Effects of Psyllium on Niacin Tolerability

Dyslipidemias Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03370848
• Other study ID #: 039
• Status: Completed
• Phase: Phase 4
• First received: December 20, 2016
• Last updated: December 7, 2017
• Start date: March 2009
• Est. completion date: July 2011

Study information

• Verified date: December 2017
• Source: VA Greater Los Angeles Healthcare System
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: July 2011
• Est. primary completion date: July 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Dyslipidemias
• Flushing
• Hyperlipidemias
• Hyperlipoproteinemias

Intervention

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

Drug:
• Aspirin
Aspirin 325 mg tablet 30 minutes prior to niacin ER

Locations

Country	Name	City	State
United States	VA West Los Angeles Medical Center	Los Angeles	California

Sponsors (1)

Lead Sponsor	Collaborator
VA Greater Los Angeles Healthcare System

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Global Flushing Severity Score		up to 6 weeks
Secondary	HDL		Baseline, & end of week 6
Secondary	LDL		Baseline, & end of week 6