Alternative Options to Minimize Niacin-Induced Flushing
Hypercholesterolemia, Flushing
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
Active Comparator
Active Comparator
Active Comparator
Placebo Comparator
Apple-pectin 2000mg
Regular Non-enteric coated aspirin 325mg
Apple pectin + aspirin
Placebo Comparator
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.