Effects of Psyllium on Niacin Tolerability

Study Overview
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Brief Summary
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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.

Official Title
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A Prospective Randomized, Open-Label, Crossover Study on the Effects of Psyllium on Niacin Tolerability

Conditions
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Flushing, Hyperlipidemias, Dyslipidemias

Intervention / Treatment
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* Dietary Supplement: Psyllium
* Drug: Aspirin


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Psyllium plus Aspirin and Niacin ER<br>Niacin ER 500mg tablet - take 1 niacin ER 500mg tablet at least two hours before bedtime for two weeks, then increase niacin ER to two 500mg tablets (1,000 mg total) for two weeks, then increase to three niacin ER 500mg tablets (1,500 mg total) for two weeks. Aspirin 325mg tablet - take 1 aspirin 325 mg tablet 30 minutes prior to niacin ER Psyllium 1.7gm wafers - take 2 wafers (3.4 grams total) along with aspirin 30 minutes prior to niacin ER | Dietary Supplement: Psyllium<br>* Aspirin 325 mg tablet and two 1.7gm psyllium wafers (3.4gm total) 30 minutes prior to niacin ER<br>* Other names: Fiberall;Drug: Aspirin<br>* Aspirin 325 mg tablet 30 minutes prior to niacin ER<br>* Other names: Ecotrin;|
| Active Comparator: Aspirin and Niacin ER<br>Niacin ER 500mg tablet - take 1 niacin ER 500mg tablet at least two hours before bedtime for two weeks, then increase niacin ER to two 500mg tablets (1,000 mg total) for two weeks, then increase to three niacin ER 500mg tablets (1,500 mg total) for two weeks. Aspirin 325mg tablet - take 1 aspirin 325 mg tablet 30 minutes prior to niacin ER | Drug: Aspirin<br>* Aspirin 325 mg tablet 30 minutes prior to niacin ER<br>* Other names: Ecotrin;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Global Flushing Severity Score |  | up to 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HDL |  | Baseline, & end of week 6 | 
| LDL |  | Baseline, & end of week 6 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Niacin, Psyllium, Dietary fiber