Omega-3 Supplementation for Smell Dysfunction

Study Overview
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Brief Summary
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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.

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

Conditions
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Sellar/Parasellar Tumor, Smell Dysfunction

Intervention / Treatment
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* Dietary Supplement: Omega-3


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Omega-3 Supplementation Group<br>Omega-3 supplementation | Dietary Supplement: Omega-3<br>* 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.<br>|
| No Intervention: Control Group<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difference in Olfactory Function at baseline, based upon tumor type (i.e. functional vs. non-functional tumor) | 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. | Baseline (pre-tumor resection) | 
| Change in Olfactory Function over 6-month post-op period | 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. | Baseline (pre-tumor resection), at 6 months (post-tumor resection) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Endoscopic Sellar/Parasellar Tumor Resection