Alternative Options to Minimize Niacin-Induced Flushing

Hypercholesterolemia Clinical Trial

Official title:

Alternative Options to Minimize Niacin-Induced Flushing

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00895193
• Other study ID #: 11627
• Status: Completed
• Phase: N/A
• First received: May 6, 2009
• Last updated: May 22, 2014
• Start date: January 2009
• Est. completion date: December 2010

Study information

• Verified date: May 2014
• Source: University of Kansas Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: December 2010
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years to 70 Years

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

• Flushing
• Hypercholesterolemia

Intervention

Other:
• Apple pectin
Apple pectin 2000mg

Drug:
• Aspirin 325 mg
Aspirin 325 mg

Other:
• Placebo
Placebo

Locations

Country	Name	City	State
United States	University of Kansas Medical Center	Kansas City	Kansas

Sponsors (1)

Lead Sponsor	Collaborator
Patrick Moriarty, MD, FACP, FACC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Primary	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	No
Primary	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	No
Primary	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	Yes