Ignite Creation Date:
2024-05-05 @ 5:06 PM
Last Modification Date:
2024-10-26 @ 9:28 AM
Study NCT ID:
NCT00386178
Status:
COMPLETED
Last Update Posted:
2010-12-21
First Post:
2006-10-06
Brief Title:
Safety Study of a Vitamin E Supplement in Normal Volunteers and Those With Both Allergy and Asthma
Sponsor:
University of North Carolina Chapel Hill
Organization:
University of North Carolina Chapel Hill
Study Overview
Official Title:
Comparison of Gamma-tocopherol Supplementation in Allergic Asthmatics and Normal Volunteers
Status:
COMPLETED
Status Verified Date:
2010-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
Detailed Description:
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None