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Effects of Niacin On Fatty Acid Trapping

NCT01984073 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 26

Last updated 2020-07-09

No results posted yet for this study

Summary

The purpose of this study is to understand whether a vitamin called NIcotinic ACid vitamIN (NIACIN for short, also known as vitamin B3) helps the body process dietary fat more efficiently. This is important because people with dyslipidemia have a problem with how they process fat, which raise the risk of heart disease.

Conditions

Interventions

DRUG

ER Niacin Oral Fat Challenge

Extended release niacin 2000 mg at hour 0, followed by oral fat challenge at hour 1.

DRUG

IR Niacin Oral Fat Challenge

Nialor(R) 500mg or Placebo at hour 0, 2, 4, and 6. Oral fat challenge at hour 1 (one hour after first dose of immediate-release niacin)

OTHER

Placebo Oral Fat Challenge

Placebo at hour 0. Oral fat challenge at hour 1, followed by placebo at hours 2,4,and 6

Sponsors & Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)

    collaborator NIH

  • Arizona Pharmaceuticals Inc.

    collaborator INDUSTRY

  • University of Pennsylvania

    lead OTHER

Principal Investigators

  • Richard L Dunbar, MD · University of Pennsylvania

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
22 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-12-31
Primary Completion
2019-12-31
Completion
2019-12-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01984073 on ClinicalTrials.gov