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Clinical Trial 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.


Clinical Trial Description

This study involves people between 21 and 75 years. It will be conducted over a period of 8 weeks, with 4 visits, each separated by 2 weeks. The duration of each visit is 9-10 hours. We will test a different dose of quercetin in each visit. ;


Study Design

Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Supportive Care


Related Conditions & MeSH terms


NCT number NCT00913081
Study type Interventional
Source University of Pennsylvania
Contact
Status Completed
Phase Phase 4
Start date February 2009
Completion date December 2009

See also
  Status Clinical Trial Phase
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Completed NCT00930839 - Role of Prostaglandins on Niacin-Induced Flushing N/A
Completed NCT03497442 - Treatment of Asian Flushing Syndrome With Topical Alpha Agonists Early Phase 1
Completed NCT00895193 - Alternative Options to Minimize Niacin-Induced Flushing N/A
Completed NCT00536237 - MK0524A Phase IIb Study (0524A-011)(COMPLETED) Phase 2
Completed NCT00533676 - Endpoint Validation Study (0524A-015) Phase 2
Completed NCT00533611 - Effect of MK0524A on Flushing Caused by Niacin (0524A-056) Phase 3