Alternative Options to Minimize Niacin-Induced Flushing

Condition(s) targeted: Hypercholesterolemia; Flushing

Intervention: Apple pectin (Other); Aspirin 325 mg (Drug); Placebo (Other)

Phase: N/A

Status: Completed

Sponsored by: Patrick Moriarty, MD, FACP, FACC

Official(s) and/or principal investigator(s):
Patrick Moriarty, MD, Principal Investigator, Affiliation: University of Kansas

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: Alternative Options to Minimize Niacin-Induced Flushing

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Supportive Care

Primary outcome:

Incidence of Flushing

Time to Flushing

Duration of Flushing

Maximum Flushing Severity Score

Minimum age: 21 Years. Maximum age: 70 Years. Gender(s): Both.

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.

University of Kansas Medical Center, Kansas City, Kansas 66160, United States

Starting date: January 2009
Last updated: May 22, 2014