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

Completed · Phase 1

Conditions studied: Asthma

In brief

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.

Key facts

Study ID

NCT00386178

Run by

University of North Carolina, Chapel Hill

People needed

16

Starts

2006-10-01

Expected to finish

2007-06-01

Last updated by the study team

2010-12-21

Who can join

Age: 18 and older, up to 50. Sex: any. Healthy volunteers: accepted.

You may not qualify if…

• Any chronic medical condition considered by the PI as a contraindication to receiving gamma tocopherol, including significant cardiovascular disease, diabetes requiring medication, chronic renal disease, chronic thyroid disease, kidney disease or coagulation defects.
• Use of inhaled steroids, cromolyn or leukotriene inhibitors (montelukast or zafirlukast) which have been used for at least one month are allowed. Patients must be on a stable regimen of maintenance asthma therapy which has not changed in the past month prior to entrance into the study.
• NSAID or ASA use within 48 hours of beginning the study, and inability to suspended use of these medications during the length of the study.
• Use of anticoagulants including warfarin, heparin, or clopidogrel.
• Diagnosis of anemia or abnormal blood counts at screening
• Pregnancy or nursing a baby. As this is a phase I study, the potential risk to a fetus cannot be justified.
• Children will not be included in this study as the potential risk to a growing child cannot be justified.
• Adults age 51 and older are excluded as the potential for concomitant illness in this population increases the risk for confounding the data.
• Known vagal response to venipuncture
• Abnormal PT or PTT values at screening

Where it is running

• Center for Environmental Medicine, Asthma and Lung Biology at the University of North Carolina — Chapel Hill, North Carolina, United States

Full record on ClinicalTrials.gov

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