Effects of Psyllium on Niacin Tolerability

Phase 4

Completed

• Conditions: Hyperlipidemias; Flushing; Dyslipidemias
• Interventions: Dietary Supplement: Psyllium; Drug: Aspirin

• Registration Number: NCT03370848
• Lead Sponsor: VA Greater Los Angeles Healthcare System

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-03
• Primary Completion: 2011-07
• Study Completion: 2011-07
• Study First Submitted: 2016-12-20
• Status Verified: 2017-12
• Study First Submitted QC: 2017-12-07
• Last Update Submitted: 2017-12-07
• Study First Posted: 2017-12-12
• Last Update Posted: 2017-12-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 26

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Psyllium plus Aspirin and Niacin ER	Psyllium	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
Psyllium plus Aspirin and Niacin ER	Aspirin	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
Aspirin and Niacin ER	Aspirin	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

Primary Outcome Measures

Name	Time	Method
Global Flushing Severity Score	up to 6 weeks

Secondary Outcome Measures

Name	Time	Method
HDL	Baseline, & end of week 6
LDL	Baseline, & end of week 6

Trial Locations

Locations (1)

VA West Los Angeles Medical Center; 🇺🇸 Los Angeles, California, United States