Main
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
|
ClinicalTrials.gov |
Last refreshed on:
|
19 February 2015 |
Main ID: |
NCT02021513 |
Date of registration:
|
13/12/2013 |
Prospective Registration:
|
No |
Primary sponsor: |
|
Public title:
|
Pilot Study - Effect of Omega-3 on Systemic Lupus Erythematosus
|
Scientific title:
|
Pilot Study - Effect of Omega-3 on Systemic Lupus Erythematosus |
Date of first enrolment:
|
January 2012 |
Target sample size:
|
50 |
Recruitment status: |
Completed |
URL:
|
http://clinicaltrials.gov/show/NCT02021513 |
Study type:
|
Interventional |
Study design:
|
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
|
Phase:
|
Phase 2
|
|
Countries of recruitment
|
United States
| | | | | | | |
Contacts
|
Name:
|
Cristina G Arriens, MD |
Address:
|
|
Telephone:
|
|
Email:
|
|
Affiliation:
|
UT Southwestern Medical Center |
| | |
Key inclusion & exclusion criteria
|
Inclusion Criteria:
- Male or Female
- All ethnic groups
- Aged 18-64
- Biopsy proven diagnosis of Lupus Nephritis and/or fulfillment of 4 or more American
College of Rheumatology criteria for the diagnosis of Systemic Lupus Erythematosus
Exclusion Criteria:
- Currently taking, or have taken in the last 2 months, fish oil/omega-3 fatty
acid/DHA/EPA
- Allergic to fish oil, shellfish, or other fish products
- Pregnant
- Currently taking the medication: Tositumomab (Bexxar)
- Currently taking anti-coagulant medications (Abciximab, Acenocoumarol, Anisindione,
Ardeparin, Argatroban, Bivalirudin, Certoparin, Cilostazol, Clopidogrel, Dalteparin,
Danaparoid, Defibrotide, Dermatan Sulfate, Desirudin, Dicumarol, Enoxaparin,
Eptifibatide, Fondaparinux, Heparin, Lamifiban, Nadroparin, Phenindione,
Phenprocoumon, Reviparin, Sibrafiban, Tinzaparin,Tirofiban, Warfarin, Xemilofiban)
Age minimum:
18 Years
Age maximum:
64 Years
Gender:
Both
|
Health Condition(s) or Problem(s) studied
|
Systemic Lupus Erythematosus
|
Intervention(s)
|
Dietary Supplement: Fish Oil
|
Dietary Supplement: Olive Oil
|
Primary Outcome(s)
|
Metabolomic profile
[Time Frame: Change from baseline at 6 months]
|
Secondary Outcome(s)
|
Disease Activity
[Time Frame: Change from baseline at 6 months]
|
FSS
[Time Frame: Change from baseline at 6 months]
|
SF-36
[Time Frame: Change from baseline at 6 months]
|
Source(s) of Monetary Support
|
Please refer to primary and secondary sponsors
|
Results
|
Results available:
|
|
Date Posted:
|
|
Date Completed:
|
|
URL:
|
|
|
|