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| Sponsor: | University of North Carolina, Chapel Hill |
|---|---|
| Collaborator: |
National Center for Complementary and Alternative Medicine (NCCAM) |
| Information provided by: | University of North Carolina, Chapel Hill |
| ClinicalTrials.gov Identifier: | NCT00386178 |
Purpose
Gamma tocopherol (gt) is a naturally occurring form of vitamin E that is found in many foods, and is also commercially available as a vitamin supplement. The purpose of this Phase 1 research study is to see if two doses of gt, 600mg and 1200mg, are safe (do not cause gastrointestinal distress or other problems), and can cause changes in your blood levels of gt and other antioxidants. This study will also examine if there is a difference in response between asthmatic and non-asthmatic adults when taking the same dose of gt. Phase 1 research studies like this one are not intended to be a treatment, but are a scientific investigation.
| Condition | Intervention | Phase |
|---|---|---|
|
Asthma |
Drug: Vitamin E supplement rich in gamma tocopherol |
Phase I |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Bio-availability Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Screening |
| Official Title: | Comparison of Gamma-tocopherol Supplementation in Allergic Asthmatics and Normal Volunteers |
| Enrollment: | 16 |
| Study Start Date: | October 2006 |
| Study Completion Date: | June 2007 |
| Primary Completion Date: | June 2007 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
Vitamin E supplement rich in gamma tocopherol
|
Drug: Vitamin E supplement rich in gamma tocopherol
daily dose of Vitamin E supplement rich in gamma tocopherol
Other Name: Maxi-Gamma
|
This is designed as an open label study of the effect of 600 mg and 1200mg gamma tocopherol (gt), orally administered daily for 8 days, on serum antioxidant levels in asthmatics and healthy volunteers. Each course of gamma tocopherol will be followed by a 7-8 day wash out period and serum testing to ensure that blood levels are back to baseline prior to starting the next course. The gamma tocopherol will be obtained from Yasoo Health Inc and contains 623mg gt per 830 mg gelatin capsule.
Allergy skin testing to a battery of allergens common to the region will be performed to determine the state of atopy both prior to drug administration and after the 8 day course. Allergic volunteers will be asked to abstain from taking any antihistamines during the 3 days prior to the skin testing. Repeat allergy testing will not be performed on subjects unable to hold antihistamines for health reasons, or on non-allergic volunteers who demonstrate no response to baseline testing. Spirometry will be performed to determine the current level of lung function. Subjects will be asked to refrain from taking vitamin supplements, non-steroidal anti-inflammatory medications and other dietary supplements.
Eligibility| Ages Eligible for Study: | 18 Years to 50 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria: allergic asthmatic cohort
Inclusion Criteria- healthy volunteer cohort
Exclusion Criteria:
Contacts and Locations| United States, North Carolina | |
| Center for Environmental Medicine, Asthma and Lung Biology at the University of North Carolina | |
| Chapel Hill, North Carolina, United States, 27599-7310 | |
| Principal Investigator: | David B Peden, MD, MS | University of North Carolina at Chapel Hill, Dept of Pediatrics / Center for Environmental Medicine, Asthma and Lung Biology |
More Information
| Responsible Party: | David Peden, MD/Principal Investigator, UNC Center for Environmental Medicine |
| ClinicalTrials.gov Identifier: | NCT00386178 History of Changes |
| Other Study ID Numbers: | 05-2833 |
| Study First Received: | October 6, 2006 |
| Last Updated: | December 20, 2010 |
| Health Authority: | United States: Institutional Review Board |
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vitamin E gamma tocopherol moderate to severe asthma healthy subjects |
|
Asthma Bronchial Diseases Respiratory Tract Diseases Lung Diseases, Obstructive Lung Diseases Respiratory Hypersensitivity Hypersensitivity, Immediate Hypersensitivity Immune System Diseases Gamma-Tocopherol Vitamin E |
Alpha-Tocopherol Tocopherols Tocotrienols Vitamins Antioxidants Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Protective Agents Physiological Effects of Drugs Micronutrients Growth Substances |