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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.

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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

FieldValue
Enrollment Target 25 participants
Start Date 2008-12
Est. Completion 2010-12
Phase Phase 1

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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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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