NCT02529332

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
110

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2014

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2014

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

August 7, 2015

Completed
13 days until next milestone

First Posted

Study publicly available on registry

August 20, 2015

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2018

Completed
Last Updated

August 21, 2018

Status Verified

August 1, 2018

Enrollment Period

3.6 years

First QC Date

August 7, 2015

Last Update Submit

August 19, 2018

Conditions

Sellar/Parasellar TumorSmell Dysfunction

Keywords

Endoscopic Sellar/Parasellar Tumor Resection

Outcome Measures

Primary Outcomes (2)

  • 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)

Study Arms (2)

Omega-3 Supplementation Group

EXPERIMENTAL

Omega-3 supplementation

Dietary Supplement: Omega-3

Control Group

NO INTERVENTION

Interventions

Omega-3DIETARY_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.

Omega-3 Supplementation Group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Stanford University

Stanford, California, 94305, United States

Location

Emory University Hospital

Atlanta, Georgia, 30322, United States

Location

MeSH Terms

Conditions

Olfaction Disorders

Interventions

Docosahexaenoic Acids

Condition Hierarchy (Ancestors)

Sensation DisordersNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Fatty Acids, Omega-3Dietary Fats, UnsaturatedDietary FatsFatsLipidsFatty Acids, UnsaturatedFatty AcidsFish OilsOils

Study Officials

  • Zara M Patel, MD

    Stanford University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

August 7, 2015

First Posted

August 20, 2015

Study Start

September 1, 2014

Primary Completion

April 1, 2018

Study Completion

April 1, 2018

Last Updated

August 21, 2018

Record last verified: 2018-08

Locations

US(2)