Pilot Study - Effect of Omega-3 on Systemic Lupus Erythematosus
Public ClinicalTrials.gov record NCT02021513. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This is a single blind placebo-controlled pilot study involving Systemic Lupus Erythematosus and lupus nephritis patients. We propose to recruit and consent SLE patients who will be randomized to either receive the study drug, an over the counter fish oil supplement, or a placebo that contains olive oil. They will have a baseline metabolomic profile (blood test), nutritional assessment, fatigue severity scale, quality of life assessment, and SELENA-SLEDAI lupus disease activity assessments completed at the time of study medication distribution. Once 6 months of either the study drug or placebo is completed, then pill counts, assessments of experience/adherence (including side-effects, adverse effects, complaints, and un-blinding), and repeat nutritional assessment, fatigue severity scale, SELENA-SLEDAI, and metabolomic profile will be assessed. The study duration for each patient will be 6 months from initiation of the study drug. It is hypothesized that patients receiving the fish oil supplement will have improvement in their metabolomic profile. Additionally it is hypothesized that patients receiving the fish oil supplement will have improvement in disease activity, fatigue, and quality of life assessments.
Study identification
- NCT ID
- NCT02021513
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 50 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years to 64 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Dec 31, 2011
- Primary completion
- May 31, 2013
- Completion
- May 31, 2013
- Last update posted
- Dec 26, 2013
2012 – 2013
United States locations
- U.S. sites
- 1
- U.S. states
- 1
- U.S. cities
- 1
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| UT Southwestern Medical Center | Dallas | Texas | 75390 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT02021513, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Dec 26, 2013 · Synced Sep 11, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT02021513 live on ClinicalTrials.gov.