Preliminary Study of Safety and Efficacy of Policosanol

This study has been completed.
National Center for Complementary and Integrative Health (NCCIH)
Information provided by (Responsible Party):
Barbara Swanson, Rush University Medical Center Identifier:
First received: April 7, 2006
Last updated: July 19, 2013
Last verified: July 2013
Results First Received: May 23, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Crossover Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Treatment
Conditions: Dyslipidemia
HIV Infections
Interventions: Drug: Policosanol
Dietary Supplement: Placebo

  Participant Flow

  Baseline Characteristics
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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  
Number of Participants  
[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
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1.  Primary:   LDL Cholesterol   [ Time Frame: 12 weeks ]

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

  Serious Adverse Events

  Other Adverse Events

  Limitations and Caveats
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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
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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 ( US NIH Grant/Contract Award Number )
Study First Received: April 7, 2006
Results First Received: May 23, 2013
Last Updated: July 19, 2013
Health Authority: United States: Federal Government
United States: Food and Drug Administration