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
  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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: DBPCR Clinical Trial for Treatment of Rhinitis With Intranasal Vitamin E

Resource links provided by NLM:


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:
    Drug: RRR-alpha-tocopherol 1,000 IU/mL
    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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
No publications provided

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

Keywords provided by Penn State University:
Rhinitis
Vitamin E
Intranasal

Additional relevant MeSH terms:
Rhinitis
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Vitamins
Vitamin E
Alpha-Tocopherol
Tocopherols
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents

ClinicalTrials.gov processed this record on September 22, 2014