Fish Oil Study for High Triglyceride Levels in Children

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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 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 or disease	Intervention/treatment	Phase
Hypertriglyceridemia	Drug: Omega-3-acid ethyl esters; Drug: Placebo	Phase 2; Phase 3

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. 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.

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	42 participants
Allocation:	Randomized
Intervention Model:	Crossover Assignment
Masking:	Triple (Participant, Care Provider, Investigator)
Primary Purpose:	Treatment
Official Title:	Fish Oil Treatment for Dyslipidemia Associated With Children and Adolescents
Study Start Date :	July 2009
Actual Primary Completion Date :	September 2012
Actual Study Completion Date :	September 2012

Arms and Interventions

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Arm	Intervention/treatment
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).	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
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.	Drug: Placebo; Placebo (corn oil), two 1-gram capsules taken twice daily for 8 weeks; Other Name: Corn Oil

Outcome Measures

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Primary Outcome Measures :

1. Change in Triglyceride Level [ Time Frame: after 8 week treatment or placebo period ]

Eligibility Criteria

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Ages Eligible for Study:	10 Years to 17 Years (Child)
Sexes Eligible for Study:	All
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

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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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Additional Information:

Information about Lovaza (this study's experimental treatment) from it's manufacturer, GlaxoSmithKline 

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
First Posted:	June 8, 2009
Results First Posted:	May 7, 2014
Last Update Posted:	December 8, 2015
Last Verified:	November 2015

Additional relevant MeSH terms:

Hypertriglyceridemia; Hyperlipidemias; Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases