Omega-3 Supplementation for Smell Dysfunction

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.

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Key information

Conditions

Sellar/Parasellar Tumor Nervous System Diseases Neurologic Manifestations Olfaction Disorders Pathological Conditions, Signs and Symptoms Sensation Disorders Signs and Symptoms Smell Dysfunction

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Stanford University, Stanford, California, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

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

Treatment and study plan

Omega-3

Dietary Supplement

Nature Made Ultra Omega3 Fish Oil 1400mg softgels contains 1000mg of omega 3 per serving. Participants will be instructed to take twice daily for 6 months.

Primary outcomes

Difference in Olfactory Function at baseline, based upon tumor type (i.e. functional vs. non-functional tumor)

Time frame: 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.
Change in Olfactory Function over 6-month post-op period

Time frame: 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.

Sponsors and collaborators

Lead sponsor

Stanford University

Other

Collaborators

Emory University

Registry information

Official study title

Effect of Omega-3 Supplementation in Patients With Smell Dysfunction Following Endoscopic Pituitary Tumor Resection

Important dates

Study start: 2014
Primary completion: 2018
Study completion: 2018
First posted: Aug 20, 2015
Registry last updated: Aug 21, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed