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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

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Supportive Care
Conditions Hypercholesterolemia
Flushing
Interventions Other: Apple pectin
Drug: Aspirin 325 mg
Other: Placebo
Enrollment 100
Recruitment Details Initial screening occurred over the telephone. Subjects that met preliminary study criteria were scheduled for a screening visit. Recruitment was conducted at the University of Kansas Medical Center.
Pre-assignment Details  
Arm/Group Title Apple-pectin 2000mg Regular Non-enteric Coated Aspirin 325mg Apple Pectin + Aspirin Placebo Comparator
Hide Arm/Group Description Participant receives Apple pectin 2000mg 30 minutes prior to a one-time 1000mg dose of extended-release niacin. Participant receives aspirin 325 mg 30 minutes prior to a one-time 1000mg dose of extended-release niacin. Participant receives apple pectin 2000mg and aspirin 325 mg 30 minutes prior to a one-time 1000mg dose of extended-release niacin. Participant receives placebo 30 minutes prior to a one-time 1000mg dose of extended-release niacin.
Period Title: Overall Study
Started 25 25 25 25
Completed 25 25 25 25
Not Completed 0 0 0 0
Arm/Group Title Apple-pectin 2000mg Regular Non-enteric Coated Aspirin 325mg Apple Pectin + Aspirin Placebo Comparator Total
Hide Arm/Group Description Participant receives Apple pectin 2000mg 30 minutes prior to a one-time 1000mg dose of extended-release niacin. Participant receives aspirin 325 mg 30 minutes prior to a one-time 1000mg dose of extended-release niacin. Participant receives apple pectin 2000mg and aspirin 325 mg 30 minutes prior to a one-time 1000mg dose of extended-release niacin. Participant receives placebo 30 minutes prior to a one-time 1000mg dose of extended-release niacin. Total of all reporting groups
Overall Number of Baseline Participants 25 25 25 25 100
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 25 participants 25 participants 25 participants 25 participants 100 participants
34  (11.5) 40  (13.3) 40  (12.3) 38  (12.7) 38.2  (12.5)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 25 participants 25 participants 25 participants 25 participants 100 participants
Female
11
  44.0%
12
  48.0%
11
  44.0%
11
  44.0%
45
  45.0%
Male
14
  56.0%
13
  52.0%
14
  56.0%
14
  56.0%
55
  55.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 25 participants 25 participants 25 participants 25 participants 100 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
4
  16.0%
9
  36.0%
5
  20.0%
5
  20.0%
23
  23.0%
White
16
  64.0%
15
  60.0%
20
  80.0%
20
  80.0%
71
  71.0%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
5
  20.0%
1
   4.0%
0
   0.0%
0
   0.0%
6
   6.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 25 participants 25 participants 25 participants 25 participants 100 participants
25 25 25 25 100
Body Mass Index  
Mean (Standard Deviation)
Unit of measure:  Kg/m2
Number Analyzed 25 participants 25 participants 25 participants 25 participants 100 participants
26  (5.5) 27  (6.2) 26  (5.3) 26  (5.0) 26.4  (5.4)
Waist Circumference  
Mean (Standard Deviation)
Unit of measure:  Inches
Number Analyzed 25 participants 25 participants 25 participants 25 participants 100 participants
35  (6.1) 36  (6.3) 34  (5.0) 35  (5.3) 35  (5.65)
1.Primary Outcome
Title Incidence of Flushing
Hide Description 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 Frame Hourly for 6 hours on day of dosing
Hide Outcome Measure Data
Hide Analysis Population Description
This was a single-site, randomized trial, 4-arm parallel design trial. Each arm consisted of 25 randomized participants. All participants completed the study.
Arm/Group Title Apple-pectin 2000mg Regular Non-enteric Coated Aspirin 325mg Apple Pectin + Aspirin Placebo Comparator
Hide Arm/Group Description:
Participant receives Apple pectin 2000mg 30 minutes prior to a one-time 1000mg dose of extended-release niacin.
Participant receives aspirin 325 mg 30 minutes prior to a one-time 1000mg dose of extended-release niacin.
Participant receives apple pectin 2000mg and aspirin 325 mg 30 minutes prior to a one-time 1000mg dose of extended-release niacin.
Participant receives placebo 30 minutes prior to a one-time 1000mg dose of extended-release niacin.
Overall Number of Participants Analyzed 25 25 25 25
Measure Type: Number
Unit of Measure: participants
22 18 20 23
2.Primary Outcome
Title Time to Flushing
Hide Description 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.
Time Frame 6 hours after dosing
Hide Outcome Measure Data
Hide Analysis Population Description
All participants randomized to the study completed the study. Each arm had 25 participants.
Arm/Group Title Apple-pectin 2000mg Regular Non-enteric Coated Aspirin 325mg Apple Pectin + Aspirin Placebo Comparator
Hide Arm/Group Description:
Participant receives Apple pectin 2000mg 30 minutes prior to a one-time 1000mg dose of extended-release niacin.
