Back to resultsAlternative Options to Minimize Niacin-Induced Flushing
Primary Purpose
Hypercholesterolemia, Flushing
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Apple pectin
Aspirin 325 mg
Placebo
Sponsored by
About this trial
This is an interventional supportive care trial for Hypercholesterolemia focused on measuring Niacin, Hypercholesterolemia, Flushing
Eligibility 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.
Sites / Locations
- University of Kansas Medical Center
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Active Comparator
Active Comparator
Active Comparator
Placebo Comparator
Arm Label
Apple-pectin 2000mg
Regular Non-enteric coated aspirin 325mg
Apple pectin + aspirin
Placebo Comparator
Arm Description
Participant receives Apple pectin 2000mg 30 minutes prior to a one-time 1000mg dose of extended-release niacin.
Participant receives aspirin 325 mg 30 minutes prior to a one-time 1000mg dose of extended-release niacin.
Participant receives apple pectin 2000mg and aspirin 325 mg 30 minutes prior to a one-time 1000mg dose of extended-release niacin.
Participant receives placebo 30 minutes prior to a one-time 1000mg dose of extended-release niacin.
Outcomes
Primary Outcome Measures
Incidence of Flushing
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
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
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
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT00895193
First Posted
May 6, 2009
Last Updated
May 22, 2014
Sponsor
Patrick Moriarty, MD, FACP, FACC
1. Study Identification
Unique Protocol Identification Number
NCT00895193
Brief Title
Alternative Options to Minimize Niacin-Induced Flushing
Official Title
Alternative Options to Minimize Niacin-Induced Flushing
Study Type
Interventional
2. Study Status
Record Verification Date
May 2014
Overall Recruitment Status
Completed
Study Start Date
January 2009 (undefined)
Primary Completion Date
December 2010 (Actual)
Study Completion Date
December 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Patrick Moriarty, MD, FACP, FACC
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypercholesterolemia, Flushing
Keywords
Niacin, Hypercholesterolemia, Flushing
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
100 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Apple-pectin 2000mg
Arm Type
Active Comparator
Arm Description
Participant receives Apple pectin 2000mg 30 minutes prior to a one-time 1000mg dose of extended-release niacin.
Arm Title
Regular Non-enteric coated aspirin 325mg
Arm Type
Active Comparator
Arm Description
Participant receives aspirin 325 mg 30 minutes prior to a one-time 1000mg dose of extended-release niacin.
Arm Title
Apple pectin + aspirin
Arm Type
Active Comparator
Arm Description
Participant receives apple pectin 2000mg and aspirin 325 mg 30 minutes prior to a one-time 1000mg dose of extended-release niacin.
Arm Title
Placebo Comparator
Arm Type
Placebo Comparator
Arm Description
Participant receives placebo 30 minutes prior to a one-time 1000mg dose of extended-release niacin.
Intervention Type
Other
Intervention Name(s)
Apple pectin
Intervention Description
Apple pectin 2000mg
Intervention Type
Drug
Intervention Name(s)
Aspirin 325 mg
Intervention Description
Aspirin 325 mg
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Placebo
Primary Outcome Measure Information:
Title
Incidence of Flushing
Description
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 Frame
Hourly for 6 hours on day of dosing
Title
Time to Flushing
Description
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.
Time Frame
6 hours after dosing
Title
Duration of Flushing
Description
The amount of time, in minutes, that flushing lasted. Duration of individuals without experience flushing within 6 hours was set to 0 minutes.
Time Frame
6 hours after dosing
Title
Maximum Flushing Severity Score
Description
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.
Time Frame
6 hours after dosing
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Patrick Moriarty, MD
Organizational Affiliation
University of Kansas Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Kansas Medical Center
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160
Country
United States
12. IPD Sharing Statement
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Alternative Options to Minimize Niacin-Induced Flushing
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