Safety Study of a Vitamin E Supplement in Normal Volunteers and Those With Both Allergy and Asthma

Asthma Clinical Trial

Official title: Comparison of Gamma-tocopherol Supplementation in Allergic Asthmatics and Normal Volunteers

Status Completed

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Allocation: Non-Randomized, Endpoint Classification: Bio-availability Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Screening

Related Conditions & MeSH terms

• Asthma

• NCT number: NCT00386178
• Study type: Interventional
• Source: University of North Carolina, Chapel Hill
• Status: Completed
• Phase: Phase 1
• Start date: October 2006
• Completion date: June 2007