Alternative Options to Minimize Niacin-Induced Flushing

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Patrick Moriarty, MD, FACP, FACC, University of Kansas Medical Center Research Institute
ClinicalTrials.gov Identifier:
NCT00895193
First received: May 6, 2009
Last updated: May 22, 2014
Last verified: May 2014
  Purpose

Niacin (Vitamin B3) is known to effectively and safely treat hypercholesterolemia. However, use of niacin is limited due to incidents of flushing which limits its acceptability. Some information suggests that applesauce can reduce the incidence and severity of flushing. The apple pectin in particular is thought to be the ingredient that affects this reaction. To determine if the apple pectin does affect flushing from niacin, the investigators will study the affects of isolated apple pectin in pill form. The investigators plan on recruiting 100 patients, and giving them 1000 mg of Niacin to induce flushing. Patients will be divided into 4 treatment groups and receive either pectin, aspirin, a combination of both, or placebo. Incidents and severity of flushing will be monitored for up to 6 hours post Niacin ingestion.


Condition Intervention
Hypercholesterolemia
Flushing
Other: Apple pectin
Drug: Aspirin 325 mg
Other: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Supportive Care
Official Title: Alternative Options to Minimize Niacin-Induced Flushing

Resource links provided by NLM:


Further study details as provided by University of Kansas:

Primary Outcome Measures:
  • Incidence of Flushing [ Time Frame: Hourly for 6 hours on day of dosing ] [ Designated as safety issue: Yes ]
    Flushing assessment performed hourly for 6 hours after niacin administration. Incidence of flushing based on if the participant experience any niacin-induced flushing during the 6 hour period after dosing. Represents # of participants that experienced event.

  • Time to Flushing [ Time Frame: 6 hours after dosing ] [ Designated as safety issue: No ]
    The time it took, in minutes, for a participant to experience any flushing. Time to flush for individuals that did not experience flushing within 6 hours was set to 360 minutes.

  • Duration of Flushing [ Time Frame: 6 hours after dosing ] [ Designated as safety issue: No ]
    The amount of time, in minutes, that flushing lasted. Duration of individuals without experience flushing within 6 hours was set to 0 minutes.

  • Maximum Flushing Severity Score [ Time Frame: 6 hours after dosing ] [ Designated as safety issue: Yes ]
    Flushing assessment performed hourly for six hours. Assessment of severity done using the validated visual analog scale (VAS) flushing assessment tool (FAST). Severity rated using a VAS from mild (1-3), moderate (4-6), severe (7-9) to very severe (10). The maximum severity score was the maximum severity score of each individual during the 6 hours of monitoring time period.


Enrollment: 100
Study Start Date: January 2009
Study Completion Date: December 2010
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Apple-pectin 2000mg
Participant receives Apple pectin 2000mg 30 minutes prior to a one-time 1000mg dose of extended-release niacin.
Other: Apple pectin
Apple pectin 2000mg
Active Comparator: Regular Non-enteric coated aspirin 325mg
Participant receives aspirin 325 mg 30 minutes prior to a one-time 1000mg dose of extended-release niacin.
Drug: Aspirin 325 mg
Aspirin 325 mg
Active Comparator: Apple pectin + aspirin
Participant receives apple pectin 2000mg and aspirin 325 mg 30 minutes prior to a one-time 1000mg dose of extended-release niacin.
Other: Apple pectin
Apple pectin 2000mg
Drug: Aspirin 325 mg
Aspirin 325 mg
Placebo Comparator: Placebo Comparator
Participant receives placebo 30 minutes prior to a one-time 1000mg dose of extended-release niacin.
Other: Placebo
Placebo

  Eligibility

Ages Eligible for Study:   21 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • An adult between 21 and 70 years of age.
  • Male or female (If female must be postmenopausal for at least 1 year, surgically sterile or using an effective form of contraception).
  • Able to speak and read English.
  • Willing to comply with study specific instructions, and complete all study procedures according to protocol.
  • Able to understand study rationale and sign informed consent.

Exclusion Criteria:

  • Females of child-bearing potential not using acceptable method of contraception and perimenopausal females.
  • History of gout
  • History of diabetes mellitus
  • History of coronary heart disease
  • History of, or currently experiencing, renal disease including, but not limited to, renal insufficiency, nephrolithiasis or chronic renal failure.
  • History of, or currently experiencing, major chronic gastrointestinal condition including gallbladder disease, liver disease and peptic ulcer disease
  • Known sensitivity to niacin, Aspirin or nonsteroidal anti-inflammatory agents (NSAIDs)
  • History of migraine or cluster headaches
  • Currently using antihistamines, aspirin or NSAIDS on a consistent basis
  • Presence or history of any medical or psychosocial condition that, in the opinion of the investigator, would limit the patient's successful participation or would compromise the patient's safe participation.
  • Lab abnormalities at screening, including but not limited to elevated liver enzymes or blood sugar levels that might indicate additional risk to the patient's continued participation.
  • Currently taking medication that might be contraindicated with the study drug or Niacin or study procedures (including Niacin, lipid-lowering drugs, chronic aspirin or laxative use).
  • Clinically significant finding from physical exam that would affect the patient's safe participation or completion of the study.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00895193

Locations
United States, Kansas
University of Kansas Medical Center
Kansas City, Kansas, United States, 66160
Sponsors and Collaborators
Patrick Moriarty, MD, FACP, FACC
Investigators
Principal Investigator: Patrick Moriarty, MD University of Kansas
  More Information

No publications provided

Responsible Party: Patrick Moriarty, MD, FACP, FACC, Director, Clinical Pharmacology, University of Kansas Medical Center Research Institute
ClinicalTrials.gov Identifier: NCT00895193     History of Changes
Other Study ID Numbers: 11627
Study First Received: May 6, 2009
Results First Received: February 3, 2014
Last Updated: May 22, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of Kansas:
Niacin
Hypercholesterolemia
Flushing

Additional relevant MeSH terms:
Hypercholesterolemia
Flushing
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Signs and Symptoms
Aspirin
Niacin
Pectin
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents
Hematologic Agents
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Antipyretics
Central Nervous System Agents

ClinicalTrials.gov processed this record on September 16, 2014