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:
2025-12-25 @ 3:46 AM
Ignite Modification Date:
2025-12-25 @ 3:46 AM
NCT ID:
NCT00915902
Eligibility Criteria:
Inclusion Criteria:
* Male or female patients who are 10-17 years of age
* Fasting triglyceride level \>150 mg/dl and \< 750 mg/dl measured on 2 separate occasions.
* Ability to follow the study procedures and adhere to the diet counseling recommendations
* Written parental permission and assent are obtained prior to any research procedures
Exclusion Criteria:
* Bleeding disorders
* Diabetes mellitus (impaired glucose tolerance is not an exclusion)
* Uncontrolled hypothyroidism
* Liver disease
* Allergy to fish/shellfish
* Patients requiring chronic use of aspirin and non-steroidal anti-inflammatory agents
* Patients requiring lipid lowering agents
* LDL-Cholesterol levels \>160 mg/dl
* Current participation in another clinical study or within the previous 30 days
* Alcohol use
* Currently pregnant or planning to become pregnant during the course of this trial (confirmed by pregnancy testing)
* Any significant medical condition which the investigator believes would interfere with the patient's ability to safely participate in this trial
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
10 Years
Maximum Age:
17 Years
Study:
NCT00915902
Study Brief:
Protocol Section:
NCT00915902