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Effects of Psyllium on Niacin Tolerability

Primary Purpose

Flushing, Hyperlipidemias, Dyslipidemias

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Psyllium
Aspirin
Sponsored by
VA Greater Los Angeles Healthcare System
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Flushing focused on measuring Niacin, Psyllium, Dietary fiber

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts 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

Sites / Locations

  • VA West Los Angeles Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Psyllium plus Aspirin and Niacin ER

Aspirin and Niacin ER

Arm 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

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

Outcomes

Primary Outcome Measures

Global Flushing Severity Score

Secondary Outcome Measures

HDL
LDL

Full Information

First Posted
December 20, 2016
Last Updated
December 7, 2017
Sponsor
VA Greater Los Angeles Healthcare System
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1. Study Identification

Unique Protocol Identification Number
NCT03370848
Brief Title
Effects of Psyllium on Niacin Tolerability
Official Title
A Prospective Randomized, Open-Label, Crossover Study on the Effects of Psyllium on Niacin Tolerability
Study Type
Interventional

2. Study Status

Record Verification Date
December 2017
Overall Recruitment Status
Completed
Study Start Date
March 2009 (undefined)
Primary Completion Date
July 2011 (Actual)
Study Completion Date
July 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
VA Greater Los Angeles Healthcare System

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Flushing, Hyperlipidemias, Dyslipidemias
Keywords
Niacin, Psyllium, Dietary fiber

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
26 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Psyllium plus Aspirin and Niacin ER
Arm Type
Experimental
Arm 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
Arm Title
Aspirin and Niacin ER
Arm Type
Active Comparator
Arm 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
Intervention Type
Dietary Supplement
Intervention Name(s)
Psyllium
Other Intervention Name(s)
Metamucil, Cilium, Fiberall
Intervention Description
Aspirin 325 mg tablet and two 1.7gm psyllium wafers (3.4gm total) 30 minutes prior to niacin ER
Intervention Type
Drug
Intervention Name(s)
Aspirin
Other Intervention Name(s)
Bayer, Ecotrin
Intervention Description
Aspirin 325 mg tablet 30 minutes prior to niacin ER
Primary Outcome Measure Information:
Title
Global Flushing Severity Score
Time Frame
up to 6 weeks
Secondary Outcome Measure Information:
Title
HDL
Time Frame
Baseline, & end of week 6
Title
LDL
Time Frame
Baseline, & end of week 6

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Freny V Mody, MD
Organizational Affiliation
VA Greater Los Angeles Healthcare System
Official's Role
Principal Investigator
Facility Information:
Facility Name
VA West Los Angeles Medical Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90073
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Effects of Psyllium on Niacin Tolerability

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