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Trial Outcomes & Findings for Alternative Options to Minimize Niacin-Induced Flushing (NCT NCT00895193)

NCT ID: NCT00895193

Last Updated: 2014-06-05

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

100 participants

Primary outcome timeframe

Hourly for 6 hours on day of dosing

Results posted on

2014-06-05

Participant Flow

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.

Participant milestones

Participant milestones
Measure
Apple-pectin 2000mg
Participant receives Apple pectin 2000mg 30 minutes prior to a one-time 1000mg dose of extended-release niacin.
Regular Non-enteric Coated Aspirin 325mg
Participant receives aspirin 325 mg 30 minutes prior to a one-time 1000mg dose of extended-release niacin.
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.
Placebo Comparator
Participant receives placebo 30 minutes prior to a one-time 1000mg dose of extended-release niacin.
Overall Study
STARTED
25
25
25
25
Overall Study
COMPLETED
25
25
25
25
Overall Study
NOT COMPLETED
0
0
0
0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Alternative Options to Minimize Niacin-Induced Flushing

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Apple-pectin 2000mg
n=25 Participants
Participant receives Apple pectin 2000mg 30 minutes prior to a one-time 1000mg dose of extended-release niacin.
Regular Non-enteric Coated Aspirin 325mg
n=25 Participants
Participant receives aspirin 325 mg 30 minutes prior to a one-time 1000mg dose of extended-release niacin.
Apple Pectin + Aspirin
n=25 Participants
Participant receives apple pectin 2000mg and aspirin 325 mg 30 minutes prior to a one-time 1000mg dose of extended-release niacin.
Placebo Comparator
n=25 Participants
Participant receives placebo 30 minutes prior to a one-time 1000mg dose of extended-release niacin.
Total
n=100 Participants
Total of all reporting groups
Age, Continuous
34 years
STANDARD_DEVIATION 11.5 • n=5 Participants
40 years
STANDARD_DEVIATION 13.3 • n=7 Participants
40 years
STANDARD_DEVIATION 12.3 • n=5 Participants
38 years
STANDARD_DEVIATION 12.7 • n=4 Participants
38.2 years
STANDARD_DEVIATION 12.5 • n=21 Participants
Sex: Female, Male
Female
11 Participants
n=5 Participants
12 Participants
n=7 Participants
11 Participants
n=5 Participants
11 Participants
n=4 Participants
45 Participants
n=21 Participants
Sex: Female, Male
Male
14 Participants
n=5 Participants
13 Participants
n=7 Participants
14 Participants
n=5 Participants
14 Participants
n=4 Participants
55 Participants
n=21 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
0 Participants
n=4 Participants
0 Participants
n=21 Participants
Race (NIH/OMB)
Asian
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
0 Participants
n=4 Participants
0 Participants
n=21 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
0 Participants
n=4 Participants
0 Participants
n=21 Participants
Race (NIH/OMB)
Black or African American
4 Participants
n=5 Participants
9 Participants
n=7 Participants
5 Participants
n=5 Participants
5 Participants
n=4 Participants
23 Participants
n=21 Participants
Race (NIH/OMB)
White
16 Participants
n=5 Participants
15 Participants
n=7 Participants
20 Participants
n=5 Participants
20 Participants
n=4 Participants
71 Participants
n=21 Participants
Race (NIH/OMB)
More than one race
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
0 Participants
n=4 Participants
0 Participants
n=21 Participants
Race (NIH/OMB)
Unknown or Not Reported
5 Participants
n=5 Participants
1 Participants
n=7 Participants
0 Participants
n=5 Participants
0 Participants
n=4 Participants
6 Participants
n=21 Participants
Region of Enrollment
United States
25 participants
n=5 Participants
25 participants
n=7 Participants
25 participants
n=5 Participants
25 participants
n=4 Participants
100 participants
n=21 Participants
Body Mass Index
26 kg/m2
STANDARD_DEVIATION 5.5 • n=5 Participants
27 kg/m2
STANDARD_DEVIATION 6.2 • n=7 Participants
26 kg/m2
STANDARD_DEVIATION 5.3 • n=5 Participants
26 kg/m2
STANDARD_DEVIATION 5.0 • n=4 Participants
26.4 kg/m2
STANDARD_DEVIATION 5.4 • n=21 Participants
Waist Circumference
35 inches
STANDARD_DEVIATION 6.1 • n=5 Participants
36 inches
STANDARD_DEVIATION 6.3 • n=7 Participants
34 inches
STANDARD_DEVIATION 5.0 • n=5 Participants
35 inches
STANDARD_DEVIATION 5.3 • n=4 Participants
35 inches
STANDARD_DEVIATION 5.65 • n=21 Participants

PRIMARY outcome

Timeframe: Hourly for 6 hours on day of dosing

Population: This was a single-site, randomized trial, 4-arm parallel design trial. Each arm consisted of 25 randomized participants. All participants completed the study.

