Effects of Psyllium on Niacin Tolerability

December 7, 2017 updated by: VA Greater Los Angeles Healthcare System

A Prospective Randomized, Open-Label, Crossover Study on the 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

26

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Los Angeles, California, United States, 90073
        • VA West Los Angeles Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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
Dietary supplement: Psyllium
Aspirin 325 mg tablet and two 1.7gm psyllium wafers (3.4gm total) 30 minutes prior to niacin ER
Other Names:
  • Metamucil
  • Cilium
  • Fiberall
Drug: Aspirin
Aspirin 325 mg tablet 30 minutes prior to niacin ER
Other Names:
  • Ecotrin
  • Bayer
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
Drug: Aspirin
Aspirin 325 mg tablet 30 minutes prior to niacin ER
Other Names:
  • Ecotrin
  • Bayer

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Global Flushing Severity Score
Time Frame: up to 6 weeks
up to 6 weeks

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

VA Greater Los Angeles Healthcare System

Investigators

  • Principal Investigator: Freny V Mody, MD, VA Greater Los Angeles Healthcare System

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2009

Primary Completion (Actual)

July 1, 2011

Study Completion (Actual)

July 1, 2011

Study Registration Dates

First Submitted

December 20, 2016

First Submitted That Met QC Criteria

December 7, 2017

First Posted (Actual)

December 12, 2017

Study Record Updates

Last Update Posted (Actual)

December 12, 2017

Last Update Submitted That Met QC Criteria

December 7, 2017

Last Verified

December 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 039

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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