In Vitro Basophil Responsiveness to Allergen Challenge After Gamma-tocopherol Supplementation in Allergic Asthmatics
In Vitro Basophil Responsiveness to Allergen Challenge After Gamma-tocopherol Supplementation in Allergic Asthmatics
NCT ID: NCT00836368 Phase: PHASE1 Status: COMPLETED Enrollment: 25 Completion: 2010-12
Conditions
Allergic, Asthmatic, Allergy, Asthma
Interventions
gamma-tocopherol
Summary
Purpose: This is a non-masked study with a primary endpoint of in vitro basophil activation by the allergen D. farinae, comparing basophil activation before and after seven days of supplementation. Secondary endpoints will include circulating antioxidant levels (tocopherols and metabolites), in vitro basophil activation to IgG anti-IgE and to N-formyl-methionyl-leucyl-phenylalanine (f-met-leu-phe), and monocyte and basophil responsiveness to in vitro endotoxin challenge.
Participants: Twenty allergic asthmatic volunteers Procedures (methods): Volunteers will be given 1200 mg of a gamma tocopherol enriched supplement, a commercially available supplement form of vitamin E. Study participants will undergo assessment of general health, lung function assessment, symptom scoring, and epicutaneous skin test to allergens at baseline and after supplementation. Blood samples will be collected at baseline and after 7 days of gamma-T treatment.
Primary Outcome
We intend to examine the effect of once daily oral doses 1,200 mg of gamma tocopherol (2 capsules of the gamma tocopherol enriched vitamin E preparation) on in vitro basophil activation with D. farinae challenge.