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Amino Acid Supplementation

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

Q: How many people are being recruited for participation in this research program?

<p>Affirmative. Clinicaltrials.gov has information demonstrating that this medical trial began recruiting participants on April 1st 2021 and is currently looking for 48 volunteers from one site. The data was last updated on March 11th 2022.</p>

Q: Is there still space available for prospective participants in this research?

<p>Confirmed. According to clinicaltrials.gov, this research is still searching for patients - it was posted on April 1st 2021 and last updated March 11th 2022. The trial requires 48 individuals across one site.</p>

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline and day 90

Awards & highlights

Study 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.Check my eligibility

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.See study design

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.

Select...

I have ALD and my COVID-19 pneumonia diagnosis meets WHO criteria.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline and day 90

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline and day 90

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline and day 90 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in skeletal muscle mass at Day 0 and Day 90

Number of hospital admissions between Day 0 and Day 90

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.

0 / 6Eligibility criteria met

Find a Location

Who is running the clinical trial?

The Cleveland ClinicLead Sponsor

1,029 Previous Clinical Trials

1,365,030 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many people are being recruited for participation in this research program?

"Affirmative. Clinicaltrials.gov has information demonstrating that this medical trial began recruiting participants on April 1st 2021 and is currently looking for 48 volunteers from one site. The data was last updated on March 11th 2022."

Answered by AI

Is there still space available for prospective participants in this research?

"Confirmed. According to clinicaltrials.gov, this research is still searching for patients - it was posted on April 1st 2021 and last updated March 11th 2022. The trial requires 48 individuals across one site."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Study of HMB-enriched Amino Acid Supplementation in Patients With Alcoholic Liver Disease and COVID-19

Srinivasan Dasarathy 2021. "Study of HMB-enriched Amino Acid Supplementation in Patients With Alcoholic Liver Disease and COVID-19". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04858412.

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