Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 10:48 PM
Ignite Modification Date:
2025-12-24 @ 10:48 PM
NCT ID:
NCT04128969
Eligibility Criteria:
Inclusion Criteria:
1. 11-21 year old adolescents
2. males and females
3. all ethnicities and races
4. fasting serum triglyceride levels over 130 and less than 500 mg/dL
5. fasting low density lipoprotein cholesterol (LDL-C) less than 160mg/dL.
Exclusion Criteria:
1. known seizure disorder
2. renal failure patients requiring renal replacement therapy like dialysis or renal transplant
3. diabetes mellitus type 1 or 2
4. congenital heart disease requiring surgical or catheterization intervention
5. current pregnancy or planned pregnancy during the active study participation
6. incarceration/institutionalized/wards of the state
7. known metabolic disorders that require carnitine therapy
8. nonadherence to study protocol during run-in phase defined as possessing 25% more than the expected remainder of placebo supplement pro-rated to the day of assessment
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
11 Years
Maximum Age:
21 Years
Study:
NCT04128969
Study Brief:
Protocol Section:
NCT04128969