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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03574701
Other study ID # H15-02095
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date May 25, 2016
Est. completion date December 25, 2022

Study information

Verified date September 2019
Source St. Paul's Hospital, Canada
Contact Amin Javer, MD
Phone 6048069926
Email sinusdoc@me.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Description:

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Study Design


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
Canada St Paul Hospital Vancouver British Columbia
Canada St Paul Sinus Centre Vancouver British Columbia

Sponsors (1)

Lead Sponsor Collaborator
St. Paul's Hospital, Canada

Country where clinical trial is conducted

Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary Olfactory Tests. 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. For each subject this test will take 30 minutes
Secondary Sinonasal Outcomes Test - 22 (SNOT-22) 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. For each subject this test will take between 5-10 minutes.
Secondary Sinus Mucosal Inflammation - Philpott-Javer (PJ) and Modified Lund-Kennedy (MLK) Endoscopic Staging System (ESS) 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. For each subject this test will take about 5 minutes.
Secondary Questionnaire of Olfactory Disorders 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. For each subject this test will take about 10 minutes.
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