Clinical trial NCT00895193: Alternative Options to Minimize Niacin-Induced Flushing
Official title: Alternative Options to Minimize Niacin-Induced Flushing
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypercholesterolemia
Flushing
Keywords: Niacin
Hypercholesterolemia
Flushing
Lead sponsor: University of Kansas Medical Center
Sponsor class: OTHER
First posted: 2009-05-08
Enrollment: 100
Sex: ALL
Minimum age (years): 21
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


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.

Primary outcomes:
measure: Incidence of Flushing
timeFrame: Hourly for 6 hours on day of dosing
measure: Time to Flushing
timeFrame: 6 hours after dosing
measure: Duration of Flushing
timeFrame: 6 hours after dosing
measure: Maximum Flushing Severity Score
timeFrame: 6 hours after dosing
Secondary outcomes:
Other outcomes:
Locations:
city: Kansas City
country: United States
facility: University of Kansas Medical Center
state: Kansas
Study officials:
affiliation: University of Kansas Medical Center
name: Patrick Moriarty, MD
role: PRINCIPAL_INVESTIGATOR
References: