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Amino Acid

L-carnitine for Lung Disease

Phase 1

Waitlist Available

Led By Anna R Hemnes

Research Sponsored by Vanderbilt University Medical Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 14 weeks

Awards & highlights

Study Summary

This trial is testing the hypothesis that carnitine supplementation can improve RV function in PAH patients by measuring the oral consumption of carnitine, the stability of plasma carnitine levels, and the effects of carnitine supplementation on RV function.

Eligible Conditions

Lung Disease
Pulmonary Arterial Hypertension
Pulmonary Hypertension
Carnitine Deficiency

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 14 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~14 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 14 weeks for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Plasma Carnitine concentration

Secondary outcome measures

Carnitine ingestion use through food

Echocardiography measurements of TAPSE and RV fractional area

Patient Reported Side Effects

+4 more

Side effects data

From 2021 Phase 2 & 3 trial • 144 Patients • NCT01783041

33%

Patent ductus arteriosus

32%

Bronchopulmonary Dysplasia

13%

Blood culture positive sepsis

Intraventricular hemorrhage

Surgical necrotizing entercolitis

100%

80%

60%

40%

20%

Study treatment Arm

L-carnitine

5% Dextrose

Trial Design

1Treatment groups

Experimental Treatment

Group I: SupplementExperimental Treatment1 Intervention

Form: 500 mg L-carnitine tablet Dosage: Subjects 50-90kg: 3g/day Subjects <50kg or >90kg: 50mg/kg/day Frequency: twice a day for 2 weeks

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

L-carnitine

2002

Completed Phase 4

~930

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Vanderbilt University Medical CenterLead Sponsor

858 Previous Clinical Trials

672,283 Total Patients Enrolled

Anna R HemnesPrincipal InvestigatorVanderbilt University Medical Center

Frequently Asked Questions

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

Has L-carnitine been granted authorization by the Food and Drug Administration?

"While data exists to suggest that L-carnitine is effective and safe, due to this being a Phase 1 trial we have given it the lowest possible rating of '1' on our scale."

Answered by AI

What is the upper bound on enrollment for this medical experiment?

"Affirmative. Clinicaltrials.gov's records demonstrate that this medical experiment, which went public on September 29th 2021 is actively asking for volunteers. A total of 12 individuals will be chosen from a single location for participation in the trial."

Answered by AI

Is there an age limit for individuals wishing to participate in the research trial?

"As stated in the study's eligibility requirements, individuals aged 18 to 85 are able to enroll."

Answered by AI

Are they admitting new participants in this experiment?

"As stated on clinicaltrials.gov, this medical experiment is currently recruiting participants. It was first made available on September 29th 2021 and the most recent modifications to it took place on August 30th 2022."

Answered by AI

Is it possible to enlist as a participant in this trial?

"This trial is seeking 12 volunteers who are aged 18 to 85, have a diagnosis of lung disease and meet some essential criteria. These include: (1) having been on a stable PAH-specific medication regime for 3 months; (2) no more than one adjustment in diuretics within the same time period; (3) IV prostacyclin readjustment permissible if side effects occur; (4) ambulatory ability and WHO Functional Class II-IV status."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Carnitine Consumption and Augmentation in Pulmonary Arterial Hypertension

Anna Hemnes 2021. "Carnitine Consumption and Augmentation in Pulmonary Arterial Hypertension". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04908397.