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Amino Acid Supplementation

HMB-Enriched Supplement for Alcoholic Liver Disease and COVID-19

N/A
Recruiting
Led By Srinivasan Dasarathy, MD
Research Sponsored by The Cleveland Clinic
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Cases: Patients with ALD and COVID-19 pneumonia must have Child Pugh score 5-8, serum creatinine <3, and Model for End Stage Liver Disease score (MELD) <25
Controls: Patients without alcoholic liver disease (Non-ALD) and COVID-19 pneumonia must be 21 years or older
Must not have
Patients on medications that alter muscle protein metabolism except systemic corticosteroids
Patients with advanced organ diseases: congestive heart failure (NYHA class 3 and 4), chronic obstructive pulmonary diseases (COPD) (GOLD stage 3 and 4), chronic kidney disease (Cr>3), metastatic malignancy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years

Summary

This trial will study whether HMB can help patients with comorbidities including ALD who have COVID-19 and are at risk for severe illness.

Who is the study for?
This trial is for adults over 21 with alcoholic liver disease (ALD) and COVID-19 pneumonia, who have a moderate level of liver impairment but not severe kidney issues or advanced organ diseases. They shouldn't be on certain muscle-affecting meds or blood thinners if in the biopsy group, need ventilator support, be pregnant, or have had recent gastrointestinal bleeding.
What is being tested?
The study tests whether an HMB-enriched amino acid supplement can help prevent severe illness and improve recovery in patients with ALD affected by COVID-19. It looks at how this condition progresses naturally and if HMB affects breathing problems and overall health outcomes.
What are the potential side effects?
While specific side effects are not listed here, supplements like HMB could potentially cause digestive discomfort, changes in blood sugar levels, muscle pain or cramps. However, these would vary based on individual health conditions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have ALD and COVID-19 pneumonia with moderate liver disease.
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I am over 21 and do not have alcoholic liver disease but have COVID-19 pneumonia.
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I am over 21 and have ALD with COVID-19 pneumonia.
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I have COVID-19 pneumonia but do not have alcoholic liver disease.
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I have alcoholic liver disease and COVID-19 pneumonia, diagnosed through tests or imaging.
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I have ALD and my COVID-19 pneumonia diagnosis meets WHO criteria.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am not on medication that changes muscle protein, except for corticosteroids.
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I do not have severe heart, lung, kidney diseases, or widespread cancer.
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I am willing and able to sign the informed consent.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Trial Design

2Treatment groups
Active Control
Placebo Group
Group I: HMB enriched amino acid armActive Control1 Intervention
The patients randomized to the HMB enriched amino acid (HMB/EAA) arm will be given HMB/EAA for 90 days.
Group II: Balanced amino acid armPlacebo Group1 Intervention
The patients randomized to the Balanced amino acid (BAA) arm will be given BAA for 90 days.

Find a Location

Who is running the clinical trial?

The Cleveland ClinicLead Sponsor
1,057 Previous Clinical Trials
1,371,712 Total Patients Enrolled
Srinivasan Dasarathy, MDPrincipal Investigator - Staff
Cleveland Clinic Hospital
R.G. Kar Medical College (Medical School)
Metrohealth Medical Center (Residency)
2 Previous Clinical Trials
60 Total Patients Enrolled

Media Library

β-hydroxy β-methyl butyrate (HMB) enriched amino acid (Amino Acid Supplementation) Clinical Trial Eligibility Overview. Trial Name: NCT04858412 — N/A
Alcoholic Liver Disease Research Study Groups: HMB enriched amino acid arm, Balanced amino acid arm
Alcoholic Liver Disease Clinical Trial 2023: β-hydroxy β-methyl butyrate (HMB) enriched amino acid Highlights & Side Effects. Trial Name: NCT04858412 — N/A
β-hydroxy β-methyl butyrate (HMB) enriched amino acid (Amino Acid Supplementation) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04858412 — N/A
~17 spots leftby Dec 2026
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