CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 100 enrolled
Drug / intervention
Aspirin 325 mg +2 moredrug
Likely dose
Aspirin 325 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00895193
NCT00895193N/ACompleted

Alternative Options to Minimize Niacin-Induced Flushing

Patrick Moriarty, MD, FACP, FACC·interventional·Posted May 8, 2009·Updated Jun 5, 2014

In Brief

A clinical study evaluating Apple pectin, Aspirin 325 mg, and 1 other intervention for Hypercholesterolemia and Flushing. Completed, enrolled 100 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedMay 8, 2009
Enrollment StartJan 1, 2009
Primary CompletionDec 1, 2010
TodayJul 2, 2026
Enrollment to primary: 1.9 yearsPosted 17.2 years ago

Interventions

Apple pectinother

Apple pectin 2000mg

Aspirin 325 mgdrug

Aspirin 325 mg

Placeboother

Placebo