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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: November 4, 2015
Last verified: November 2015

June 4, 2009
November 4, 2015
July 2009
September 2012   (final data collection date for primary outcome measure)
Change in Triglyceride Level [ Time Frame: after 8 week treatment or placebo 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
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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.

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. Treatment interval was 8 weeks with a 4 week wash out, between the two treatment intervals. Lipid profile, lipoprotein particle distribution and size, glucose, insulin, high sensitivity C reactive protien (CRP), interleukin-6, fibrinogen, plasminogen activator inhibitor-1 (PAI-1), and thrombin generation were measured.

Patients were evaluated at 6 time points: Visit 1/baseline (week 0), Visit 2/randomization (week 4), Visit 3/after treatment 1 (week 12) , Visit 4/after wash out (week 16), Visit 5/after treatment 2 (week 24) and Visit 6/close out (week 28) . Patients were advised to maintain a stable diet and not alter baseline fish consumption . One participant took an oral contraceptive throughout the trial. Any fish oil supplements were discontinued. Advice on a heart healthy diet was provided. Blood pressure (right arm sitting with appropriate sized cuff, taken 3 times, last measurement used), height, and weight were measured at the beginning of the study, after the first wash out period, and close out. Participant phone contact was made during each treatment arm to assess diet stability. Fasting lipid profile was performed at every visit. Red blood cell fatty acid profile and secondary endpoints were performed at all visits except baseline.

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 for 8 weeks
    Other Name: Lovaza
  • Drug: Placebo
    Placebo (corn oil), two 1-gram capsules taken twice daily for 8 weeks
    Other Name: Corn Oil
  • Experimental: Omega-3-acid ethyl esters (Lovaza)
    This randomized, double-blind, placebo, crossover trial consisted of two 8-week treatment periods, separated by a 4-week washout. Eligible patients were randomized to receive either fish oil 4 g daily or corn oil placebo during the first 8-week treatment period; patients received the alternate treatment during the next treatment period. GlaxoSmithKline supplied the study drug and the placebo. The study drug, Omega-3-acid ethyl esters (Lovaza) was given to patients PO daily as two, 1 g capsules taken twice daily during the duration of their 8-week treatment period. The study drug contained minimally 1.5 g DHA (docosahexaenoic acid) and 1.86 g EPA (eicosapentaenoic acid).
    Intervention: Drug: Omega-3-acid ethyl esters
  • Placebo Comparator: Placebo
    This randomized, double-blind, placebo, crossover trial consisted of two 8-week treatment periods, separated by a 4-week washout. Eligible patients were randomized to receive either fish oil 4 g daily or corn oil placebo during the first 8-week treatment period; patients received the alternate treatment during the next treatment period. The corn oil placebo was given to patients PO daily as two, 1 g capsules taken twice daily during the duration of their 8-week non-treatment (placebo) period.
    Intervention: Drug: Placebo
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*   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   (Child)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00915902
GIDDING
No
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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
November 2015

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