Overview

Effects of Psyllium on Niacin Tolerability

Status:
Completed
Trial end date:
2011-07-01
Target enrollment:
0
Participant gender:
All
Summary
The purpose of this study is to determine whether psyllium is effective in reducing flushing due to niacin and also to measure the effect of niacin on cholesterol levels.
Phase:
Phase 4
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
VA Greater Los Angeles Healthcare System
Treatments:
Aspirin
Psyllium
Criteria
Inclusion Criteria:

- Patients who are starting ER niacin for clinical indication by a healthcare provider

- No prior use of psyllium for the past 2 months

- No prior use of niacin for the past 3 months

- Ability to give informed consent

- Must be reachable by telephone

Exclusion Criteria:

- Known contraindications to ER niacin, aspirin or psyllium (including: presence of
nausea, vomiting, abdominal pain, intestinal obstruction, or fecal impaction; known
hypersensitivity to ER niacin, aspirin or psyllium; severe hepatic dysfunction,
transaminitis; history of gastrointestinal bleed attributable to aspirin induced
gastritis)

- Patient who are unable to perform assessment of flushing using the standardized scales
or questionnaires

- Patients who are pregnant