Trial Outcomes & Findings for Fish Oil Study for High Triglyceride Levels in Children (NCT NCT00915902)
NCT ID: NCT00915902
Last Updated: 2022-11-08
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE2/PHASE3
Target enrollment
42 participants
Primary outcome timeframe
after 8 week treatment or placebo period
Results posted on
2022-11-08
Participant Flow
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.
Patients completed a 4 week dietary run-in prior to randomization at visit 2.
Participant milestones
| Measure |
Lovaza Then Placebo
Omega-3-acid ethyl esters (Lovaza) two 1-gram capsules taken twice daily for 8 weeks, then 4 week washout, then Placebo for 8 weeks
|
Placebo Then Lovaza
Placebo for 8 weeks, then 4 week washout, then Omega-3-acid ethyl esters (Lovaza) two 1-gram capsules taken twice daily for 8 weeks
|
|---|---|---|
|
1st Treatment Period
STARTED
|
20
|
22
|
|
1st Treatment Period
COMPLETED
|
19
|
22
|
|
1st Treatment Period
NOT COMPLETED
|
1
|
0
|
|
Washout (4 Weeks)
STARTED
|
19
|
22
|
|
Washout (4 Weeks)
COMPLETED
|
19
|
21
|
|
Washout (4 Weeks)
NOT COMPLETED
|
0
|
1
|
|
2nd Treatment Period
STARTED
|
19
|
21
|
|
2nd Treatment Period
COMPLETED
|
19
|
20
|
|
2nd Treatment Period
NOT COMPLETED
|
0
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Fish Oil Study for High Triglyceride Levels in Children
Baseline characteristics by cohort
| Measure |
Treatment (Lovaza) Followed by Placebo
n=20 Participants
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)
n=22 Participants
Placebo, two 1-gram capsules (corn oil) taken twice daily for 8 weeks followed by treatment (Lovaza) for 8 weeks
|
Total
n=42 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
14 years
STANDARD_DEVIATION 0.4 • n=5 Participants
|
14.2 years
STANDARD_DEVIATION 0.5 • n=7 Participants
|
14.1 years
STANDARD_DEVIATION 0.5 • n=5 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
15 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
29 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
20 participants
n=5 Participants
|
22 participants
n=7 Participants
|
42 participants
n=5 Participants
|
|
Triglyceride (mg/dL
|
260 mg/dL
STANDARD_DEVIATION 22 • n=5 Participants
|
280 mg/dL
STANDARD_DEVIATION 25 • n=7 Participants
|
270 mg/dL
STANDARD_DEVIATION 24 • n=5 Participants
|
PRIMARY outcome
Timeframe: after 8 week treatment or placebo periodOutcome measures
| Measure |
Omega-3-acid Ethyl Esters (Lovaza)
n=39 Participants
Omega-3-acid ethyl esters: Omega-3-acid ethyl esters (Lovaza) two 1-gram capsules taken twice daily
|
Placebo
n=39 Participants
Placebo: Placebo, two 1-gram capsules taken twice daily for 8 weeks
|
|---|---|---|
|
Change in Triglyceride Level
|
-52 mg/dL
Standard Deviation 16
|
-16 mg/dL
Standard Deviation 15
|
Adverse Events
Treatment (Lovaza) Followed by Placebo, During Treatment
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Treatment (Lovaza) Followed by Placebo, During Placebo
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Placebo Followed by Treatment (Lovaza), During Placebo
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Placebo Followed by Treatment (Lovaza), During Treatment
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Treatment (Lovaza) Followed by Placebo, During Treatment
n=20 participants at risk
Omega-3-acid ethyl esters (Lovaza) two 1-gram capsules taken twice daily for 8 weeks followed by placebo for 8 weeks. Adverse events during 8 weeks of treatment before placebo.
|
Treatment (Lovaza) Followed by Placebo, During Placebo
n=20 participants at risk
Omega-3-acid ethyl esters (Lovaza) two 1-gram capsules taken twice daily for 8 weeks followed by placebo for 8 weeks. Adverse events during 8 weeks of placebo, after 8 weeks of treatment and 4 weeks of washout.
|
Placebo Followed by Treatment (Lovaza), During Placebo
n=22 participants at risk
Placebo, two 1-gram capsules (corn oil) taken twice daily for 8 weeks followed by 4 week washout then treatment (Lovaza) for 8 weeks. Adverse events during 8 week placebo, after 8 weeks of treatment with Lovaza and a 4 week washout.
|
Placebo Followed by Treatment (Lovaza), During Treatment
n=22 participants at risk
Placebo, two 1-gram capsules (corn oil) taken twice daily for 8 weeks followed by 4 week washout then treatment (Lovaza) for 8 weeks. Adverse events during 8 week Treatment with Lovaza that followed 8 weeks of placebo and a 4 week washout.
|
|---|---|---|---|---|
|
Psychiatric disorders
depression, worsening
|
0.00%
0/20 • During the 20 week duration of the clinical trial. Specifically, during the first 8 week treatment period, the subsequent 4 week washout period, and the following 8 week treatment period.
Adverse Events were only collected and reported during the clinical trial, not after the conclusion of the trial, or prior to its start.
|
0.00%
0/20 • During the 20 week duration of the clinical trial. Specifically, during the first 8 week treatment period, the subsequent 4 week washout period, and the following 8 week treatment period.
Adverse Events were only collected and reported during the clinical trial, not after the conclusion of the trial, or prior to its start.
|
0.00%
0/22 • During the 20 week duration of the clinical trial. Specifically, during the first 8 week treatment period, the subsequent 4 week washout period, and the following 8 week treatment period.
Adverse Events were only collected and reported during the clinical trial, not after the conclusion of the trial, or prior to its start.
|
4.5%
1/22 • During the 20 week duration of the clinical trial. Specifically, during the first 8 week treatment period, the subsequent 4 week washout period, and the following 8 week treatment period.
Adverse Events were only collected and reported during the clinical trial, not after the conclusion of the trial, or prior to its start.
|
Other adverse events
Adverse event data not reported
Additional Information
Research Coordinator
Nemours Alfred I. duPont Hospital for Children
Phone: 302-651-6686
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place