Omega-3 Supplementation for Smell Dysfunction

Smell Dysfunction Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02529332
• Other study ID #: IRB00076285
• Status: Completed
• Phase: N/A
• Start date: September 2014
• Est. completion date: April 2018

Study information

• Verified date: August 2018
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 110
• Est. completion date: April 2018
• Est. primary completion date: April 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Sellar/Parasellar Tumor
• Smell Dysfunction

Intervention

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.

Locations

Country	Name	City	State
United States	Emory University Hospital	Atlanta	Georgia
United States	Stanford University	Stanford	California

Sponsors (2)

Lead Sponsor	Collaborator
Stanford University	Emory University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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)