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Intranasal Retinoic Acid Treatment for Patients With OlfactoryLOSS: A RANDOMIZED CONTROLLED TRIAL

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ClinicalTrials.gov Identifier: NCT03574701
Recruitment Status : Recruiting
First Posted : July 2, 2018
Last Update Posted : July 3, 2018
Sponsor:
Information provided by (Responsible Party):
Amin Javer, St. Paul's Hospital, Canada

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.


Condition or disease Intervention/treatment Phase
Olfactory Disorder Dietary Supplement: Vitamin A Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

The patients will be randomized into 3 groups using the sealed envelope method. Each patient will be his or her own control. There will be two possible scenarios resulting from randomization:

  • 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.
  • Group B: This study group will receive Vitamin A in addition to their standard of care. They will not receive olfactory retraining.
  • Group C: This study group will receive only standard of care .
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Intranasal Retinoic Acid Treatment for Patients With Olfactory Loss: A Randomized Controlled Trial
Actual Study Start Date : May 25, 2016
Estimated Primary Completion Date : December 25, 2021
Estimated Study Completion Date : December 25, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vitamin A

Arm Intervention/treatment
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.
Dietary Supplement: 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.
Other Name: Essential oils

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.
Dietary Supplement: 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.
Other Name: Essential oils

No Intervention: C: Standard of Care
Group C: This study group will receive only standard of care .



Primary Outcome Measures :
  1. Olfactory Tests. [ Time Frame: For each subject this test will take 30 minutes ]
    These tests will be performed by same blinded assessor using the "Sniffin sticks" kit described above. The test is divided into three subtests including tests for olfactory thresholds (using phenyl ethyl alcohol), odor discrimination, and odor identification (TDI). The sum of the three scores reliably indicates the degree of olfactory function.


Secondary Outcome Measures :
  1. Sinonasal Outcomes Test - 22 (SNOT-22) [ Time Frame: For each subject this test will take between 5-10 minutes. ]
    The SNOT-22 is a sinus-specific questionnaire that evaluates subjective symptoms for patients suffering from chronic rhinosinusitis. SNOT-22 is scored out of 110 (22 questions, up to 5-points each) has demonstrated internal consistency, reliability, discriminate and concurrent validity and responsiveness to change. Responses will be summated and considered as a continuous, numerical variable. Mean, median, standard deviation and inter-quartile range will be reported.

  2. Sinus Mucosal Inflammation - Philpott-Javer (PJ) and Modified Lund-Kennedy (MLK) Endoscopic Staging System (ESS) [ Time Frame: For each subject this test will take about 5 minutes. ]
    Sinonasal mucosal inflammation is an objective measure assessed endoscopically and graded on both the PJ and MLK ESS for CRS. This is a standard of care procedure at all clinic visits. Similar to the MLK ESS, the PJ ESS scores the sinus cavities as a collective based on endoscopic findings and the presence or absence of allergic mucin. Images and/or videos of all sinuses are captured at each visit and archived on the hospital network as a standard of care.

  3. Questionnaire of Olfactory Disorders [ Time Frame: For each subject this test will take about 10 minutes. ]
    The consists of 25 statements that were divided into three general domains: 17 negative statements (QOD-NS), two positive statements (QOD-PS), and six socially desired statements (QOD-SD). Negative statements give information about the degree patients suffer from olfactory impairment, whereas positive statements indicate how well patients cope with their olfactory deficit. Socially desired statements indicate the extent to which an individual's answers were credible, or whether the person was trying to create a certain impression by providing socially desirable responses. In addition there are also problem questions and questions regarding sense of smell on a visual analogue scale.



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Ages Eligible for Study:   19 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03574701


Contacts
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Contact: Amin Javer, MD 6048069926 sinusdoc@me.com
Contact: Sara Derikvand, PhD 6048069926 stpaulsinusresearch@gmail.com

Locations
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Canada, British Columbia
St Paul Hospital Recruiting
Vancouver, British Columbia, Canada, V6Z 1Y6
Contact: Sara Derikvand, PhD    6048069926    stpaulsinusresearch@gmail.com   
Principal Investigator: Amin R Javer, MD         
St Paul Sinus Centre Recruiting
Vancouver, British Columbia, Canada, V6Z 1Y6
Contact: Amin Javer, MD    6048069926    sinusdoc@me.com   
Contact: Sara Derikvand, PhD    6048069926    stpaulsinusresearch@gmail.com   
Sponsors and Collaborators
St. Paul's Hospital, Canada
Investigators
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Principal Investigator: Amin Javer, MD FRCSCFARS University of British Columbia

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Responsible Party: Amin Javer, Director, St. Paul's Sinus Centre, St. Paul's Hospital, Canada
ClinicalTrials.gov Identifier: NCT03574701     History of Changes
Other Study ID Numbers: H15-02095
First Posted: July 2, 2018    Key Record Dates
Last Update Posted: July 3, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Amin Javer, St. Paul's Hospital, Canada:
olfactory
Vitamin A
Olfactory training
CRS

Additional relevant MeSH terms:
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Vitamins
Vitamin A
Retinol palmitate
Tretinoin
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Anticarcinogenic Agents
Antineoplastic Agents
Keratolytic Agents
Dermatologic Agents