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

NCT00386178 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2010-12-21

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Vitamin E supplement rich in gamma tocopherol

daily dose of Vitamin E supplement rich in gamma tocopherol

Sponsors & Collaborators

  • National Center for Complementary and Integrative Health (NCCIH)

    collaborator NIH

  • University of North Carolina, Chapel Hill

    lead OTHER

Principal Investigators

  • David B Peden, MD, MS · University of North Carolina at Chapel Hill, Dept of Pediatrics / Center for Environmental Medicine, Asthma and Lung Biology

Study Design

Allocation
NON_RANDOMIZED
Purpose
SCREENING
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2006-10-31
Primary Completion
2007-06-30
Completion
2007-06-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00386178 on ClinicalTrials.gov