Omega-3 Supplementation for Smell Dysfunction

Not Applicable

Completed

• Conditions: Smell Dysfunction; Sellar/Parasellar Tumor
• Interventions: Dietary Supplement: Omega-3

• Registration Number: NCT02529332
• Lead Sponsor: Stanford University

Brief Summary

Omega-3 supplementation has been shown to have neuroprotective and potentially anti-inflammatory properties in both central and peripheral nerve injuries. The investigators are studying to see if omega-3 supplementation will affect olfactory (smell) function in patients with olfactory dysfunction following endoscopic removal of pituitary tumors.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-09
• Study First Submitted: 2015-08-07
• Study First Submitted QC: 2015-08-19
• Study First Posted: 2015-08-20
• Primary Completion: 2018-04
• Study Completion: 2018-04
• Status Verified: 2018-08
• Last Update Submitted: 2018-08-19
• Last Update Posted: 2018-08-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 110

Inclusion Criteria

• sellar/parasellar tumor scheduled to undergo endoscopic transnasal transsphenoidal resection
• 18 years of age or older
• English speaking

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Exclusion Criteria

• Currently using blood thinning agents (aside from NSAIDs or cardioprotective ASA)
• elevated AST, ALT, or alk phos >10% outside of normal range, if randomized to omega-3 group
• diabetes, if randomized to omega-3 group and not already on omega-3 prescribed by another provider
• unable to provide informed consent due cognitive deficiencies

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Omega-3 Supplementation Group	Omega-3	Omega-3 supplementation

Primary Outcome Measures

Name	Time	Method
Change in Olfactory Function over 6-month post-op period	Baseline (pre-tumor resection), at 6 months (post-tumor resection)	The University of Pennsylvania Smell Identification Test (UPSIT) will be used to determine baseline olfactory function prior to sellar/parasellar tumor resection for all subjects.The test consists of a total of 40 "scratch and sniff" strips which the individual must select the correct odor from four choices. The test is scored out of 40 items. The number of correct answers regarding the smells being experienced is the subject's score. The higher the score the better the sense of smell. A change in UPSIT scores of 10% or greater indicates a clinically significant improvement.
Difference in Olfactory Function at baseline, based upon tumor type (i.e. functional vs. non-functional tumor)	Baseline (pre-tumor resection)	The University of Pennsylvania Smell Identification Test (UPSIT) will be used to determine baseline olfactory function prior to sellar/parasellar tumor resection for all subjects.The test consists of a total of 40 "scratch and sniff" strips which the individual must select the correct odor from four choices. The test is scored out of 40 items. The number of correct answers regarding the smells being experienced is the subject's score. The higher the score the better the sense of smell.

Trial Locations

Locations (2)

Stanford University; 🇺🇸 Stanford, California, United States

Emory University Hospital; 🇺🇸 Atlanta, Georgia, United States