Treatment of Rhinitis With Intranasal Vitamin E

July 13, 2017 updated by: Milton S. Hershey Medical Center

DBPCR Clinical Trial for Treatment of Rhinitis With Intranasal Vitamin E

Many beneficial effects of vitamin E have been described, but vitamin E supplementation by mouth has not been effective in the treatment of nasal symptoms and allergic rhinitis. The investigators will evaluate the effect of vitamin E directly applied to the lining of the nose in individuals with moderate to severe rhinitis by symptom questionnaires.

Study Overview

Status

Terminated

Conditions

Rhinitis

Intervention / Treatment

Drug: RRR-alpha-tocopherol 1,000 IU/mL

Detailed Description

Vitamin E has health promoting properties that are attributed to its anti-oxidant action and its ability to stabilize cell membrane and promote restoration of the skin barrier function. The beneficial effects of the topical vitamin E applied to the skin have been firmly established and many skin care products now contain vitamin E, whereas the purported benefits cannot be achieved by oral intake of vitamin E. Recently oral vitamin E was shown to be ineffective in the management of allergic rhinitis, which reminisces the clinical experience in dermatology. The failure of oral vitamin E could result from the relatively low local concentration that are not sufficient to scavenge the reactive oxygen species generated in the inflammatory process and restore the consequent epithelial damage to the nasal mucosa in rhinitis.The effect of topical vitamin E applied intranasally to the mucosa has never been studied. It stands to reason that higher local concentrations can be achieved by topical application of vitamin E directly to the nasal mucosa, which may confer the same positive effects observed with its direct application to the skin. We will perform a single center, prospective, randomized, double-blind, placebo-controlled, clinical trial to investigate the role of topical alpha-tocopherol in oil applied to the nasal mucosa 3 times per day with a q-tip on the subjective symptoms of rhinitis over the course of a 4-week period.

Study Type

Interventional

Enrollment (Actual)

Phase

Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

United States
- Pennsylvania
  - Hershey, Pennsylvania, United States, 17033
    - Cathy Mende, CRNP

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Description

Inclusion Criteria:

Clinical symptoms of rhinitis and symptom severity score of 25 or higher on the self-administered Rhinosinusitis Questionnaire (range of 0, i.e. absence of any symptom, to 50, which indicates the most severe symptom in each category)

Exclusion Criteria:

Inability to give informed consent, comprehend questions or instructions and complete questionnaires
Recent change (within 2 weeks) in the medications that may affect nasal or sinus symptoms (intranasal or systemic glucocorticosteroids, mast cell stabilizer, antihistamines, decongestants, leukotriene antagonist, antibiotics, preparations containing thyroid or sex hormones, alpha-blocking agents)
Intranasal use of oil- or gel-based products

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Interventional Model: Parallel Assignment
Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Reduction in the Rhinitis/Sinusitis Treatment Outcome Questionnaire (ROQa) composite score at the end of the 4th week Time Frame: 4 weeks	4 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
Reduction of severity score for each individual symptom Time Frame: 4 weeks	4 weeks
Reduction of severity score for the composite symptom score at weekly intervals during the 4-week study period Time Frame: 4 weeks	4 weeks
Reduction of severity score for the Sinonasal Outcome Test (SNOT-16) at the end of the study Time Frame: 4 weeks	4 weeks
Reduction of severity score for the Mini-RQLQ (Mini Rhinoconjunctivitis Quality of Life Questionnaire) at the end of the study Time Frame: 4 weeks	4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Milton S. Hershey Medical Center

Investigators

Principal Investigator: Soheil Chegini, MD, Penn State University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

The Human Subjects Protection Office (HSPO)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 7, 2005

Primary Completion (Actual)

September 1, 2007

Study Completion (Actual)