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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
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
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 moreSide effects data
From 2021 Phase 2 & 3 trial • 144 Patients • NCT0178304125%
Patent ductus arteriosus
19%
Bronchopulmonary Dysplasia
6%
Blood culture positive sepsis
4%
Intraventricular hemorrhage
100%
80%
60%
40%
20%
0%
Study treatment Arm
5% Dextrose
L-carnitine
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
Find a Location
Who is running the clinical trial?
Vanderbilt University Medical CenterLead Sponsor
869 Previous Clinical Trials
678,614 Total Patients Enrolled
Anna R HemnesPrincipal InvestigatorVanderbilt University Medical Center
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