Ignite Creation Date:
2024-05-06 @ 2:21 AM
Last Modification Date:
2024-10-26 @ 11:17 AM
Study NCT ID:
NCT02021513
Status:
COMPLETED
Last Update Posted:
2013-12-27
First Post:
2013-12-13
Brief Title:
Pilot Study - Effect of Omega-3 on Systemic Lupus Erythematosus
Sponsor:
University of Texas Southwestern Medical Center
Organization:
University of Texas Southwestern Medical Center
Study Overview
Official Title:
Pilot Study - Effect of Omega-3 on Systemic Lupus Erythematosus
Status:
COMPLETED
Status Verified Date:
2013-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 experienceadherence 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
Detailed Description:
Supplementation with EPA and DHA could potentially reduce the inflammatory state of SLE patients This study is a single blind placebo-controlled pilot for SLE patients with 25 scheduled to receive omega-3 EPA 225gDHA 225g daily and 25 scheduled to receive placebo olive oil for 6 months Pre and post supplementation assessments will be made to determine if EPA and DHA levels increase and if the levels of lipid peroxidation products other cellular energy intermediates and inflammatory markers are affected by EPADHA Additionally lupus disease activity fatigue quality of life and diet will be assessed to determine if these parameters are related to the metabolome in SLE
Aim 1
- To determine if the metabolomic disturbances of lupus patients improve following supplementation with omega-3 fatty acids
Aim 2
To determine if lupus disease activity fatigue and quality of life improve and are related to the metabolomic profile changes
Aim 1
- To determine if the metabolomic disturbances of lupus patients improve following supplementation with omega-3 fatty acids
Aim 2
To determine if lupus disease activity fatigue and quality of life improve and are related to the metabolomic profile changes
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None