Effects of Psyllium on Niacin Tolerability

Overview

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.

Full Title of Study: “A Prospective Randomized, Open-Label, Crossover Study on the Effects of Psyllium on Niacin Tolerability”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Crossover Assignment
    • Primary Purpose: Supportive Care
    • Masking: None (Open Label)
  • Study Primary Completion Date: July 2011

Interventions

  • Dietary Supplement: Psyllium
    • Aspirin 325 mg tablet and two 1.7gm psyllium wafers (3.4gm total) 30 minutes prior to niacin ER
  • Drug: Aspirin
    • Aspirin 325 mg tablet 30 minutes prior to niacin ER

Arms, Groups and Cohorts

  • Experimental: Psyllium plus Aspirin and Niacin ER
    • 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
  • Active Comparator: Aspirin and Niacin ER
    • 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

Clinical Trial Outcome Measures

Primary Measures

  • Global Flushing Severity Score
    • Time Frame: up to 6 weeks

Secondary Measures

  • HDL
    • Time Frame: Baseline, & end of week 6
  • LDL
    • Time Frame: Baseline, & end of week 6

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • VA Greater Los Angeles Healthcare System
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Freny V Mody, MD, Principal Investigator, VA Greater Los Angeles Healthcare System

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