Dyslipidemias, Flushing, Hyperlipidemias
Conditions
Keywords
Niacin, Psyllium, Dietary fiber
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.
Interventions
DIETARY_SUPPLEMENTPsyllium
Aspirin 325 mg tablet and two 1.7gm psyllium wafers (3.4gm total) 30 minutes prior to niacin ER
DRUGAspirin
Aspirin 325 mg tablet 30 minutes prior to niacin ER
Sponsors
VA Greater Los Angeles Healthcare System
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Global Flushing Severity Score | up to 6 weeks |
Secondary
| Measure | Time frame |
|---|---|
| HDL | Baseline, & end of week 6 |
| LDL | Baseline, & end of week 6 |
Countries
United States
Outcome results
None listed