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Omega-3 Supplementation for Smell Dysfunction

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02529332
Enrollment
110
Registered
2015-08-20
Start date
2014-09-30
Completion date
2018-04-30
Last updated
2018-08-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sellar/Parasellar Tumor, Smell Dysfunction

Keywords

Endoscopic Sellar/Parasellar Tumor Resection

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.

Interventions

DIETARY_SUPPLEMENTOmega-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.

Sponsors

Emory University
CollaboratorOTHER
Stanford University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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

Design outcomes

Primary

MeasureTime frameDescription
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.
Change in Olfactory Function over 6-month post-op periodBaseline (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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026