NCT03370848

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
26

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Mar 2009

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2009

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2011

Completed
5.5 years until next milestone

First Submitted

Initial submission to the registry

December 20, 2016

Completed
12 months until next milestone

First Posted

Study publicly available on registry

December 12, 2017

Completed
Last Updated

December 12, 2017

Status Verified

December 1, 2017

Enrollment Period

2.3 years

First QC Date

December 20, 2016

Last Update Submit

December 7, 2017

Conditions

FlushingHyperlipidemiasDyslipidemias

Keywords

NiacinPsylliumDietary fiber

Outcome Measures

Primary Outcomes (1)

  • Global Flushing Severity Score

    up to 6 weeks

Secondary Outcomes (2)

  • HDL

    Baseline, & end of week 6

  • LDL

    Baseline, & end of week 6

Study Arms (2)

Psyllium plus Aspirin and Niacin ER

EXPERIMENTAL

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: PsylliumDrug: Aspirin

Aspirin and Niacin ER

ACTIVE COMPARATOR

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

Interventions

PsylliumDIETARY_SUPPLEMENT

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

Also known as: Metamucil, Cilium, Fiberall
Psyllium plus Aspirin and Niacin ER
AspirinDRUG

Aspirin 325 mg tablet 30 minutes prior to niacin ER

Also known as: Bayer, Ecotrin
Aspirin and Niacin ERPsyllium plus Aspirin and Niacin ER

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

VA West Los Angeles Medical Center

Los Angeles, California, 90073, United States

Location

MeSH Terms

Conditions

FlushingHyperlipidemiasDyslipidemias

Interventions

PsylliumAspirin

Condition Hierarchy (Ancestors)

Skin ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsLipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Plant ExtractsPlant PreparationsBiological ProductsComplex MixturesSalicylatesHydroxybenzoatesPhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic Chemicals

Study Officials

  • Freny V Mody, MD

    VA Greater Los Angeles Healthcare System

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
CROSSOVER
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 20, 2016

First Posted

December 12, 2017

Study Start

March 1, 2009

Primary Completion

July 1, 2011

Study Completion

July 1, 2011

Last Updated

December 12, 2017

Record last verified: 2017-12

Data Sharing

IPD Sharing
Will not share

Locations

US(1)