Carnitine Supplementation for Arterial Stiffness
Trial Summary
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. However, if you have a known metabolic disorder that requires carnitine therapy, you cannot participate in the trial.
What data supports the effectiveness of the drug for arterial stiffness?
Research suggests that L-carnitine supplementation may improve walking performance in peripheral arterial disease, and low levels of L-carnitine are linked to increased arterial stiffness in patients who have had a kidney transplant. This indicates that L-carnitine might help reduce arterial stiffness.12345
Is carnitine supplementation safe for humans?
Research on carnitine supplements, including L-carnitine and levocarnitine, has been conducted in various conditions like cardiovascular diseases and hemodialysis. These studies generally suggest that carnitine is safe for human use, although specific safety data for arterial stiffness is not detailed.16789
How is the drug L-Carnitine unique in treating arterial stiffness?
What is the purpose of this trial?
Hardening of the blood vessels, called arterial stiffness, is a risk factor for future heart disease and its causes are unclear. The proposed study will 1) randomly assign adolescents at high risk of stiffening blood vessels to take a protein supplement called carnitine and study its effects on arterial stiffening and 2) study carnitine related genes for their effect on arterial stiffening. The study will definitively establish a role for carnitine action as a cause of stiffening blood vessels and signal a way to treat or prevent stiffening.
Research Team
Justin P Zachariah, MD MPH
Principal Investigator
Study Principal Investigator
Eligibility Criteria
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.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive 6 months of oral carnitine supplementation or placebo to study its effects on arterial stiffness
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- CS-
- CS+
CS- is already approved in United States, European Union, Canada, Japan for the following indications:
- Dietary supplement for heart health and energy production
- Treatment of carnitine deficiency, adjunctive therapy for the treatment of angina pectoris
- Dietary supplement for heart health and energy production
- Treatment of carnitine deficiency
Find a Clinic Near You
Who Is Running the Clinical Trial?
Baylor College of Medicine
Lead Sponsor
National Heart, Lung, and Blood Institute (NHLBI)
Collaborator