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Preliminary Study of Safety and Efficacy of Policosanol

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ClinicalTrials.gov Identifier: NCT00312923
Recruitment Status : Completed
First Posted : April 11, 2006
Results First Posted : July 15, 2013
Last Update Posted : July 26, 2013
Sponsor:
Collaborator:
National Center for Complementary and Integrative Health (NCCIH)
Information provided by (Responsible Party):
Barbara Swanson, Rush University Medical Center

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Conditions Dyslipidemia
HIV Infections
Interventions Drug: Policosanol
Dietary Supplement: Placebo
Enrollment 54
Recruitment Details The study was conducted between April, 2006 and July, 2009 at three inner-city outpatient HIV/AIDS clinics located in a Chicago neighborhood that has been designated as medically underserved by the Health Resources Service Administration (HRSA).
Pre-assignment Details A total of 176 participants were screened for eligibility and 54 were randomized and entered into the intent-to-treat analyses. Most of the ineligible participants did not meet the study’s lipid criteria
Arm/Group Title Treatment Group Control Group
Hide Arm/Group Description

20 mg daily of policosanol

Policosanol : 20 mg of policosanol in capsular form daily

Placebo : Two capsules of 10 mg of microcrystalline cellulose daily
Period Title: Overall Study
Started 28 26
Completed 19 20
Not Completed 9 6
Arm/Group Title Treatment Group Control Group Total
Hide Arm/Group Description

20 mg daily of policosanol

Policosanol : 20 mg of policosanol in capsular form daily

Placebo : Two capsules of 10 mg of microcrystalline cellulose daily Total of all reporting groups
Overall Number of Baseline Participants 28 26 54
Hide Baseline Analysis Population Description
54 eligible participants were randomized to the study arms. 39 participants completed the study. An intent-to-treat analysis was performed.
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 28 participants 26 participants 54 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
28
 100.0%
26
 100.0%
54
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 28 participants 26 participants 54 participants
44.6  (.54) 46.8  (6.56) 44.67  (6.04)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 28 participants 26 participants 54 participants
Female
7
  25.0%
8
  30.8%
15
  27.8%
Male
21
  75.0%
18
  69.2%
39
  72.2%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 28 participants 26 participants 54 participants
28 26 54
1.Primary Outcome
Title LDL Cholesterol
Hide Description Low density lipoprotein cholesterol
Time Frame 12 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Treatment Group Control Group
Hide Arm/Group Description:

20 mg daily of policosanol

Policosanol : 20 mg of policosanol in capsular form daily

Placebo : Two capsules of 10 mg of microcrystalline cellulose daily
Overall Number of Participants Analyzed 27 27
Mean (Standard Deviation)
Unit of Measure: mg/dl
116.34  (37.75) 118.84  (38.38)
2.Secondary Outcome
Title Triglycerides
Hide Description [Not Specified]
Time Frame 12 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Treatment Group Control Group
Hide Arm/Group Description:

20 mg daily of policosanol

Policosanol : 20 mg of policosanol in capsular form daily

Placebo : Two capsules of 10 mg of microcrystalline cellulose daily
Overall Number of Participants Analyzed 27 27
Mean (Standard Deviation)
Unit of Measure: mg/dl
173.73  (200.39) 186.69  (125.60)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Treatment Group Control Group
Hide Arm/Group Description

20 mg daily of policosanol

Policosanol : 20 mg of policosanol in capsular form daily

Placebo : Two capsules of 10 mg of microcrystalline cellulose daily
All-Cause Mortality
Treatment Group Control Group
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Treatment Group Control Group
Affected / at Risk (%) Affected / at Risk (%)
Total   0/0   0/0 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Treatment Group Control Group
Affected / at Risk (%) Affected / at Risk (%)
Total   0/0   0/0 
It is possible that other constituents underlie policosanol’s lipid-lowering activity. One study found that triacontanol inhibited HMG-CoA reductase in rat liver cells. Triacontanol was not detected in either lot of policosanol used in this study.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Barbara Swanson
Organization: Rush University Medical Center
Phone: 312-942-8977
Responsible Party: Barbara Swanson, Rush University Medical Center
ClinicalTrials.gov Identifier: NCT00312923     History of Changes
Other Study ID Numbers: R21AT003077-01 ( U.S. NIH Grant/Contract )
R21AT003077-01 ( U.S. NIH Grant/Contract )
First Submitted: April 7, 2006
First Posted: April 11, 2006
Results First Submitted: May 23, 2013
Results First Posted: July 15, 2013
Last Update Posted: July 26, 2013