- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00895193
Alternative Options to Minimize Niacin-Induced Flushing
May 22, 2014 updated by: Patrick Moriarty, MD, FACP, FACC
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
100
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Kansas
-
Kansas City, Kansas, United States, 66160
- University of Kansas Medical Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
21 years to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Apple-pectin 2000mg
Participant receives Apple pectin 2000mg 30 minutes prior to a one-time 1000mg dose of extended-release niacin.
|
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.
|
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.
|
Apple pectin 2000mg
Aspirin 325 mg
|
Placebo Comparator: Placebo Comparator
Participant receives placebo 30 minutes prior to a one-time 1000mg dose of extended-release niacin.
|
Placebo
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Incidence of Flushing
Time Frame: Hourly for 6 hours on day of dosing
|
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.
|
Hourly for 6 hours on day of dosing
|
Time to Flushing
Time Frame: 6 hours after dosing
|
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.
|
6 hours after dosing
|
Duration of Flushing
Time Frame: 6 hours after dosing
|
The amount of time, in minutes, that flushing lasted.
Duration of individuals without experience flushing within 6 hours was set to 0 minutes.
|
6 hours after dosing
|
Maximum Flushing Severity Score
Time Frame: 6 hours after dosing
|
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.
|
6 hours after dosing
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Patrick Moriarty, MD, University of Kansas Medical Center
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2009
Primary Completion (Actual)
December 1, 2010
Study Completion (Actual)
December 1, 2010
Study Registration Dates
First Submitted
May 6, 2009
First Submitted That Met QC Criteria
May 7, 2009
First Posted (Estimate)
May 8, 2009
Study Record Updates
Last Update Posted (Estimate)
June 5, 2014
Last Update Submitted That Met QC Criteria
May 22, 2014
Last Verified
May 1, 2014
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Metabolic Diseases
- Lipid Metabolism Disorders
- Skin Manifestations
- Hyperlipidemias
- Dyslipidemias
- Hypercholesterolemia
- Flushing
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Peripheral Nervous System Agents
- Enzyme Inhibitors
- Analgesics
- Sensory System Agents
- Anti-Inflammatory Agents, Non-Steroidal
- Analgesics, Non-Narcotic
- Anti-Inflammatory Agents
- Antirheumatic Agents
- Fibrinolytic Agents
- Fibrin Modulating Agents
- Platelet Aggregation Inhibitors
- Cyclooxygenase Inhibitors
- Antipyretics
- Aspirin
Other Study ID Numbers
- 11627
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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