Omega-3 Replacement With Krill Oil in Disease Management of SLE (ORKIDS)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03626311|
Recruitment Status : Not yet recruiting
First Posted : August 13, 2018
Last Update Posted : August 13, 2018
|Condition or disease||Intervention/treatment||Phase|
|Systemic Lupus Erythematosus (SLE)||Dietary Supplement: AKBM-3031 Other: Placebo||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||76 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Eligible patients will be randomized (1:1) to receive either AKBM-3031 or placebo during the randomized period.The randomized subjects will take (4)1 gram capsules of product or placebo every day, (2) 1 gram capsules in the morning and (2) 1 gram capsules in the evening, for a total of 4 grams per day for the first 24 weeks (randomized period). All subjects may continue to a 24-week extension (Open Label Extension) of open-label AKBM-3031, 4 grams/day. The total study duration per subject is 48 weeks. With about 4 months for site activation and 12 months for enrollment, the entire study is expected to complete in approximately 116 weeks.|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Primary Purpose:||Supportive Care|
|Official Title:||A Double-Blind, Placebo-Controlled Randomized, Multicenter Study to Assess Changes in Omega-3 Index in Erythrocytes and Health Benefit After 24 Weeks of Daily Consumption of AKBM-3031 (Omega-3 Phospholipids From Krill), Followed by a 24 Week Open-Label Extension, in Patients With Systemic Lupus Erythematosus (SLE)|
|Estimated Study Start Date :||August 2018|
|Estimated Primary Completion Date :||April 2020|
|Estimated Study Completion Date :||December 2020|
4g/day (2 capsules BID)
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 Name: Krill Oil
Placebo Comparator: Placebo
4g/day (2 capsules BID)
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.
- Difference in the ratio of omega-3 to omega-6 measured through lab tests on red blood cells from baseline through the end of the study in patients with generalized lupus. [ Time Frame: Baseline to 24 weeks ]
- Effect of correction of omega-3 deficiency measured by SLE biomarkers of immune function. [ Time Frame: Baseline to 24 weeks ]
- Effect of correction of omega-3 deficiency measured by both clinician and patient reported outcomes collected at clinic visits. [ Time Frame: Baseline to 24 weeks ]
- Change in health related quality of life measured using the Medical Outcomes study Short Form 36 (SF-36). [ Time Frame: Baseline to 24 weeks ]Both physical component scores (PCS) and mental component scores (MCS) will be assessed. Change in both PCS and MCS will be evaluated over the time of this study. The SF-36 is a patient recorded survey of health related quality of life, consisting of the evaluation of 8 domains, and then scored from 0-100. The higher score correlates to better health-related quality of life. The mean for healthy individuals is 50.
- Difference of number of patients with reported adverse events or changes in lab parameters while taking AKBM-3031. [ Time Frame: Baseline to 24 weeks ]Examples of patient reported adverse events include gastrointestinal symptoms, infection, unexplained bleeding, etc. Examples of lab parameters indicating an adverse event are changes in liver function tests, urinalysis, and hematologic parameters (which could be considered an adverse event).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03626311
|Contact: Audrey Ogendi, MPHemail@example.com|
|Contact: Debbie Scott||434-977-2675||Debbie.Scott@ampelbiosolutions.com|