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History of Changes for Study: NCT00895193
Alternative Options to Minimize Niacin-Induced Flushing
Latest version (submitted May 22, 2014) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 May 7, 2009 None (earliest Version on record)
2 May 13, 2009 Contacts/Locations and Study Status
3 December 3, 2009 Study Status
4 June 14, 2010 Study Status
5 January 11, 2011 Recruitment Status, Study Status and Contacts/Locations
6 February 3, 2014 Sponsor/Collaborators, Study Status, Arms and Interventions, Outcome Measures, Results and Study Design
7 May 22, 2014 Study Status and Baseline Characteristics
Comparison Format:

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Study NCT00895193
Submitted Date:  May 7, 2009 (v1)

Open or close this module Study Identification
Unique Protocol ID: 11627
Brief Title: Alternative Options to Minimize Niacin-Induced Flushing
Official Title: Alternative Options to Minimize Niacin-Induced Flushing
Secondary IDs:
Open or close this module Study Status
Record Verification: May 2009
Overall Status: Recruiting
Study Start: January 2009
Primary Completion: January 2010 [Anticipated]
Study Completion: July 2010 [Anticipated]
First Submitted: May 6, 2009
First Submitted that
Met QC Criteria:
May 7, 2009
First Posted: May 8, 2009 [Estimate]
Last Update Submitted that
Met QC Criteria:
May 7, 2009
Last Update Posted: May 8, 2009 [Estimate]
Open or close this module Sponsor/Collaborators
Sponsor: University of Kansas
Responsible Party:
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug:
U.S. FDA-regulated Device:
Data Monitoring: No
Open or close this module Study Description
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:
Open or close this module Conditions
Conditions: Hypercholesterolemia
Flushing
Keywords: Niacin
Hypercholesterolemia
Flushing
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Supportive Care
Study Phase: Not Applicable
Interventional Study Model: Parallel Assignment
Number of Arms: 4
Masking: Double (Participant, Investigator)
Allocation: Randomized
Enrollment: 100 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
Active Comparator: 1
Apple pectin 2000mg
Apple pectin
Apple pectin 2000mg
Active Comparator: 2
Aspirin 325 mg
Drug: Aspirin 325 mg
Aspirin 325 mg
Active Comparator: 3
Apple pectin 2000mg and aspirin 325 mg
Apple pectin 2000 mg + aspirin 325 mg
Apple pectin 2000mg + aspirin 32 mg
Placebo Comparator: 4
Placebo
Placebo
Placebo
Open or close this module Outcome Measures
Primary Outcome Measures:
1. Presence or absence of flushing, Flushing assessment tool
[ Time Frame: Hourly for 6 hours on day of dosing ]

Open or close this module Eligibility
Minimum Age: 21 Years
Maximum Age: 70 Years
Sex: All
Gender Based:
Accepts Healthy Volunteers: No
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.
Open or close this module Contacts/Locations
Central Contact Person: Patrick Moriarty, MD
Telephone: 913-588-4064
Email: pmoriart@kumc.edu
Study Officials: Patrick Moriarty, MD
Principal Investigator
University of Kansas Medical Center
Locations: United States, Kansas
University of Kansas Medical Center
[Recruiting]
Kansas City, Kansas, United States, 66160
Contact:Contact: JulieAnn Dutton, RD 913-588-4064 jdutton@kumc.edu
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Available IPD/Information:

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