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Effect of Niacin on Transport of HDL and Relationship to Atherogenic Lipoproteins and Lipolysis (ENTHRALL)

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ClinicalTrials.gov Identifier: NCT01250990
Recruitment Status : Completed
First Posted : December 1, 2010
Results First Posted : June 24, 2016
Last Update Posted : July 28, 2016
Sponsor:
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Richard Dunbar, University of Pennsylvania

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Basic Science
Condition Dyslipidemias
Interventions Drug: Niacin
Other: Placebo
Enrollment 22
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Niacin Placebo
Hide Arm/Group Description

Niacin taken orally for 12 weeks at the highest tolerated dose (up to 6 grams), and at least 2 grams daily and up to the maximum approved dose. Subjects will initiate therapy with Niaspan and will advance to Niacor as tolerated.

Niacin: Niacin taken orally for 12 weeks at the highest tolerated dose (up to 6 grams), and at least 2 grams daily and up to the maximum approved dose. Subjects will initiate therapy with Niaspan and will advance to Niacor as tolerated.

Placebo tablet with 50 mg niacin for the first 4 weeks to maintain blinding of the study team and subjects, changed to pure placebo after that.

Placebo: Placebo

Period Title: Overall Study
Started 11 11
Completed 7 9
Not Completed 4 2
Arm/Group Title Niacin Placebo Total
Hide Arm/Group Description

Niacin taken orally for 12 weeks at the highest tolerated dose (up to 6 grams), and at least 2 grams daily and up to the maximum approved dose. Subjects will initiate therapy with Niaspan and will advance to Niacor as tolerated.

Niacin: Niacin taken orally for 12 weeks at the highest tolerated dose (up to 6 grams), and at least 2 grams daily and up to the maximum approved dose. Subjects will initiate therapy with Niaspan and will advance to Niacor as tolerated.

Placebo tablet with 50 mg niacin for the first 4 weeks to maintain blinding of the study team and subjects, changed to pure placebo after that.

Placebo: Placebo

Total of all reporting groups
Overall Number of Baseline Participants 11 11 22
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 11 participants 11 participants 22 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
11
 100.0%
11
 100.0%
22
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 11 participants 11 participants 22 participants
Female
0
   0.0%
0
   0.0%
0
   0.0%
Male
11
 100.0%
11
 100.0%
22
 100.0%
1.Primary Outcome
Title Rate of Appearance of 3H Cholesterol in the Total HDL Fraction Before and After 12 Weeks of Treatment With Niacin
Hide Description Subjects were injected with a bolus of 3-H cholesterol mixed with human serum albumin as an intravenous bolus. This injected labelled cholesterol is taken up by macrophages. The rate of appearance of labelled cholesterol in plasma HDL- cholesterol is a measure of reverse cholesterol transport. We assessed HDL cholesterol enrichment as percent of injected tritiated tracer appearing in plasma total HDL cholesterol between 60 and 240 minutes post-injection expressed as percent 3-H cholesterol/mol HDL cholesterol/hour. The tracer study was performed at baseline and after 12 weeks of niacin or placebo.
Time Frame Baseline and 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Of the 22 subjects enrolled, only subjects who completed the baseline and 12 week reverse cholesterol transport studies were included in the final outcome analysis.
Arm/Group Title Niacin Placebo
Hide Arm/Group Description:

Niacin taken orally for 12 weeks at the highest tolerated dose (up to 6 grams), and at least 2 grams daily and up to the maximum approved dose. Subjects will initiate therapy with Niaspan and will advance to Niacor as tolerated.

Niacin: Niacin taken orally for 12 weeks at the highest tolerated dose (up to 6 grams), and at least 2 grams daily and up to the maximum approved dose. Subjects will initiate therapy with Niaspan and will advance to Niacor as tolerated.

Placebo tablet with 50 mg niacin for the first 4 weeks to maintain blinding of the study team and subjects, changed to pure placebo after that.

Placebo: Placebo

Overall Number of Participants Analyzed 7 9
Mean (95% Confidence Interval)
Unit of Measure: %/mol/h
Pre-treatment
3.24
(2.22 to 4.26)
4.16
(3.20 to 5.12)
Post-treatment
2.61
(1.59 to 3.63)
3.72
(2.76 to 4.67)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Niacin, Placebo
Comments This is a pilot study to assess the effects of niacin on reverse cholesterol transport. The null hypothesis is that niacin has no effect on reverse cholesterol transport.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.8
Comments p value is for comparison between changes in reverse cholesterol transport in niacin versus placebo groups after 12 weeks of treatment.
Method t-test, 2 sided
Comments [Not Specified]
Time Frame 6 months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Niacin Placebo
Hide Arm/Group Description

Niacin taken orally for 12 weeks at the highest tolerated dose (up to 6 grams), and at least 2 grams daily and up to the maximum approved dose. Subjects will initiate therapy with Niaspan and will advance to Niacor as tolerated.

Niacin: Niacin taken orally for 12 weeks at the highest tolerated dose (up to 6 grams), and at least 2 grams daily and up to the maximum approved dose. Subjects will initiate therapy with Niaspan and will advance to Niacor as tolerated.

Placebo tablet with 50 mg niacin for the first 4 weeks to maintain blinding of the study team and subjects, changed to pure placebo after that.

Placebo: Placebo

All-Cause Mortality
Niacin Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Hide Serious Adverse Events
Niacin Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/11 (0.00%)   0/11 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Niacin Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/11 (0.00%)   0/11 (0.00%) 
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: Richard L Dunbar
Organization: University of Pennsylvania
Phone: 215-662-9024
EMail: richard.dunbar@uphs.upenn.edu
Layout table for additonal information
Responsible Party: Richard Dunbar, University of Pennsylvania
ClinicalTrials.gov Identifier: NCT01250990    
Other Study ID Numbers: 811956
K23HL091130 ( U.S. NIH Grant/Contract )
First Submitted: November 29, 2010
First Posted: December 1, 2010
Results First Submitted: May 17, 2016
Results First Posted: June 24, 2016
Last Update Posted: July 28, 2016