An interventional study of RRR-alpha-tocopherol 1,000 IU/mL in Rhinitis, sponsored by Milton S. Hershey Medical Center. Terminated at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-07-18.
Sponsored by Milton S. Hershey Medical Center · Not applicable, Interventional, and Treatment
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.
1,105 studies on the registry are indexed under Rhinitis; 65 are open to participants now.
This study's enrollment of 10 is below the median of 89 across 906 interventional studies indexed under Rhinitis.
Browse Rhinitis studies →Milton S. Hershey Medical Center is the lead sponsor of 480 studies on the registry; 61 are open to participants now.
Of its 56 completed or terminated interventional studies of FDA-regulated products, 42 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Intranasal application three times daily vs. placebo (inert excipient)
Reduction in the Rhinitis/Sinusitis Treatment Outcome Questionnaire (ROQa) composite score at the end of the 4th week
Time frame: 4 weeks
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
This study is terminated, as verified in Jul 2017. You cannot join it, but the record below documents what was studied.
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Milton S. Hershey Medical Center