Clinical trial NCT00281307: Treatment of Rhinitis With Intranasal Vitamin E
Official title: DBPCR Clinical Trial for Treatment of Rhinitis With Intranasal Vitamin E
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Rhinitis
Keywords: Rhinitis
Vitamin E
Intranasal
Lead sponsor: Milton S. Hershey Medical Center
Sponsor class: OTHER
First posted: 2006-01-24
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Reduction in the Rhinitis/Sinusitis Treatment Outcome Questionnaire (ROQa) composite score at the end of the 4th week
timeFrame: 4 weeks
Secondary outcomes:
measure: Reduction of severity score for each individual symptom
timeFrame: 4 weeks
measure: Reduction of severity score for the composite symptom score at weekly intervals during the 4-week study period
timeFrame: 4 weeks
measure: Reduction of severity score for the Sinonasal Outcome Test (SNOT-16) at the end of the study
timeFrame: 4 weeks
measure: Reduction of severity score for the Mini-RQLQ (Mini Rhinoconjunctivitis Quality of Life Questionnaire) at the end of the study
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Hershey
country: United States
facility: Cathy Mende, CRNP
state: Pennsylvania
Study officials:
affiliation: Penn State University
name: Soheil Chegini, MD
role: PRINCIPAL_INVESTIGATOR
References: