NCT00895193

Alternative Options to Minimize Niacin-Induced Flushing

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (actual)
• Sponsor: Patrick Moriarty, MD, FACP, FACC · Academic / Other
• Sex: All
• Age: 21 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Hypercholesterolemia
• Flushing

Interventions

Type	Name	Description
OTHER	Apple pectin	Apple pectin 2000mg
DRUG	Aspirin 325 mg	Aspirin 325 mg
OTHER	Placebo	Placebo

Timeline

• Start date: 2009-01-01
• Primary completion: 2010-12-01
• Completion: 2010-12-01
• First posted: 2009-05-08
• Last updated: 2014-06-05
• Results posted: 2014-03-17

Locations

1 site across 1 country: United States