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NCT02021513 · ClinicalTrials.gov registry record · Phase 2
Pilot Study - Effect of Omega-3 on Systemic Lupus Erythematosus
A Phase 2 study, sponsored by University of Texas Southwestern Medical Center.
- Completed
- Registry status
- Phase 2
- Development phase
- 50
- Enrollment target
NCT02021513: Completed Phase 2 study, sponsored by University of Texas Southwestern Medical Center.
NCT02021513 is a Phase 2 study that has completed, run by University of Texas Southwestern Medical Center. The registered enrollment target is 50 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (62% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02021513, a Phase 2 study, has completed, sponsored by University of Texas Southwestern Medical Center.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 50 participants
- Enrollment target
Study Summary
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.
Primary Outcome
Blood collection by venipuncture for serum assessment of metabolomic profile (fatty acids, markers of oxidative stress, markers of inflammation, markers of energy stores).
Interventions
- DIETARY_SUPPLEMENT Fish Oil
- DIETARY_SUPPLEMENT Olive Oil
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 50 participants |
| Start Date | 2012-01 |
| Est. Completion | 2013-06 |
| Phase | Phase 2 |
What the finished NCT02021513 record still lists
NCT02021513 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 50 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (62% lower).
The record links to 0 conditions, and to 2 interventions - of which Fish Oil is the first listed.
NCT02021513 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02021513 about?
NCT02021513 is a clinical study titled "Pilot Study - Effect of Omega-3 on Systemic Lupus Erythematosus". 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...
What is the current status of trial NCT02021513?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 50 participants. The study started on 2012-01. Estimated completion is 2013-06.
What interventions are being tested in trial NCT02021513?
The interventions under investigation include: Fish Oil (DIETARY_SUPPLEMENT), Olive Oil (DIETARY_SUPPLEMENT).
Who is sponsoring clinical trial NCT02021513?
This trial is sponsored by University of Texas Southwestern Medical Center, which has 837 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02021513's enrollment target sits among peer trials
50 1195th of 2000 higher than 740 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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