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NCT00913081 · ClinicalTrials.gov registry record · Phase 4
Advancing Niacin by Inhibiting Flushing (ANTI-FLUSH)
A Phase 4 study of Flushing, sponsored by University of Pennsylvania.
- Completed
- Registry status
- Phase 4
- Development phase
- 17
- Enrollment target
- 2
- Study locations
NCT00913081: Completed Phase 4 study of Flushing, sponsored by University of Pennsylvania.
NCT00913081 is a Phase 4 study of Flushing that has completed, run by University of Pennsylvania. The registered enrollment target is 17 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (97% lower). The trial reports 2 study locations across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00913081, a Phase 4 study of Flushing, has completed, sponsored by University of Pennsylvania.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 17 participants
- Enrollment target
- 2
- Study locations
Study Summary
Niacin, or vitamin B3, is known to improve cholesterol disorders and is the most effective drug to raise HDL, or the "good cholesterol". The use of niacin has been limited because of a peculiar adverse effect referred to as "flushing', which consists of redness, warmth, tingling and burning. A recent animal study suggests that flavonoids may prevent flushing due to niacin better than drugs like aspirin. The ANTI-FLUSH study is being done to assess whether a presently available dietary supplement known as quercetin, which is a flavonoid, can reduce the flushing that occurs with niacin. We will also assess whether using quercetin to prevent flushing from niacin, can improve how niacin lowers cholesterol.
Primary Outcome
Laser Doppler flowmetry at the malar eminence measures blood flow quantitatively as red blood cell flux. Flux index is the fold-change in flux over baseline. Flux index primary peak is the maximum flux index between 0-4 hours after niacin.
Conditions Studied
Interventions
- DIETARY_SUPPLEMENT Placebo
- DIETARY_SUPPLEMENT Quercetin
Study Locations (2)
Pennsylvania
- CTRC Univ. of Penn - Andrew Mutch Bldg., 4th floor - Philadelphia
- University of Pennsylvania - Philadelphia
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 17 participants |
| Start Date | 2009-02 |
| Est. Completion | 2009-12 |
| Phase | Phase 4 |
What the finished NCT00913081 record still lists
NCT00913081 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 17 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (97% lower).
The record links to 1 condition, with Flushing appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT00913081 reports a single indexed study location in Pennsylvania.
Frequently Asked Questions
What is clinical trial NCT00913081 about?
NCT00913081 is a clinical study titled "Advancing Niacin by Inhibiting Flushing (ANTI-FLUSH)". Niacin, or vitamin B3, is known to improve cholesterol disorders and is the most effective drug to raise HDL, or the "good cholesterol". The use of niacin has been limited because of a peculiar adverse effect referred to as "flushing', which consists of redness, warmth, tingling and burning. A recen...
What is the current status of trial NCT00913081?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 17 participants. The study started on 2009-02. Estimated completion is 2009-12.
What conditions does trial NCT00913081 study?
This clinical trial studies the following conditions: Flushing.
What interventions are being tested in trial NCT00913081?
The interventions under investigation include: Placebo (DIETARY_SUPPLEMENT), Quercetin (DIETARY_SUPPLEMENT).
Who is sponsoring clinical trial NCT00913081?
This trial is sponsored by University of Pennsylvania, which has 1,423 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00913081 being conducted?
This trial has 2 study locations across Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Flushing
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT00913081's enrollment target sits among peer trials
17 1855th of 2000 higher than 132 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 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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