Status:
COMPLETED
Effects of Psyllium on Niacin Tolerability
Lead Sponsor:
VA Greater Los Angeles Healthcare System
Conditions:
Flushing
Hyperlipidemias
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief 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.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2011
Estimated Enrollment :
26 Patients enrolled
Trial Details
Trial ID
NCT03370848
Start Date
March 1 2009
End Date
July 1 2011
Last Update
December 12 2017
Active Locations (1)
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1
VA West Los Angeles Medical Center
Los Angeles, California, United States, 90073