Clinical Trial: Alternative Options to Minimize Niacin-Induced Flushing

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Alternative Options to Minimize Niacin-Induced Flushing

Brief Summary: Niacin (Vitamin B3) is known to effectively and safely treat hypercholesterolemia. However, use of niacin is limited due to incidents of flushing which limits its acceptability. Some information suggests that applesauce can reduce the incidence and severity of flushing. The apple pectin in particular is thought to be the ingredient that affects this reaction. To determine if the apple pectin does affect flushing from niacin, the investigators will study the affects of isolated apple pectin in pill form. The investigators plan on recruiting 100 patients, and giving them 1000 mg of Niacin to induce flushing. Patients will be divided into 4 treatment groups and receive either pectin, aspirin, a combination of both, or placebo. Incidents and severity of flushing will be monitored for up to 6 hours post Niacin ingestion.

Detailed Summary:
Sponsor: Patrick Moriarty, MD, FACP, FACC

Current Primary Outcome:

• Incidence of Flushing [ Time Frame: Hourly for 6 hours on day of dosing ]
  Flushing assessment performed hourly for 6 hours after niacin administration. Incidence of flushing based on if the participant experience any niacin-induced flushing during the 6 hour period after dosing. Represents # of participants that experienced event.
• Time to Flushing [ Time Frame: 6 hours after dosing ]
  The time it took, in minutes, for a participant to experience any flushing. Time to flush for individuals that did not experience flushing within 6 hours was set to 360 minutes.
• Duration of Flushing [ Time Frame: 6 hours after dosing ]
  The amount of time, in minutes, that flushing lasted. Duration of individuals without experience flushing within 6 hours was set to 0 minutes.
• Maximum Flushing Severity Score [ Time Frame: 6 hours after dosing ]
  Flushing assessment performed hourly for six hours. Assessment of severity done using the validated visual analog scale (VAS) flushing assessment tool (FAST). Severity rated using a VAS from mild (1-3), moderate (4-6), severe (7-9) to very severe (10). The maximum severity score was the maximum severity score of each individual during the 6 hours of monitoring time period.

Original Primary Outcome: Presence or absence of flushing, Flushing assessment tool [ Time Frame: Hourly for 6 hours on day of dosing ]

Current Secondary Outcome:

Original Secondary Outcome:

Information By: University of Kansas Medical Center

Dates:
Date Received: May 6, 2009
Date Started: January 2009
Date Completion:
Last Updated: May 22, 2014
Last Verified: May 2014