Status:
COMPLETED
Fish Oil Study for High Triglyceride Levels in Children
Lead Sponsor:
Babu Balagopal
Collaborating Sponsors:
GlaxoSmithKline
Johns Hopkins University
Conditions:
Hypertriglyceridemia
Eligibility:
All Genders
10-17 years
Phase:
PHASE2
PHASE3
Brief Summary
High triglyceride levels are increasingly recognized in children, particularly those who are overweight. There are no studies of treatment of high triglycerides in children and adolescents. Fish oil i...
Detailed Description
Participants (n = 42, age 14 + 2 yrs) with hypertriglyceridemia and LDL cholesterol \< 160 mg/dl were enrolled in a randomized double blind cross over trial comparing 4 g fish oil daily with placebo. ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2012
Estimated Enrollment :
42 Patients enrolled
Trial Details
Trial ID
NCT00915902
Start Date
July 1 2009
End Date
September 1 2012
Last Update
November 8 2022
Active Locations (3)
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1
A. I. duPont Hospital for Children
Wilmington, Delaware, United States, 19803
2
Johns Hopkins Hospital
Baltimore, Maryland, United States, 21287
3
Thomas Jefferon University
Philadelphia, Pennsylvania, United States, 19107