Omega-3 Supplementation for Smell Dysfunction

• Sponsor: Stanford University (Other)
• Overall Status: Completed
• CT.gov ID: NCT02529332
• Collaborator: Emory University (Other)
• Enrollment: 110
• Locations: 2
• Arms: 2
• Actual Duration (Months): 43
• Patients Per Site: 55
• Patients Per Site Per Month: 1.3

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Sellar/Parasellar Tumor; Smell Dysfunction	Dietary Supplement: Omega-3	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 110 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Effect of Omega-3 Supplementation in Patients With Smell Dysfunction Following Endoscopic Pituitary Tumor Resection
• Actual Study Start Date: Sep 1, 2014
• Actual Primary Completion Date: Apr 1, 2018
• Actual Study Completion Date: Apr 1, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Omega-3 Supplementation Group Omega-3 supplementation	Dietary Supplement: Omega-3; 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.
No Intervention: Control Group

Outcome Measures

Primary Outcome Measures

1. 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.

2. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Stanford University	Stanford	California	United States	94305
2	Emory University Hospital	Atlanta	Georgia	United States	30322

Sponsors and Collaborators

• Stanford University
• Emory University

Investigators

• Principal Investigator: Zara M Patel, MD, Stanford University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Zara M. Patel, Assistant Professor, Stanford University
• ClinicalTrials.gov Identifier: NCT02529332
• Other Study ID Numbers: IRB00076285
• First Posted: Aug 20, 2015
• Last Update Posted: Aug 21, 2018
• Last Verified: Aug 1, 2018

• Keywords provided by Zara M. Patel, Assistant Professor, Stanford University: Endoscopic Sellar/Parasellar Tumor Resection
• Additional relevant MeSH terms: Olfaction Disorders

Study Results

No Results Posted as of Aug 21, 2018