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Efficacy of Fish Oil in Lupus Patients

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00828178
First Posted: January 23, 2009
Last Update Posted: November 18, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Michelle Petri M.D.,MPH, Johns Hopkins University
Results First Submitted: September 17, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Systemic Lupus Erythematosus
Interventions: Drug: Omega-3
Device: flow-mediated dilation of the brachial artery
Other: corn starch

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
106 patients were consented and 87 were randomized. Patients were part of the Hopkins Lupus Cohort seen quarterly.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Some of patients were excluded before being randomized for several reasons including "change of mind by patient, became pregnant, diagnosed with breast ca". Therefore a total of 87 patients started the trial.

Reporting Groups
  Description
Fish Oil fish oil 3 g of Omega-3 (1.8 g eicosapentaenoic acid, 1.2 g docosahexaenoic acid ethyl esters) daily
Placebo Placebo (corn starch) once daily

Participant Flow:   Overall Study
    Fish Oil   Placebo
STARTED   42   45 [1] 
COMPLETED   42   43 [2] 
NOT COMPLETED   0   2 
[1] Eighty seven participants were randomized.
[2] Two patients did not complete the study.



  Baseline Characteristics
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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
Fish Oil 3 g of Omega-3 (1.8 g eicosapentaenoic acid, 1.2 g docosahexaenoic acid ethyl esters)
Placebo corn starch
Total Total of all reporting groups

Baseline Measures
   Fish Oil   Placebo   Total 
Overall Participants Analyzed 
[Units: Participants]
 42   45   87 
Age 
[Units: Participants]
     
<=18 years   0   0   0 
Between 18 and 65 years   42   45   87 
>=65 years   0   0   0 
Age 
[Units: Years]
Mean (Standard Deviation)
 48.9  (10.6)   45.5  (10.8)   47.2  (10.4) 
Gender 
[Units: Participants]
     
Female   41   39   80 
Male   1   6   7 
Region of Enrollment 
[Units: Participants]
     
United States   42   45   87 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Effect on Brachial Artery Flow Dilation by Omega-3 Versus Placebo.   [ Time Frame: 12 weeks ]

2.  Secondary:   Effect of Omega-3 Versus Placebo on Disease Activity in SLE.   [ Time Frame: pre-treatment(baseline) and post-treatment (after 12 weeks) ]

3.  Secondary:   Effect on Markers of Inflammation: ICAM and VCAM by Omega-3 Versus Placebo.   [ Time Frame: pre-treatment(baseline) and post-treatment (after 12 weeks) ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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
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  More Information
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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. Michelle Petri
Organization: Johns Hopkins University School of Medicine
phone: 410-955-9114
e-mail: mpetri@jhmi.edu


Publications of Results:

Responsible Party: Michelle Petri M.D.,MPH, Johns Hopkins University
ClinicalTrials.gov Identifier: NCT00828178     History of Changes
Other Study ID Numbers: NA_00023813
First Submitted: January 22, 2009
First Posted: January 23, 2009
Results First Submitted: September 17, 2013
Results First Posted: November 18, 2016
Last Update Posted: November 18, 2016