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.

Outcome measures

Outcome measures
Measure
Apple-pectin 2000mg
n=25 Participants
Participant receives Apple pectin 2000mg 30 minutes prior to a one-time 1000mg dose of extended-release niacin.
Regular Non-enteric Coated Aspirin 325mg
n=25 Participants
Participant receives aspirin 325 mg 30 minutes prior to a one-time 1000mg dose of extended-release niacin.
Apple Pectin + Aspirin
n=25 Participants
Participant receives apple pectin 2000mg and aspirin 325 mg 30 minutes prior to a one-time 1000mg dose of extended-release niacin.
Placebo Comparator
n=25 Participants
Participant receives placebo 30 minutes prior to a one-time 1000mg dose of extended-release niacin.
Incidence of Flushing
22 participants
18 participants
20 participants
23 participants

PRIMARY outcome

Timeframe: 6 hours after dosing

Population: All participants randomized to the study completed the study. Each arm had 25 participants.

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.

Outcome measures

Outcome measures
Measure
Apple-pectin 2000mg
n=25 Participants
Participant receives Apple pectin 2000mg 30 minutes prior to a one-time 1000mg dose of extended-release niacin.
Regular Non-enteric Coated Aspirin 325mg
n=25 Participants
Participant receives aspirin 325 mg 30 minutes prior to a one-time 1000mg dose of extended-release niacin.
Apple Pectin + Aspirin
n=25 Participants
Participant receives apple pectin 2000mg and aspirin 325 mg 30 minutes prior to a one-time 1000mg dose of extended-release niacin.
Placebo Comparator
n=25 Participants
Participant receives placebo 30 minutes prior to a one-time 1000mg dose of extended-release niacin.
Time to Flushing
75.4 minutes
Standard Deviation 51.7
48.7 minutes
Standard Deviation 33.8
58.8 minutes
Standard Deviation 42.5
58.1 minutes
Standard Deviation 66.2

PRIMARY outcome

Timeframe: 6 hours after dosing

Population: All participants randomized to the study completed the study. Each arm had 25 participants.

The amount of time, in minutes, that flushing lasted. Duration of individuals without experience flushing within 6 hours was set to 0 minutes.

Outcome measures

Outcome measures
Measure
Apple-pectin 2000mg
n=25 Participants
Participant receives Apple pectin 2000mg 30 minutes prior to a one-time 1000mg dose of extended-release niacin.
Regular Non-enteric Coated Aspirin 325mg
n=25 Participants
Participant receives aspirin 325 mg 30 minutes prior to a one-time 1000mg dose of extended-release niacin.
Apple Pectin + Aspirin
n=25 Participants
Participant receives apple pectin 2000mg and aspirin 325 mg 30 minutes prior to a one-time 1000mg dose of extended-release niacin.
Placebo Comparator
n=25 Participants
Participant receives placebo 30 minutes prior to a one-time 1000mg dose of extended-release niacin.
Duration of Flushing
43.3 minutes
Standard Deviation 35.7
52.7 minutes
Standard Deviation 53.5
58.3 minutes
Standard Deviation 40.2
88 minutes
Standard Deviation 66

PRIMARY outcome

Timeframe: 6 hours after dosing

Population: All participants randomized to the study completed the study. Each arm had 25 participants.

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.

Outcome measures

Outcome measures
Measure
Apple-pectin 2000mg
n=25 Participants
Participant receives Apple pectin 2000mg 30 minutes prior to a one-time 1000mg dose of extended-release niacin.
Regular Non-enteric Coated Aspirin 325mg
n=25 Participants
Participant receives aspirin 325 mg 30 minutes prior to a one-time 1000mg dose of extended-release niacin.
Apple Pectin + Aspirin
n=25 Participants
Participant receives apple pectin 2000mg and aspirin 325 mg 30 minutes prior to a one-time 1000mg dose of extended-release niacin.
Placebo Comparator
n=25 Participants
Participant receives placebo 30 minutes prior to a one-time 1000mg dose of extended-release niacin.
Maximum Flushing Severity Score
3.2 units on a scale
Standard Deviation 2.7
2.8 units on a scale
Standard Deviation 2.6
3.3 units on a scale
Standard Deviation 2.5
3.6 units on a scale
Standard Deviation 2.6

Adverse Events

Apple-pectin 2000mg

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Regular Non-enteric Coated Aspirin 325mg

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Apple Pectin + Aspirin

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Placebo Comparator

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Julie-Ann Dutton, MS, RD

University of Kansas Medical Center

Phone: (913) 588-4064

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place