Omega-3 Replacement With Krill Oil in Disease Management of SLE

NACompletedINTERVENTIONAL
Enrollment

76

Participants

Timeline

Start Date

October 23, 2018

Primary Completion Date

August 21, 2021

Study Completion Date

August 21, 2021

Conditions
Systemic Lupus Erythematosus (SLE)
Interventions
DIETARY_SUPPLEMENT

AKBM-3031

"Krill are shrimp-like small crustaceans (up to 6 cm) found in all the world's oceans, but mostly in the Arctic and Antarctic polar seas. Krill are rich in the long-chain omega-3 polyunsaturated fatty acids or LC-PUFAs eicosapentaenoic acid (EPA, C20:5n3) and docosahexaenoic acid (DHA, C22:6n3). The lipid pool of krill is composed of phospholipids and triglycerides and the LC-PUFAs are primarily in the phospholipid fraction.~The product is produced under food Good Manufacturing Practice (GMP) regulations and has status as GRAS or Generally Recognized As Safe. GRAS is defined by the US Food and Drug Administration (FDA) as a substance that is generally recognized, among qualified experts, to be safe under the conditions of its intended use."

OTHER

Placebo

The placebo will be provided in capsules looking exactly as the krill oil capsules and will contain a fatty acid mixture (olive oil, corn oil, palm oil and medium chain triglycerides) which has the same composition as the average European diet (26.0% C16:0, 4.6% C18:0, 35.8% C18:1n9, 16.7% C18:2n6, 2.1% C18:3n3, 0% C20:4n6 and 14.8% other compounds) and contains no EPA or DHA.

Trial Locations (19)

10021

Hospital for Special Surgery, New York

10461

Albert Einstein College of Medicine, The Bronx

11021

Northwell Health, Great Neck

11030

Feinstein Institute for Medical Research, Manhasset

14642

University of Rochester Medical Center, Rochester

21201

University of Maryland, Baltimore

27157

Wake Forest Baptist Health, Winston-Salem

33136

University of Miami, Miami

35249

University of Alabama at Birmingham, Birmingham

48109

University of Michigan Health System, Ann Arbor

55902

Mayo Clinic, Rochester

60612

Rush Medical Center, Chicago

90211

Wallace Rheumatic Studies Center, LLC, Beverly Hills

92868

UC Irvine Health, Orange

02115

Brigham and Women's Hospital, Boston

Unknown

Lupus Clinic-Mary Pack Arthritis Centre, Vancouver

McMaster University Medical Center, Hamilton

McGill University Health Centre-The Montreal General Hospital, Montreal

University of Laval, Québec

All Listed Sponsors
collaborator

Ampel BioSolutions, LLC

INDUSTRY

lead

Aker BioMarine Human Ingredients AS

INDUSTRY

NCT03626311 - Omega-3 Replacement With Krill Oil in Disease Management of SLE | Biotech Hunter | Biotech Hunter