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Effects of Psyllium on Niacin Tolerability

NCT ID: NCT03370848

Last Updated: 2017-12-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

26 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-03-31

Study Completion Date

2011-07-31

Brief Summary

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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.

Detailed Description

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Conditions

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Flushing Hyperlipidemias Dyslipidemias

Keywords

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Niacin Psyllium Dietary fiber

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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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

Group Type EXPERIMENTAL

Psyllium

Intervention Type DIETARY_SUPPLEMENT

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

Aspirin

Intervention Type DRUG

Aspirin 325 mg tablet 30 minutes prior to niacin ER

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

Group Type ACTIVE_COMPARATOR

Aspirin

Intervention Type DRUG

Aspirin 325 mg tablet 30 minutes prior to niacin ER

Interventions

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Psyllium

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

Intervention Type DIETARY_SUPPLEMENT

Aspirin

Aspirin 325 mg tablet 30 minutes prior to niacin ER

Intervention Type DRUG

Other Intervention Names

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Metamucil Cilium Fiberall Bayer Ecotrin

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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VA Greater Los Angeles Healthcare System

FED

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Freny V Mody, MD

Role: PRINCIPAL_INVESTIGATOR

VA Greater Los Angeles Healthcare System

Locations

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VA West Los Angeles Medical Center

Los Angeles, California, United States

Site Status

Countries

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United States

Other Identifiers

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039

Identifier Type: -

Identifier Source: org_study_id