Alternative Options to Minimize Niacin-Induced Flushing | RxWiki

Alternative Options to Minimize Niacin-Induced Flushing

Overview[ - collapse ][ - ]

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	Hypercholesterolemia Flushing
Intervention	Other: Apple pectin Drug: Aspirin 325 mg Other: Placebo
Phase	N/A
Sponsor	Patrick Moriarty, MD, FACP, FACC
Responsible Party	University of Kansas
ClinicalTrials.gov Identifier	NCT00895193
First Received	May 6, 2009
Last Updated	February 3, 2014
Last verified	February 2014

Tracking Information[ + expand ][ + ]

First Received Date	May 6, 2009
Last Updated Date	February 3, 2014
Start Date	January 2009
Estimated Primary Completion Date	December 2010
Current 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.
Current Secondary Outcome Measures	Not Provided

Descriptive Information[ + expand ][ + ]

Brief Title	Alternative Options to Minimize Niacin-Induced Flushing
Official Title	Alternative Options to Minimize Niacin-Induced Flushing
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.
Detailed Description	Not Provided
Study Type	Interventional
Study Phase	N/A
Study Design	Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Supportive Care
Condition	Hypercholesterolemia Flushing
Intervention	Other: Apple pectin Apple pectin 2000mg Drug: Aspirin 325 mg Aspirin 325 mg Other: Placebo Placebo
Study Arm (s)	Active Comparator: Apple-pectin 2000mg Participant receives Apple pectin 2000mg 30 minutes prior to a one-time 1000mg dose of extended-release niacin. 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. 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. Placebo Comparator: Placebo Comparator Participant receives placebo 30 minutes prior to a one-time 1000mg dose of extended-release niacin.

Recruitment Information[ + expand ][ + ]

Recruitment Status	Completed
Estimated Enrollment	100
Estimated Completion Date	December 2010
Estimated Primary Completion Date	December 2010
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.
Gender	Both
Ages	21 Years
Accepts Healthy Volunteers	No
Contacts	Not Provided
Location Countries	United States

Administrative Information[ + expand ][ + ]

NCT Number	NCT00895193
Other Study ID Numbers	11627
Has Data Monitoring Committee	No
Information Provided By	University of Kansas
Study Sponsor	Patrick Moriarty, MD, FACP, FACC
Collaborators	Not Provided
Investigators	Principal Investigator: Patrick Moriarty, MD University of Kansas
Verification Date	February 2014

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