Fish Oil in Total Hip Replacement Randomized Clinical Trial
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|ClinicalTrials.gov Identifier: NCT04360239|
Recruitment Status : Not yet recruiting
First Posted : April 24, 2020
Last Update Posted : April 24, 2020
|Condition or disease||Intervention/treatment||Phase|
|Total Hip Arthroplasty||Dietary Supplement: Fish Oil||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||120 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Stopping Fish Oil Supplementation Prior to Total Hip Replacement a Randomized Clinical Trial|
|Estimated Study Start Date :||April 2020|
|Estimated Primary Completion Date :||March 2023|
|Estimated Study Completion Date :||December 2023|
Experimental: Fish Oil
Fish-Oil naïve subjects will be started on fish oil 4 weeks prior to surgery and continued until the 6 week follow up. Subjects already taking fish oil will be switched to the study fish-oil formulation of two capsules twice daily (3000 mg of EPA and DHA).
Dietary Supplement: Fish Oil
Fish-oil formulation of two capsules twice daily (3000 mg of EPA and DHA).
No Intervention: Control
No fish oil supplementation
- Total perioperative blood loss [ Time Frame: Post-operative day 5 ]Calculated total perioperative blood loss (mL) using Bourke's, Gross', Camarasa's, and Lopez-Picado's formula based on Post Operative Day 5 (POD5) Hemoglobin and Hematocrit
- Post-operative day 1 Hemoglobin [ Time Frame: Post-operative day 1 ]Post-operative day 1 Hemoglobin
- Post-operative day 1 Hematocrit [ Time Frame: Post-operative day 1 ]Post-operative day 1 Hematocrit
- Post-operative pain scores [ Time Frame: Post-operative day 1 pain scores will be determined for each patient using the visual analog scale ]Post-operative pain scores will be determined for each patient using a numeric rating scales (NRS) with 0 being no pain and 10 being worst pain possible.
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): NCT04360239
|Contact: Jeffrey D Stimac, MD||502-394-6341||Jeffrey.Stimac2@nortonhealthcare.org|
|Contact: Leah Carreon, MD||502.992.0488 ext 14139||Leah.Carreon@nortonhealthcare.org|
|Principal Investigator:||Jeffrey D Stimac, MD||Norton Healthcare|