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Study of Vitamin D and Effect on Heart Disease and Insulin Resistance

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Grace McComsey, University Hospital Case Medical Center
ClinicalTrials.gov Identifier:
NCT01093417
First received: March 24, 2010
Last updated: June 14, 2016
Last verified: June 2016
History of Changes
Results First Received: January 28, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator)
Conditions: Human Immunodeficiency Virus (HIV)
Vitamin D Deficiency
HIV Infections
Interventions: Drug: Vitamin D
Other: Placebo

  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
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Placebo 15 participants were randomized to matching placebo for 12 weeks
Vitamin D 4000 IU 30 participants were randomized to 4000IU of cholecalciferol (vitamin D3) daily for 12 weeks

Participant Flow:   Overall Study
    Placebo     Vitamin D 4000 IU  
STARTED     15     30  
COMPLETED     15     29  
NOT COMPLETED     0     1  



  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.
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Reporting Groups
  Description
Placebo 15 participants were randomized to matching placebo for 12 weeks
Vitamin D 4000 IU 30 participants were randomized to 4000IU of cholecalciferol (vitamin D3) daily for 12 weeks
Total Total of all reporting groups

Baseline Measures
    Placebo     Vitamin D 4000 IU     Total  
Number of Participants  
[units: participants]
 		  15     30     45  
Age  
[units: participants]
 		     
<=18 years     0     0     0  
Between 18 and 65 years     15     30     45  
>=65 years     0     0     0  
Age  
[units: years]
Mean (Standard Deviation) 		  40  (10)     47  (8)     45  (9)  
Gender  
[units: participants]
 		     
Female     5     5     10  
Male     10     25     35  
Region of Enrollment  
[units: participants]
 		     
United States     15     30     45  



  Outcome Measures
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1.  Primary:   Change in Endothelial Function   [ Time Frame: Baseline and 12 weeks ]
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2.  Secondary:   Change in Serum 25-hydroxyvitamin D Concentration in Both Groups   [ Time Frame: Baseline and 12 weeks ]
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  Serious Adverse Events
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  Other Adverse Events
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  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: Grace McComsey, MD
Organization: University Hospitals Case Medical Center
phone: 2168443607
e-mail: gam9@case.edu


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


Responsible Party: Grace McComsey, University Hospital Case Medical Center
ClinicalTrials.gov Identifier: NCT01093417     History of Changes
Other Study ID Numbers: 11-09-30
Study First Received: March 24, 2010
Results First Received: January 28, 2012
Last Updated: June 14, 2016
Health Authority: USA:Internal Review Board