Institutional Review Board, Hospital for Special Surgery
March 20, 2019
The safety of study participants is our top priority. The trial is approved and periodically reviewed by an Institutional Review Board (IRB), which includes doctors, administrators, ethicists, and members of the general public. The safety of clinical trials is reviewed by the U.S. Food and Drug Administration.
Before enrolling in a clinical trial, the investigator will explain the purpose of the trial, its expected benefits, any possible risks or side effects, and what your role will be. This is the time to ask questions! If you want to join the trial, you must sign the informed consent documents. You can leave a clinical trial at any time without penalty.
For further information, see Understanding Clinical Trials.
David R. Fernandez, MD, PhD
The main purpose of this research is to investigate whether treatment with Krill Phospholipids Concentrate (AKBM-3031), also known as Krill Oil, is able to replenish the omega-3 deficiency associated with Systemic Lupus Erythematosus (SLE). Omega-3 is an essential nutrient that is important in preventing and managing heart disease. In addition, this study is also being done to determine whether taking the Krill Oil has further positive effects in SLE patients with regards to slowing down the progression of and/or preventing disease flares. SLE is a disease that affects the immune system and can affect any part of the body (skin, joints, and/or organs).
Your participation in this research will last approximately 48 weeks. For the first 24 weeks of the study, eligible subjects will be randomly assigned in an equal ratio between either the placebo treatment group or the Krill Oil treatment group. These treatments will be taken in addition to your routine care and therapy. In the last 24 weeks of the study, all subjects will be placed on Krill Oil regardless of the treatment group they were previously assigned.
Study participation is voluntary. There will be a total of 8 clinic visits, including an eligibility screening visit, and 6 remote, phone visits. Each clinic visit will take approximately 2 hours and each phone visit approximately 10-25 minutes.
Someone CAN participate in this study if they meet the following:
Someone CANNOT participate in this study if they have the following: