Ignite Creation Date:
2024-05-05 @ 4:39 PM
Last Modification Date:
2024-10-26 @ 9:22 AM
Study NCT ID:
NCT00281307
Status:
TERMINATED
Last Update Posted:
2017-07-18
First Post:
2006-01-23
Brief Title:
Treatment of Rhinitis With Intranasal Vitamin E
Sponsor:
Milton S Hershey Medical Center
Organization:
Milton S Hershey Medical Center
Study Overview
Official Title:
DBPCR Clinical Trial for Treatment of Rhinitis With Intranasal Vitamin E
Status:
TERMINATED
Status Verified Date:
2017-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
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
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 rhinitisThe 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None