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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

  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
  Description
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 
NOT COMPLETED   9   6 



  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
  Description
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 
Age 
[Units: Participants]
 		     
<=18 years   0   0   0 
Between 18 and 65 years   28   26   54 
>=65 years   0   0   0 
Age 
[Units: Years]
Mean (Standard Deviation) 		 44.6  (.54)   46.8  (6.56)   44.67  (6.04) 
Gender 
[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 ]
  Show Outcome Measure 1

2.  Secondary:   Triglycerides   [ Time Frame: 12 weeks ]
  Show Outcome Measure 2


  Serious Adverse Events


  Other Adverse Events

Time Frame No text entered.
Additional Description No text entered.

Frequency Threshold
Threshold above which other adverse events are reported   5%  

Reporting Groups
  Description
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

Other Adverse Events
    Treatment Group   Control Group
Total, Other (not including serious) Adverse Events     
# participants affected / at risk   0/0   0/0 



  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