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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 is a Phase 2 study that has completed, run by University of Texas Southwestern Medical Center. The registered enrollment target is 50 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02021513
The ClinicalTrials.gov registry entry for NCT02021513 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 50 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Texas Southwestern Medical Center, which has 837 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Fish Oil is the first listed.
NCT02021513 reports 0 study locations.
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.
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