Fish Oil Study for High Triglyceride Levels in Children

This study has been completed.
Sponsor:
Collaborators:
GlaxoSmithKline
Johns Hopkins University
Thomas Jefferson University
Information provided by (Responsible Party):
Samuel Gidding, Nemours Children's Clinic
ClinicalTrials.gov Identifier:
NCT00915902
First received: June 4, 2009
Last updated: April 4, 2014
Last verified: April 2014
  Purpose

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 is attractive because it is considered safe and effective for treating high triglycerides in adults and has been used safely for other purposes in children. The investigators will conduct a randomized study of Lovaza (the only prescription omega-3 fish oil medication) in 44 children and adolescents to study efficacy in lowering triglycerides, safety, and possible mechanisms of beneficial effects.


Condition Intervention Phase
Hypertriglyceridemia
Drug: Omega-3-acid ethyl esters
Drug: Placebo
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: Fish Oil Treatment for Dyslipidemia Associated With Children and Adolescents

Resource links provided by NLM:


Further study details as provided by Nemours Children's Clinic:

Primary Outcome Measures:
  • Change in Triglyceride Level [ Time Frame: after 8 week treatment or placebo period ] [ Designated as safety issue: No ]

Enrollment: 42
Study Start Date: July 2009
Study Completion Date: September 2012
Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Omega-3-acid ethyl esters (Lovaza) Drug: Omega-3-acid ethyl esters
Omega-3-acid ethyl esters (Lovaza) two 1-gram capsules taken twice daily
Other Name: Lovaza
Placebo Comparator: Placebo Drug: Placebo
Placebo, two 1-gram capsules taken twice daily for 8 weeks

  Eligibility

Ages Eligible for Study:   10 Years to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00915902

Locations
United States, Delaware
A. I. duPont Hospital for Children
Wilmington, Delaware, United States, 19803
United States, Maryland
Johns Hopkins Hospital
Baltimore, Maryland, United States, 21287
United States, Pennsylvania
Thomas Jefferon University
Philadelphia, Pennsylvania, United States, 19107
Sponsors and Collaborators
Samuel Gidding
GlaxoSmithKline
Johns Hopkins University
Thomas Jefferson University
Investigators
Principal Investigator: Samuel Gidding, MD Nemours
  More Information

No publications provided

Responsible Party: Samuel Gidding, Chief of Cardiology, Alfred I. duPont Hospital for Children, Nemours Children's Clinic
ClinicalTrials.gov Identifier: NCT00915902     History of Changes
Other Study ID Numbers: GIDDING
Study First Received: June 4, 2009
Results First Received: April 4, 2014
Last Updated: April 4, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Hypertriglyceridemia
Dyslipidemias
Hyperlipidemias
Lipid Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on October 21, 2014