Effects of Psyllium on Niacin Tolerability

VA Greater Los Angeles Healthcare System

Status and phase: Completed; Phase 4

Conditions: Hyperlipidemias; Dyslipidemias; Flushing

Treatments: Dietary Supplement: Psyllium; Drug: Aspirin

Study type: Interventional

Funder types: Other U.S. Federal agency

Identifiers

NCT03370848

039

Details and patient eligibility

About

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.

Enrollment: 26 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

---

26 participants in 2 patient groups

Psyllium plus Aspirin and Niacin ER

Experimental group

Description:

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

Treatment:

Drug: Aspirin

Dietary Supplement: Psyllium

Aspirin and Niacin ER

Active Comparator group

Description:

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

Treatment:

Drug: Aspirin