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OpenTrials
Completed

NCT Number: NCT03370848

Effects of Psyllium on Niacin Tolerability

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.

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Key information

Conditions

Flushing Dyslipidemias Hyperlipidemias Lipid Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases Pathological Conditions, Signs and Symptoms Signs and Symptoms Skin Manifestations

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

VA West Los Angeles Medical Center

Los Angeles, California, 90073, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Psyllium

Dietary Supplement

Aspirin 325 mg tablet and two 1.7gm psyllium wafers (3.4gm total) 30 minutes prior to niacin ER

Other names: Metamucil, Cilium, Fiberall

Aspirin

Drug

Aspirin 325 mg tablet 30 minutes prior to niacin ER

Other names: Bayer, Ecotrin

Primary outcomes

  1. Global Flushing Severity Score

    Time frame: up to 6 weeks

Secondary outcomes

  1. HDL

    Time frame: Baseline, & end of week 6

  2. LDL

    Time frame: Baseline, & end of week 6

Sponsors and collaborators

Lead sponsor

VA Greater Los Angeles Healthcare System

Fed

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2011
Study completion
2011
First posted
Dec 12, 2017
Registry last updated
Dec 12, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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