Alternative Options to Minimize Niacin-Induced Flushing

NCT00895193 | Completed Results

• 1 other identifier: 11627
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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

Keywords

Niacin; Hypercholesterolemia; Flushing

Outcome Measures

Primary Outcomes (4)

• 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

Study Arms (4)

Apple-pectin 2000mg

ACTIVE COMPARATOR

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

Other: Apple pectin

Regular Non-enteric coated aspirin 325mg

ACTIVE COMPARATOR

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

Drug: Aspirin 325 mg

Apple pectin + aspirin

ACTIVE COMPARATOR

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; Drug: Aspirin 325 mg

Placebo Comparator

PLACEBO COMPARATOR

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

Other: Placebo

Interventions

Apple pectin OTHER

Apple pectin 2000mg

Apple pectin + aspirin; Apple-pectin 2000mg

Aspirin 325 mg DRUG

Aspirin 325 mg

Apple pectin + aspirin; Regular Non-enteric coated aspirin 325mg

Placebo OTHER

Placebo

Placebo Comparator

Eligibility Criteria

• Age: 21 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Patrick Moriarty, MD, FACP, FACC: lead

Study Sites (1)

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

Location

MeSH Terms

Conditions

Hypercholesterolemia; Flushing

Interventions

Aspirin

Condition Hierarchy (Ancestors)

Hyperlipidemias; Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Skin Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Salicylates; Hydroxybenzoates; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Limitations and Caveats

Limitations include: pilot design, small sample size, short duration of a one-time niacin dose, utilization of only one niacin formulation.

Results Point of Contact

• Title: Julie-Ann Dutton, MS, RD
• Organization: University of Kansas Medical Center

jdutton@kumc.edu

(913) 588-4064

Study Officials

• Patrick Moriarty, MD

  University of Kansas Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director, Clinical Pharmacology

Study Record Dates

• First Submitted: May 6, 2009
• First Posted: May 8, 2009
• Study Start: January 1, 2009
• Primary Completion: December 1, 2010
• Study Completion: December 1, 2010
• Last Updated: June 5, 2014
• Results First Posted: March 17, 2014

Record last verified: 2014-05

Locations

US (1)