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Effects of Psyllium on Niacin Tolerability

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03370848
Recruitment Status : Completed
First Posted : December 12, 2017
Last Update Posted : December 12, 2017
Sponsor:
Information provided by (Responsible Party):
VA Greater Los Angeles Healthcare System

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.

Condition or disease Intervention/treatment Phase
Flushing Hyperlipidemias Dyslipidemias Dietary Supplement: Psyllium Drug: Aspirin Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 26 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: A Prospective Randomized, Open-Label, Crossover Study on the Effects of Psyllium on Niacin Tolerability
Study Start Date : March 2009
Actual Primary Completion Date : July 2011
Actual Study Completion Date : July 2011

Resource links provided by the National Library of Medicine


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:
  • Bayer
  • Ecotrin

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:
  • Bayer
  • Ecotrin




Primary Outcome Measures :
  1. Global Flushing Severity Score [ Time Frame: up to 6 weeks ]

Secondary Outcome Measures :
  1. HDL [ Time Frame: Baseline, & end of week 6 ]
  2. LDL [ Time Frame: Baseline, & end of week 6 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03370848


Locations
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United States, California
VA West Los Angeles Medical Center
Los Angeles, California, United States, 90073
Sponsors and Collaborators
VA Greater Los Angeles Healthcare System
Investigators
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Principal Investigator: Freny V Mody, MD VA Greater Los Angeles Healthcare System
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Responsible Party: VA Greater Los Angeles Healthcare System
ClinicalTrials.gov Identifier: NCT03370848    
Other Study ID Numbers: 039
First Posted: December 12, 2017    Key Record Dates
Last Update Posted: December 12, 2017
Last Verified: December 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by VA Greater Los Angeles Healthcare System:
Niacin
Psyllium
Dietary fiber
Additional relevant MeSH terms:
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Dyslipidemias
Hyperlipidemias
Flushing
Lipid Metabolism Disorders
Metabolic Diseases
Skin Manifestations
Aspirin
Psyllium
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Antipyretics
Cathartics
Gastrointestinal Agents