Treatment of Rhinitis With Intranasal Vitamin E

NCT ID: NCT00281307

Last Updated: 2017-07-18

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-12-07
• Study Completion Date: 2007-09-01

Brief Summary

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.

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.

Conditions

Rhinitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Interventions

RRR-alpha-tocopherol 1,000 IU/mL

Intranasal application three times daily vs. placebo (inert excipient)

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Milton S. Hershey Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Soheil Chegini, MD

Role: PRINCIPAL_INVESTIGATOR

Penn State University

Locations

Cathy Mende, CRNP

Hershey, Pennsylvania, United States

Countries

United States

Related Links

http://www.hmc.psu.edu/irb

The Human Subjects Protection Office (HSPO)

Other Identifiers

IRB 21786

Identifier Type: -

Identifier Source: org_study_id