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NCT00386178 · ClinicalTrials.gov registry record · Phase 1

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

A Phase 1 study, sponsored by University of North Carolina, Chapel Hill.

Completed
Registry status
Phase 1
Development phase
16
Enrollment target

NCT00386178: Completed Phase 1 study, sponsored by University of North Carolina, Chapel Hill.

NCT00386178 is a Phase 1 study that has completed, run by University of North Carolina, Chapel Hill. The registered enrollment target is 16 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (73% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00386178, a Phase 1 study, has completed, sponsored by University of North Carolina, Chapel Hill.

COMPLETED
Registry status
Phase 1
Development phase
16 participants
Enrollment target

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.

Interventions

  • DRUG Vitamin E supplement rich in gamma tocopherol

Trial Details

FieldValue
Enrollment Target 16 participants
Start Date 2006-10
Est. Completion 2007-06
Phase Phase 1

What the finished NCT00386178 record still lists

NCT00386178 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 16 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (73% lower).

The record links to 0 conditions, and to 1 intervention - of which Vitamin E supplement rich in gamma tocopherol is the first listed.

NCT00386178 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00386178 about?

NCT00386178 is a clinical study titled "Safety Study of a Vitamin E Supplement in Normal Volunteers and Those With Both Allergy and Asthma". 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 oth...

What is the current status of trial NCT00386178?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 16 participants. The study started on 2006-10. Estimated completion is 2007-06.

What interventions are being tested in trial NCT00386178?

The interventions under investigation include: Vitamin E supplement rich in gamma tocopherol (DRUG).

Who is sponsoring clinical trial NCT00386178?

This trial is sponsored by University of North Carolina, Chapel Hill, which has 1,109 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00386178's enrollment target sits among peer trials

16 1786th of 2000 higher than 203 of 2,000 other Phase 1 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT00386178, the US trial registry maintained by the National Library of Medicine. NCT00386178 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.