Treatment of Rhinitis With Intranasal Vitamin E
| Tracking Information | |||||
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| First Received Date ICMJE | January 23, 2006 | ||||
| Last Updated Date | February 3, 2009 | ||||
| Start Date ICMJE | January 2006 | ||||
| Estimated Primary Completion Date | March 2008 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
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 ] | ||||
| Original Primary Outcome Measures ICMJE |
Reduction in the Rhinitis/Sinusitis Treatment Outcome Questionnaire (ROQa) composite score at the end of the 4th week | ||||
| Change History | Complete list of historical versions of study NCT00281307 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE |
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| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Treatment of Rhinitis With Intranasal Vitamin E | ||||
| Official Title ICMJE | 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. |
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| 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. |
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| Study Type ICMJE | Interventional | ||||
| Study Phase | Not Provided | ||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
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| Condition ICMJE | Rhinitis | ||||
| Intervention ICMJE | Drug: RRR-alpha-tocopherol 1,000 IU/mL
Intranasal application three times daily vs. placebo (inert excipient) |
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| Study Arm (s) | Not Provided | ||||
| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Suspended | ||||
| Estimated Enrollment ICMJE | 149 | ||||
| Estimated Completion Date | October 2008 | ||||
| Estimated Primary Completion Date | March 2008 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00281307 | ||||
| Other Study ID Numbers ICMJE | IRB 21786 | ||||
| Has Data Monitoring Committee | Not Provided | ||||
| Responsible Party | Soheil Chegini, Penn State University | ||||
| Study Sponsor ICMJE | Penn State University | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | Penn State University | ||||
| Verification Date | February 2009 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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