Preliminary Study of Safety and Efficacy of Policosanol

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00312923
Recruitment Status : Completed
First Posted : April 11, 2006
Results First Posted : July 15, 2013
Last Update Posted : July 26, 2013
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

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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

Reporting Groups
Treatment Group

20 mg daily of policosanol

Policosanol : 20 mg of policosanol in capsular form daily

Control Group Placebo : Two capsules of 10 mg of microcrystalline cellulose daily

Participant Flow:   Overall Study
    Treatment Group   Control Group
STARTED   28   26 
COMPLETED   19   20 

  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
54 eligible participants were randomized to the study arms. 39 participants completed the study. An intent-to-treat analysis was performed.

Reporting Groups
Treatment Group

20 mg daily of policosanol

Policosanol : 20 mg of policosanol in capsular form daily

Control Group Placebo : Two capsules of 10 mg of microcrystalline cellulose daily
Total Total of all reporting groups

Baseline Measures
   Treatment Group   Control Group   Total 
Overall Participants Analyzed 
[Units: Participants]
 28   26   54 
[Units: Participants]
<=18 years   0   0   0 
Between 18 and 65 years   28   26   54 
>=65 years   0   0   0 
[Units: Years]
Mean (Standard Deviation)
 44.6  (.54)   46.8  (6.56)   44.67  (6.04) 
[Units: Participants]
Female   7   8   15 
Male   21   18   39 
Region of Enrollment 
[Units: Participants]
United States   28   26   54 

  Outcome Measures

1.  Primary:   LDL Cholesterol   [ Time Frame: 12 weeks ]

2.  Secondary:   Triglycerides   [ Time Frame: 12 weeks ]

  Serious Adverse Events

  Other Adverse Events

  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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.

  More Information

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 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