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Dietary Supplement
Carnitine Supplementation for Arterial Stiffness
Phase 2
Recruiting
Led By Justin P Zachariah, MD MPH
Research Sponsored by Baylor College of Medicine
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Fasting serum triglyceride levels over 130 and less than 500 mg/dL
Be younger than 65 years old
Must not have
Congenital heart disease requiring surgical or catheterization intervention
Known metabolic disorders that require carnitine therapy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 month
Summary
This trial will study whether taking a protein supplement called carnitine can help prevent heart disease by reducing arterial stiffness.
Who is the study for?
This trial is for boys and girls aged 11-21 with high triglyceride levels, but not too high cholesterol or any severe health issues like kidney failure, diabetes, heart disease, seizures, or pregnancy. They should be willing to follow the study rules.
What is being tested?
The study tests if a protein supplement called carnitine can prevent hardening of blood vessels in at-risk teens. Participants are randomly chosen to receive carnitine or not and researchers will also look at their genes related to carnitine.
What are the potential side effects?
Potential side effects aren't specified here but generally supplements like carnitine could cause digestive upset, fishy body odor, muscle weakness in people with low thyroid function (hypothyroidism), increased seizure risk in those who already have seizures.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My fasting triglyceride levels are between 130 and 500 mg/dL.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have a heart condition from birth that needed surgery or a catheter procedure.
Select...
I need carnitine therapy for my metabolic disorder.
Select...
I am on dialysis or have had a kidney transplant due to renal failure.
Select...
I have diabetes (type 1 or 2).
Select...
I have a known seizure disorder.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 6 month
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 month
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Change in Carotid Femoral Pulse Wave Velocity
Secondary study objectives
Change in Fasting Triglyceride
Change in Insulin Resistance
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Carnitine supplementation (CS+)Experimental Treatment1 Intervention
Carnitine supplementation in liquid form, sugar free.
Group II: Placebo (CS-)Placebo Group1 Intervention
Placebo comparator liquid similar in appearance and taste to CS+.
Find a Location
Who is running the clinical trial?
Baylor College of MedicineLead Sponsor
1,028 Previous Clinical Trials
6,030,072 Total Patients Enrolled
National Heart, Lung, and Blood Institute (NHLBI)NIH
3,944 Previous Clinical Trials
47,799,739 Total Patients Enrolled
Justin P Zachariah, MD MPHPrincipal InvestigatorStudy Principal Investigator
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My fasting triglyceride levels are between 130 and 500 mg/dL.I have a heart condition from birth that needed surgery or a catheter procedure.I am between 13 and 19 years old.I am between 11 and 21 years old.I need carnitine therapy for my metabolic disorder.I am on dialysis or have had a kidney transplant due to renal failure.I have diabetes (type 1 or 2).I am either male or female.I have a known seizure disorder.Your fasting LDL cholesterol level is less than 160 mg/dL.I am either male or female.This criterion does not exclude anyone based on their ethnicity or race.
Research Study Groups:
This trial has the following groups:- Group 1: Carnitine supplementation (CS+)
- Group 2: Placebo (CS-)
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Childhood Obesity Patient Testimony for trial: Trial Name: NCT04128969 — Phase 2