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

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ClinicalTrials.gov Identifier: NCT01093417
Recruitment Status : Completed
First Posted : March 25, 2010
Results First Posted : February 29, 2012
Last Update Posted : July 14, 2016
Sponsor:
Information provided by (Responsible Party):
Grace McComsey, University Hospitals Cleveland Medical Center

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Single Group Assignment;   Masking: Triple (Participant, Care Provider, Investigator)
Conditions: Human Immunodeficiency Virus (HIV)
Vitamin D Deficiency
HIV Infections
Interventions: Drug: Vitamin D
Other: 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
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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

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 
Overall Participants Analyzed 
[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

1.  Primary:   Change in Endothelial Function   [ Time Frame: Baseline and 12 weeks ]
  Show Outcome Measure 1

2.  Secondary:   Change in Serum 25-hydroxyvitamin D Concentration in Both Groups   [ Time Frame: Baseline and 12 weeks ]
  Show Outcome Measure 2


  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
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  More Information

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 Hospitals Cleveland Medical Center
ClinicalTrials.gov Identifier: NCT01093417     History of Changes
Other Study ID Numbers: 11-09-30
First Submitted: March 24, 2010
First Posted: March 25, 2010
Results First Submitted: January 28, 2012
Results First Posted: February 29, 2012
Last Update Posted: July 14, 2016