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Alternative Options to Minimize Niacin-Induced Flushing

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ClinicalTrials.gov Identifier: NCT00895193
Recruitment Status : Completed
First Posted : May 8, 2009
Results First Posted : March 17, 2014
Last Update Posted : June 5, 2014
Sponsor:
Information provided by (Responsible Party):
Patrick Moriarty, MD, FACP, FACC, University of Kansas Medical Center

Tracking Information
First Submitted Date  ICMJE May 6, 2009
First Posted Date  ICMJE May 8, 2009
Results First Submitted Date  ICMJE February 3, 2014
Results First Posted Date  ICMJE March 17, 2014
Last Update Posted Date June 5, 2014
Study Start Date  ICMJE January 2009
Actual Primary Completion Date December 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 3, 2014)
  • Incidence of Flushing [ Time Frame: Hourly for 6 hours on day of dosing ]
    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.
  • Time to Flushing [ Time Frame: 6 hours after dosing ]
    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.
  • Duration of Flushing [ Time Frame: 6 hours after dosing ]
    The amount of time, in minutes, that flushing lasted. Duration of individuals without experience flushing within 6 hours was set to 0 minutes.
  • Maximum Flushing Severity Score [ Time Frame: 6 hours after dosing ]
    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.
Original Primary Outcome Measures  ICMJE
 (submitted: May 7, 2009)
Presence or absence of flushing, Flushing assessment tool [ Time Frame: Hourly for 6 hours on day of dosing ]
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Alternative Options to Minimize Niacin-Induced Flushing
Official Title  ICMJE Alternative Options to Minimize Niacin-Induced Flushing
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Supportive Care
Condition  ICMJE
  • Hypercholesterolemia
  • Flushing
Intervention  ICMJE
  • Other: Apple pectin
    Apple pectin 2000mg
  • Drug: Aspirin 325 mg
    Aspirin 325 mg
  • Other: Placebo
    Placebo
Study Arms  ICMJE
  • Active Comparator: Apple-pectin 2000mg
    Participant receives Apple pectin 2000mg 30 minutes prior to a one-time 1000mg dose of extended-release niacin.
    Intervention: Other: Apple pectin
  • Active Comparator: Regular Non-enteric coated aspirin 325mg
    Participant receives aspirin 325 mg 30 minutes prior to a one-time 1000mg dose of extended-release niacin.
    Intervention: Drug: Aspirin 325 mg
  • Active Comparator: 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.
    Interventions:
    • 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.
    Intervention: Other: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 7, 2009)
100
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 2010
Actual Primary Completion Date December 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 21 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00895193
Other Study ID Numbers  ICMJE 11627
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Patrick Moriarty, MD, FACP, FACC, University of Kansas Medical Center
Original Responsible Party Patrick Moriarty MD, University of Kansas Medical Center
Current Study Sponsor  ICMJE Patrick Moriarty, MD, FACP, FACC
Original Study Sponsor  ICMJE University of Kansas
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Patrick Moriarty, MD University of Kansas Medical Center
PRS Account University of Kansas Medical Center
Verification Date May 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP