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Evaluation of Oral Alpha-Cyclodextrin for Decreasing Serum Cholesterol

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01131299
First Posted: May 26, 2010
Last Update Posted: October 21, 2016
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.
Information provided by (Responsible Party):
Marcelo Amar, M.D., National Institutes of Health Clinical Center (CC)
Results First Submitted: April 18, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition: Cardiovascular Disease
Interventions: Other: Placebo
Drug: Alpha cyclodextrin

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
The recruitment occurred at the Clinical Center, NIH.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
103 screened participants, 75 completed the study, 14 subject withdrawals and 14 subjects who did not meet inclusion criteria

Reporting Groups
  Description
Placebo First, Then Alpha Cyclodextrin

Randomized subjects will receive placebo 2 tablets orally (three times a day) for 12-14 weeks. After a one-week washout, the subjects will receive alpha cyclodextrin.

Alpha cyclodextrin: 2 tablets PO 3 times a day for 12-14 weeks

Alpha Cyclodextrin First, Then Placebo

Subjects will receive alpha cyclodextrin: 2 tablets PO 3 times a day for 12-14 weeks. After a one-week washout, the subjects will receive placebo.

Subjects will receive placebo 2 tablets orally (three times a day) for 12-14 weeks


Participant Flow:   Overall Study
    Placebo First, Then Alpha Cyclodextrin   Alpha Cyclodextrin First, Then Placebo
STARTED   42   44 
COMPLETED   38   37 
NOT COMPLETED   4   7 
Withdrawal by Subject                4                7 



  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.
No text entered.

Reporting Groups
  Description
Alpha Cyclodextrin & Placebo Participants

Randomized subjects receiving alpha cyclodextrin

Alpha cyclodextrin: 2 g PO 3 times a day for 12- 14 weeks

Randomized subjects receiving placebo comparator

Placebo: 2 tablets PO 3 times a day for 12-14 weeks


Baseline Measures
   Alpha Cyclodextrin & Placebo Participants 
Overall Participants Analyzed 
[Units: Participants]
 103 
Age 
[Units: Participants]
 
<=18 years   2 
Between 18 and 65 years   99 
>=65 years   2 
Gender 
[Units: Participants]
 
Female   60 
Male   43 
Region of Enrollment 
[Units: Participants]
 
United States   103 


  Outcome Measures
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1.  Primary:   Total Serum Cholesterol Levels for Alpha-cyclodextrin (a-CD) and Placebo Groups After 12-14 Weeks, Compared to Baseline   [ Time Frame: 24-28 weeks ]

2.  Secondary:   Small LDL Particle Number (by NMR Spectrometry of Lipoproteins) After 12-14 Weeks Intervention, Compared to Baseline for Alpha-cyclodextrin (a-CD) and Placebo Groups After 12-14 Weeks, Compared to Baseline   [ Time Frame: 24-28 weeks ]

3.  Secondary:   Serum Glucose Levels After 12-14 Weeks Intervention, Compared to Baseline for Alpha-cyclodextrin (a-CD) and Placebo Groups After 12-14 Weeks, Compared to Baseline   [ Time Frame: 24-28 weeks ]

4.  Secondary:   Lipoprotein Insulin Resistance Index (LIRI) After 12-14 Weeks Intervention, Compared to Baseline for Alpha-cyclodextrin (a-CD) and Placebo Groups After 12-14 Weeks, Compared to Baseline   [ Time Frame: 24-28 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
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Dr. Marcelo Amar
Organization: NIH NHLBI
phone: 301-402-0521
e-mail: mamar@mail.nih.gov


Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Marcelo Amar, M.D., National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier: NCT01131299     History of Changes
Other Study ID Numbers: 100088
10-H-0088 ( Other Identifier: NIH NHLBI )
First Submitted: May 25, 2010
First Posted: May 26, 2010
Results First Submitted: April 18, 2016
Results First Posted: October 21, 2016
Last Update Posted: October 21, 2016