Treatment of Rhinitis With Intranasal Vitamin E

This study has suspended participant recruitment.
(Due to a substantial response to placebo an interim analysis indicated the need for a larger than expected study population to achieve the level of significance)
Sponsor:
Information provided by:
Penn State University
ClinicalTrials.gov Identifier:
NCT00281307
First received: January 23, 2006
Last updated: February 3, 2009
Last verified: February 2009

January 23, 2006
February 3, 2009
January 2006
March 2008   (final data collection date for primary outcome measure)
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 ]
Reduction in the Rhinitis/Sinusitis Treatment Outcome Questionnaire (ROQa) composite score at the end of the 4th week
Complete list of historical versions of study NCT00281307 on ClinicalTrials.gov Archive Site
  • 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 ]
  • 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
Not Provided
Not Provided
 
Treatment of Rhinitis With Intranasal Vitamin E
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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Rhinitis
Drug: RRR-alpha-tocopherol 1,000 IU/mL
Intranasal application three times daily vs. placebo (inert excipient)
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Suspended
149
October 2008
March 2008   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00281307
IRB 21786
Not Provided
Soheil Chegini, Penn State University
Penn State University
Not Provided
Principal Investigator: Soheil Chegini, MD Penn State University
Penn State University
February 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP