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: October 16, 2012
Last verified: October 2012

June 4, 2009
October 16, 2012
July 2009
September 2012   (final data collection date for primary outcome measure)
Change in Triglyceride level [ Time Frame: after 8 week treatment period ] [ Designated as safety issue: No ]
Efficacy (Triglyceride level change) [ Time Frame: after 8 week treatment period ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00915902 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Fish Oil Study for High Triglyceride Levels in Children
Fish Oil Treatment for Dyslipidemia Associated With Children and Adolescents

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.

Not Provided
Interventional
Phase 2
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Hypertriglyceridemia
  • Drug: Omega-3-acid ethyl esters
    Omega-3-acid ethyl esters (Lovaza) two 1-gram capsules taken twice daily
    Other Name: Lovaza
  • Drug: Placebo
    Placebo, two 1-gram capsules taken twice daily for 8 weeks
  • Experimental: Omega-3-acid ethyl esters (Lovaza)
    Intervention: Drug: Omega-3-acid ethyl esters
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
42
September 2012
September 2012   (final data collection date for primary outcome measure)

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
Both
10 Years to 17 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00915902
GIDDING
No
Samuel Gidding, Nemours Children's Clinic
Samuel Gidding
  • GlaxoSmithKline
  • Johns Hopkins University
  • Thomas Jefferson University
Principal Investigator: Samuel Gidding, MD Nemours
Nemours Children's Clinic
October 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP