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NCT00836368 · ClinicalTrials.gov registry record · Phase 1
In Vitro Basophil Responsiveness to Allergen Challenge After Gamma-tocopherol Supplementation in Allergic Asthmatics
A Phase 1 study of Asthma and Allergy, sponsored by University of North Carolina, Chapel Hill.
- Completed
- Registry status
- Phase 1
- Development phase
- 25
- Enrollment target
- 1
- Study location
NCT00836368 is a Phase 1 study of Asthma and Allergy that has completed, run by University of North Carolina, Chapel Hill. The registered enrollment target is 25 participants, below the 1,563-participant average among 374 other Asthma trials with a reported enrollment target (98% lower). The trial reports 1 study location across 1 state.
The verdict
NCT00836368, a Phase 1 study of Asthma and Allergy, has completed, sponsored by University of North Carolina, Chapel Hill.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 25 participants
- Enrollment target
- 1
- Study location
Study 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.
Interventions
- DIETARY_SUPPLEMENT gamma-tocopherol
Study Locations (1)
North Carolina
- Center for Environmental Medicine Asthma and Lung Biology - Chapel Hill
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 25 participants |
| Start Date | 2008-12 |
| Est. Completion | 2010-12 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00836368
The ClinicalTrials.gov registry entry for NCT00836368 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 25 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 1,563-participant average among 374 other Asthma trials with a reported enrollment target (98% lower). The listed sponsor is University of North Carolina, Chapel Hill, which has 1,109 total studies on file at ClinicalTrials.gov.
The record links to 4 conditions, with Asthma appearing as the primary indexed condition, and to 1 intervention - of which gamma-tocopherol is the first listed.
NCT00836368 reports 1 study location spanning 1 distinct geographic area - top geographies include North Carolina.
Frequently Asked Questions
What is clinical trial NCT00836368 about?
NCT00836368 is a clinical study titled "In Vitro Basophil Responsiveness to Allergen Challenge After Gamma-tocopherol Supplementation in Allergic Asthmatics". 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 vitr...
What is the current status of trial NCT00836368?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 25 participants. The study started on 2008-12. Estimated completion is 2010-12.
What conditions does trial NCT00836368 study?
This clinical trial studies the following conditions: Asthma, Allergy, Allergic, Asthmatic.
What interventions are being tested in trial NCT00836368?
The interventions under investigation include: gamma-tocopherol (DIETARY_SUPPLEMENT).
Who is sponsoring clinical trial NCT00836368?
This trial is sponsored by University of North Carolina, Chapel Hill, which has 1,109 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00836368 being conducted?
This trial has 1 study location across North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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