Participant receives aspirin 325 mg 30 minutes prior to a one-time 1000mg dose of extended-release niacin.
Participant receives apple pectin 2000mg and aspirin 325 mg 30 minutes prior to a one-time 1000mg dose of extended-release niacin.
Participant receives placebo 30 minutes prior to a one-time 1000mg dose of extended-release niacin.
Overall Number of Participants Analyzed 25 25 25 25
Mean (Standard Deviation)
Unit of Measure: minutes
75.4  (51.7) 48.7  (33.8) 58.8  (42.5) 58.1  (66.2)
3.Primary Outcome
Title Duration of Flushing
Hide Description The amount of time, in minutes, that flushing lasted. Duration of individuals without experience flushing within 6 hours was set to 0 minutes.
Time Frame 6 hours after dosing
Hide Outcome Measure Data
Hide Analysis Population Description
All participants randomized to the study completed the study. Each arm had 25 participants.
Arm/Group Title Apple-pectin 2000mg Regular Non-enteric Coated Aspirin 325mg Apple Pectin + Aspirin Placebo Comparator
Hide Arm/Group Description:
Participant receives Apple pectin 2000mg 30 minutes prior to a one-time 1000mg dose of extended-release niacin.
Participant receives aspirin 325 mg 30 minutes prior to a one-time 1000mg dose of extended-release niacin.
Participant receives apple pectin 2000mg and aspirin 325 mg 30 minutes prior to a one-time 1000mg dose of extended-release niacin.
Participant receives placebo 30 minutes prior to a one-time 1000mg dose of extended-release niacin.
Overall Number of Participants Analyzed 25 25 25 25
Mean (Standard Deviation)
Unit of Measure: minutes
43.3  (35.7) 52.7  (53.5) 58.3  (40.2) 88  (66)
4.Primary Outcome
Title Maximum Flushing Severity Score
Hide Description 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.
Time Frame 6 hours after dosing
Hide Outcome Measure Data
Hide Analysis Population Description
All participants randomized to the study completed the study. Each arm had 25 participants.
Arm/Group Title Apple-pectin 2000mg Regular Non-enteric Coated Aspirin 325mg Apple Pectin + Aspirin Placebo Comparator
Hide Arm/Group Description:
Participant receives Apple pectin 2000mg 30 minutes prior to a one-time 1000mg dose of extended-release niacin.
Participant receives aspirin 325 mg 30 minutes prior to a one-time 1000mg dose of extended-release niacin.
Participant receives apple pectin 2000mg and aspirin 325 mg 30 minutes prior to a one-time 1000mg dose of extended-release niacin.
Participant receives placebo 30 minutes prior to a one-time 1000mg dose of extended-release niacin.
Overall Number of Participants Analyzed 25 25 25 25
Mean (Standard Deviation)
Unit of Measure: units on a scale
3.2  (2.7) 2.8  (2.6) 3.3  (2.5) 3.6  (2.6)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Apple-pectin 2000mg Regular Non-enteric Coated Aspirin 325mg Apple Pectin + Aspirin Placebo Comparator
Hide Arm/Group Description Participant receives Apple pectin 2000mg 30 minutes prior to a one-time 1000mg dose of extended-release niacin. Participant receives aspirin 325 mg 30 minutes prior to a one-time 1000mg dose of extended-release niacin. Participant receives apple pectin 2000mg and aspirin 325 mg 30 minutes prior to a one-time 1000mg dose of extended-release niacin. Participant receives placebo 30 minutes prior to a one-time 1000mg dose of extended-release niacin.
All-Cause Mortality
Apple-pectin 2000mg Regular Non-enteric Coated Aspirin 325mg Apple Pectin + Aspirin Placebo Comparator
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/-- 
Hide Serious Adverse Events
Apple-pectin 2000mg Regular Non-enteric Coated Aspirin 325mg Apple Pectin + Aspirin Placebo Comparator
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/25 (0.00%)   0/25 (0.00%)   0/25 (0.00%)   0/25 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Apple-pectin 2000mg Regular Non-enteric Coated Aspirin 325mg Apple Pectin + Aspirin Placebo Comparator
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/25 (0.00%)   0/25 (0.00%)   0/25 (0.00%)   0/25 (0.00%) 
Limitations include: pilot design, small sample size, short duration of a one-time niacin dose, utilization of only one niacin formulation.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Julie-Ann Dutton, MS, RD
Organization: University of Kansas Medical Center
Phone: (913) 588-4064
EMail: jdutton@kumc.edu
Layout table for additonal information
Responsible Party: Patrick Moriarty, MD, FACP, FACC, University of Kansas Medical Center
ClinicalTrials.gov Identifier: NCT00895193    
Other Study ID Numbers: 11627
First Submitted: May 6, 2009
First Posted: May 8, 2009
Results First Submitted: February 3, 2014
Results First Posted: March 17, 2014
Last Update Posted: June 5, 2014