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The Effects of Lipinova on Inflammatory and Proresolving Lipid Mediator Profiles After Orthopedic Surgery

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03434236
Recruitment Status : Unknown
Verified February 2018 by Mieke A. Soens, Brigham and Women's Hospital.
Recruitment status was:  Not yet recruiting
First Posted : February 15, 2018
Last Update Posted : February 15, 2018
Sponsor:
Information provided by (Responsible Party):
Mieke A. Soens, Brigham and Women's Hospital

Brief Summary:
The aim of this pilot study is to investigate whether pre-operative supplementation with an over the counter dietary supplement containing a fractionated marine lipid concentrate derived from anchovy and sardine oil, Lipinova® (Solutex), improves the inflammatory profile and proresolving capacity in patients undergoing total knee arthroplasty. In addition, the investigators will compare the ability of two different dosing regimens to maximize SPM (Specialized Proresolving Mediators) availability.

Condition or disease Intervention/treatment Phase
Inflammation Surgery Dietary Supplement: low dose Lipinova (30 mL daily) Dietary Supplement: Placebo Dietary Supplement: high dose Lipinova (60mL) Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Other
Official Title: The Effects of Dietary Supplementation With Lipinova on Inflammatory and Proresolving Lipid Mediator Profiles in Patients Undergoing Total Knee Arthroplasty
Estimated Study Start Date : March 15, 2018
Estimated Primary Completion Date : October 1, 2018
Estimated Study Completion Date : November 1, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Placebo Comparator: Placebo
Patients will be taking placebo twice daily for 5 days prior to surgery. The placebo has a similar taste and smell as the active supplement.
Dietary Supplement: Placebo
Placebo will have a similar appearance, smell and taste as the nutritional supplement

Experimental: low dose Lipinova (30mL)
Patients will take 15 mL Lipinova (a dietary supplement containing omega-3 PUFA's) twice daily for 5 days prior to surgery.
Dietary Supplement: low dose Lipinova (30 mL daily)
Lipinova is a nutritional supplement containing concentrated n-3 PUFA (EPA and DHA) and metabolites

Experimental: high dose Lipinova (60mL)
Patients will take 30mL of Lipinova (a dietary supplement containing omega-3 PUFA's) twice daily for 5 days prior to surgery.
Dietary Supplement: high dose Lipinova (60mL)
Lipinova is a nutritional supplement containing concentrated n-3 PUFA (EPA and DHA) and metabolites




Primary Outcome Measures :
  1. SPM signature profile/Resolution Index [ Time Frame: 6 months ]
    cumulative levels (in pg/mL) in plasma and serum for DHA-derived SPMs (D-series resolvins: RvD1, RvD2, RvD3, RvD4, RvD5, RvD6, 17R-RvD1 and 17R-RvD3), Protectins (PD1, 17R-PD1), Maresins (MaR1) + EPA-derived SPMs (E-series Resolvins (RvE1, RvE2 and RvE3) + n-3 DPA-derived SPM (RvD1 n-3 DPA, RvD2n-3 DPA and RvD5 n-3 DPA), Protectins (10S, 17S-diHDPA), Marins (MaR1 n-3 DPA) and AA-derived Lipoxins (LXA4, LXB4, 15-epi-LXA4 and 15-epi-LXB4). Cumulative levels (in pg/mL) will be compared before and after treatment with supplement/placebo and before and after surgery. Lipid mediator profiling will be done with LC-MSMS.



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Ages Eligible for Study:   40 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients scheduled to undergo total knee arthroplasty at Brigham and Women's Hospital

Exclusion Criteria:

  • current treatment with corticosteroids or NSAIDs
  • evidence of active infection
  • chronic liver disease
  • end stage renal disease (CKD-5)
  • chronic inflammatory disorders
  • recent major illness or surgery within 30 days
  • use of immunosuppressive medication
  • history of organ transplantation
  • pregnancy or plans to become pregnant, or lactating
  • allergies to fish or fish oil
  • coagulation disorders or thrombocytopenia (platelet < 150,000)

Information from the National Library of Medicine

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): NCT03434236


Contacts
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Contact: Mieke Soens, MD 617-732-8217 msoens@bwh.harvard.edu

Sponsors and Collaborators
Brigham and Women's Hospital
Investigators
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Principal Investigator: Mieke Soens, MD Brigham and Women's Hospital
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Responsible Party: Mieke A. Soens, MD Staff Anesthesiologist, Brigham and Women's Hospital
ClinicalTrials.gov Identifier: NCT03434236    
Other Study ID Numbers: 2018P000102/PHS
First Posted: February 15, 2018    Key Record Dates
Last Update Posted: February 15, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Mieke A. Soens, Brigham and Women's Hospital:
omega-3
specialized proresolving mediators
Additional relevant MeSH terms:
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Inflammation
Pathologic Processes