Recruiting

Retinoic Acid

Sponsor:

St. Paul's Hospital, Canada

Code:

NCT03574701

Conditions

Olfactory Disorder

Eligibility Criteria

Sex: All

Age: 19 - 70+

Healthy Volunteers: Not accepted

Interventions

Vitamin A

Study Details

Brief summary:

About One to 2 percent of the North American population below the age of 65 years experience olfactory loss to a significant degree. It can result from advanced age, Post-infestious/inflammatory disorders, Obstructive disorders (e.g. nasal polyposis, tumors), posttraumatic (head trauma) and neurodegenerative disorders. Only a few studies have shown benefits of specific therapy for olfactory loss.

Vitamin has shown promise from both animal and human studies. However, none has studied the benefits of topical application of vitamin A. This study will be the first to examine this effect.

Conditions

Olfactory Disorder

Study ID

NCT03574701

Start date

May 25, 2016

Status verified date

Sep, 2019

Completion date

Dec 25, 2022

Anticipated

Primary completion date

Dec 25, 2021

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 19 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

Patients 19 years and above diagnosed with loss of olfactory function, (with or without history of sinonasal surgery) currently receiving sinonasal-related care at the St Paul's Sinus Centre.

Exclusion Criteria:

  • Patients with Primary anosmia.
  • Patients with baseline olfactory test scores >30 using Sniffin sticks test.
  • Patients with sinonasal tumors
  • Patients with polyps or significant inflammation blocking access of medication to the olfactory cleft.
  • Patients allergic to topical Vitamin A
  • Cystic fibrosis or syndromic patients
  • Patients with autoimmune diseases that have sinus manifestations or affect sinus function
  • Patients with previous history of hypervitaminosis A
  • Patients with Neurological Disease (e.g. stroke history, Parkinson's disease)
  • Patients who are pregnant

Study Design

Enrollment

120 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: A: Vitamin A and Olfactory Retraining

Group A: This study group will receive intranasal vitamin A at 10,000 I.U. per day and olfactory retraining using scented oils in addition to their standard of care.

experimental: B: Vitamin A

Group B: This study group will receive Vitamin A in addition to their standard of care. They will not receive olfactory retraining.

no intervention: C: Standard of Care

Group C: This study group will receive only standard of care .

Interventions

Vitamin A

The use of Vitamin A , in the treatment of olfactory loss has been previously studied in both animals and humans. These studies have shown promising results in the treatment of olfactory loss.

Primary outcome measure

  • Olfactory Tests. [ Time Frame: For each subject this test will take 30 minutes ]

Central Contacts and Locations

Central contacts

Amin Javer, MD

6048069926sinusdoc@me.com

Sara Derikvand, PhD

6048069926stpaulsinusresearch@gmail.com

Locations

St Paul Hospital

Recruiting

Vancouver, British Columbia, Canada, V6Z 1Y6

Contacts

Sara Derikvand, PhD

6048069926stpaulsinusresearch@gmail.com

Principal Investigator:

Amin R Javer, MD

St Paul Sinus Centre

Recruiting

Vancouver, British Columbia, Canada, V6Z 1Y6

Contacts

Amin Javer, MD

6048069926sinusdoc@me.com

Sara Derikvand, PhD

6048069926stpaulsinusresearch@gmail.com

More Information

Sponsor

St. Paul's Hospital, Canada

Last update posted

Sep 19, 2019

Last verified

Sep, 2019

Keywords

  • olfactory
  • Vitamin A
  • Olfactory training
  • CRS

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by St. Paul's Hospital, Canada on 2019-09-19.