Alternative Options to Minimize Niacin-Induced Flushing

Study Overview
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Brief Summary
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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.

Official Title
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Alternative Options to Minimize Niacin-Induced Flushing

Conditions
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Hypercholesterolemia, Flushing

Intervention / Treatment
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* Other: Apple pectin
* Drug: Aspirin 325 mg
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Apple-pectin 2000mg<br>Participant receives Apple pectin 2000mg 30 minutes prior to a one-time 1000mg dose of extended-release niacin. | Other: Apple pectin<br>* Apple pectin 2000mg<br>|
| Active Comparator: Regular Non-enteric coated aspirin 325mg<br>Participant receives aspirin 325 mg 30 minutes prior to a one-time 1000mg dose of extended-release niacin. | Drug: Aspirin 325 mg<br>* Aspirin 325 mg<br>|
| Active Comparator: Apple pectin + aspirin<br>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<br>* Apple pectin 2000mg<br>Drug: Aspirin 325 mg<br>* Aspirin 325 mg<br>|
| Placebo Comparator: Placebo Comparator<br>Participant receives placebo 30 minutes prior to a one-time 1000mg dose of extended-release niacin. | Other: Placebo<br>* Placebo<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Hourly for 6 hours on day of dosing | 
| 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. | 6 hours after dosing | 
| 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. | 6 hours after dosing | 
| 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. | 6 hours after dosing | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Niacin, Hypercholesterolemia, Flushing