | EAA will be administered as one 12.5 gm packet administered on dialysis treatment day followed by a washout and then Valine |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Valine | Drug | A medical food intended for use under medical supervision |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Handgrip strength test | Change in handgrip strength measured by a dynamometer in lbs | Baseline to 17 weeks |
| Trail Making Test (TMT) | Change in minutes to complete Trail Making Test (TMT) A and B |
| Measure | Description | Time Frame |
|---|---|---|
| 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)? | Baseline to 17 weeks |
| 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)? |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Subrata Debnath, PhD | Contact | 210-567-4700 | nath@uthscsa.edu |
| Name | Affiliation | Role |
|---|---|---|
| Subrata Debnath, PhD | The University of Texas Health Science Center at San Antonio | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The University of Texas Health Science Center at San Antonio | Recruiting | San Antonio | Texas | 78229 | United States |
This study will comply with the NIH Data Sharing Policy and Policy on the Dissemination of NIH-Funded Clinical Trial Information and the Clinical Trials Registration and Results Information Submission rule. As such, this trial will be registered at ClinicalTrials.gov, and results information from this trial will be submitted to ClinicalTrials.gov. In addition, every attempt will be made to publish results in peer-reviewed journals.
At study completion, once data is published in a peer review journal
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| ID | Term |
|---|---|
| D007676 | Kidney Failure, Chronic |
| D005221 | Fatigue |
| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
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| ID | Term |
|---|---|
| D014633 | Valine |
| ID | Term |
|---|---|
| D000597 | Amino Acids, Branched-Chain |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
| D000601 | Amino Acids, Essential |
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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.
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The intervention will be administered to the subjects by appropriately trained delegates.
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| EEA | Drug | A medical food intended for use under medical supervision |
|
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| Baseline to 17 weeks |
| Baseline to 17 weeks |
| Blood valine metabolite 3-hydroxyisobutyrate (3-HIB) | Change in 3-hydroxyisobutyrate (3-HIB) levels | Baseline to 17 weeks |
| Blood valine beta-amino-isobutyric acid (BAIBA) | Change in beta-amino-isobutyric acid (BAIBA) | Baseline to 17 weeks |
| D052776 |
| Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012816 | Signs and Symptoms |