Clinical Trial: Treatment of Rhinitis With Intranasal Vitamin E

Study Status: Suspended
Recruit Status: Suspended
Study Type: Interventional

Official Title: DBPCR Clinical Trial for Treatment of Rhinitis With Intranasal Vitamin E

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 Summary: 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.
Sponsor: Penn State University

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

Original Primary Outcome: Reduction in the Rhinitis/Sinusitis Treatment Outcome Questionnaire (ROQa) composite score at the end of the 4th week

Current Secondary Outcome:

  • Reduction of severity score for each individual symptom [ Time Frame: 4 weeks ]
  • Reduction of severity score for the composite symptom score at weekly intervals during the 4-week study period [ Time Frame: 4 weeks ]
  • Reduction of severity score for the Sinonasal Outcome Test (SNOT-16) at the end of the study [ Time Frame: 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 ]


Original Secondary Outcome:

  • 1. Reduction of severity score for each individual symptom
  • 2. Reduction of severity score for the composite symptom score at weekly intervals during the 4-week study period
  • 3. Reduction of severity score for the Sinonasal Outcome Test (SNOT-16) at the end of the study
  • 4. Reduction of severity score for the Mini-RQLQ (Mini Rhinoconjunctivitis Quality of Life Questionnaire) at the end of the study


Information By: Penn State University

Dates:
Date Received: January 23, 2006
Date Started: January 2006
Date Completion: October 2008
Last Updated: February 3, 2009
Last Verified: February 2009