Alternative Options to Minimize Niacin-Induced Flushing

NCT ID: NCT00895193

Last Updated: 2014-06-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-01-31
• Study Completion Date: 2010-12-31

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.

Conditions

Hypercholesterolemia; Flushing

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: DOUBLE

Study Groups

Apple-pectin 2000mg

Participant receives Apple pectin 2000mg 30 minutes prior to a one-time 1000mg dose of extended-release niacin.

Group Type: ACTIVE_COMPARATOR

Apple pectin

Intervention Type: OTHER

Apple pectin 2000mg

Regular Non-enteric coated aspirin 325mg

Participant receives aspirin 325 mg 30 minutes prior to a one-time 1000mg dose of extended-release niacin.

Group Type: ACTIVE_COMPARATOR

Aspirin 325 mg

Intervention Type: DRUG

Aspirin 325 mg

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.

Group Type: ACTIVE_COMPARATOR

Apple pectin

Intervention Type: OTHER

Apple pectin 2000mg

Aspirin 325 mg

Intervention Type: DRUG

Aspirin 325 mg

Placebo Comparator

Participant receives placebo 30 minutes prior to a one-time 1000mg dose of extended-release niacin.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

Placebo

Interventions

Apple pectin

Apple pectin 2000mg

Intervention Type: OTHER

Aspirin 325 mg

Aspirin 325 mg

Intervention Type: DRUG

Placebo

Placebo

Intervention Type: OTHER

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.

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Patrick Moriarty, MD, FACP, FACC

OTHER

Sponsor Role: lead

Responsible Party

Patrick Moriarty, MD, FACP, FACC

Director, Clinical Pharmacology

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Patrick Moriarty, MD

Role: PRINCIPAL_INVESTIGATOR

University of Kansas Medical Center

Locations

University of Kansas Medical Center

Kansas City, Kansas, United States

Countries

United States

Other Identifiers

11627

Identifier Type: -

Identifier Source: org_study_id