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
Results First Received: April 4, 2014  
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
Condition: Hypertriglyceridemia
Interventions: Drug: Omega-3-acid ethyl esters
Drug: Placebo

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Patients were recruited from Nemours Alfred I. duPont Hospital for Children, Johns Hopkins University and Thomas Jefferson University. Recruitment took place between July 2009 and December 2011.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Patients completed a 4 week dietary run-in prior to randomization at visit 2.

Reporting Groups
  Description
Treatment (Lovaza) Followed by Placebo Omega-3-acid ethyl esters (Lovaza) two 1-gram capsules taken twice daily for 8 weeks, 4-week washout, Placebo for 8 weeks
Placebo Followed by Treatment (Lovaza) Placebo, two 1-gram capsules (corn oil) taken twice daily for 8 weeks, 4-week washout, Treatment for 8 weeks

Participant Flow:   Overall Study
    Treatment (Lovaza) Followed by Placebo     Placebo Followed by Treatment (Lovaza)  
STARTED     20     22  
COMPLETED     19     20  
NOT COMPLETED     1     2  



  Baseline Characteristics
  Hide Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Treatment (Lovaza) Followed by Placebo Omega-3-acid ethyl esters (Lovaza) two 1-gram capsules taken twice daily for 8 weeks followed by placebo for 8 weeks
Placebo Followed by Treatment (Lovaza) Placebo, two 1-gram capsules (corn oil) taken twice daily for 8 weeks followed by treatment (Lovaza) for 8 weeks
Total Total of all reporting groups

Baseline Measures
    Treatment (Lovaza) Followed by Placebo     Placebo Followed by Treatment (Lovaza)     Total  
Number of Participants  
[units: participants]
  20     22     42  
Age  
[units: years]
Mean ± Standard Deviation
  14  ± 0.4     14.2  ± 0.5     14.1  ± 0.5  
Gender  
[units: participants]
     
Female     5     8     13  
Male     15     14     29  
Region of Enrollment  
[units: participants]
     
United States     20     22     42  
Triglyceride (mg/dL  
[units: mg/dL]
Mean ± Standard Deviation
  260  ± 22     280  ± 25     270  ± 24  



  Outcome Measures

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


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Intrinsic variability of triglycerides is large and may have confounded analyses; 4-week washout between treatment periods may have been too short; a reduction of triglycerides in the corn oil placebo group may have compromised the results.


  More Information
  Hide More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Dr. Samuel Gidding
Organization: Nemours Alfred I. duPont Hospital for Children
phone: 302-651-6607
e-mail: sgidding@nemours.org


No publications provided


Responsible Party: Samuel Gidding, 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