Treatment of Rhinitis With Intranasal Vitamin E - Full Text View

Sponsored by:	Penn State University
Information provided by:	Penn State University
ClinicalTrials.gov Identifier:	NCT00281307

Purpose

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.

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

Drug Information available for: alpha-Tocopheryl acetate alpha-Tocopherol Vitamin E Tocopherols Tocotrienol

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Efficacy Study
Official Title:	DBPCR Clinical Trial for Treatment of Rhinitis With Intranasal Vitamin E

Further study details as provided by Penn State University:

Primary Outcome Measures:

Reduction in the Rhinitis/Sinusitis Treatment Outcome Questionnaire (ROQa) composite score at the end of the 4th week [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Reduction of severity score for each individual symptom [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
Reduction of severity score for the composite symptom score at weekly intervals during the 4-week study period [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
Reduction of severity score for the Sinonasal Outcome Test (SNOT-16) at the end of the study [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
Reduction of severity score for the Mini-RQLQ (Mini Rhinoconjunctivitis Quality of Life Questionnaire) at the end of the study [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment:	149
Study Start Date:	January 2006
Estimated Study Completion Date:	October 2008
Estimated Primary Completion Date:	March 2008 (Final data collection date for primary outcome measure)

Intervention Details:

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

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00281307

Locations

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

Sponsors and Collaborators

Penn State University

Investigators

Principal Investigator:

Soheil Chegini, MD

Penn State University

More Information

Additional Information:

The Human Subjects Protection Office (HSPO) This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Penn State University ( Soheil Chegini )
Study ID Numbers:	IRB 21786
Study First Received:	January 23, 2006
Last Updated:	February 3, 2009
ClinicalTrials.gov Identifier:	NCT00281307 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by Penn State University:

Rhinitis
Vitamin E
Intranasal

Study placed in the following topic categories:

Tocopherol acetate
Otorhinolaryngologic Diseases
Antioxidants
Rhinitis
Trace Elements
Alpha-Tocopherol
Tocopherols

Vitamin E
Respiratory Tract Diseases
Respiratory Tract Infections
Vitamins
Tocotrienols
Micronutrients

Additional relevant MeSH terms:

Tocopherol acetate
Otorhinolaryngologic Diseases
Antioxidants
Molecular Mechanisms of Pharmacological Action
Growth Substances
Physiological Effects of Drugs
Rhinitis
Protective Agents
Nose Diseases

Pharmacologic Actions
Alpha-Tocopherol
Tocopherols
Vitamin E
Respiratory Tract Diseases
Respiratory Tract Infections
Vitamins
Micronutrients

ClinicalTrials.gov processed this record on May 07, 2009