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Vitamin D Repletion in Chronic Kidney Disease

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00772772
First Posted: October 15, 2008
Last Update Posted: January 15, 2015
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):
Manish Ponda, Rockefeller University
Results First Submitted: March 10, 2011  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Chronic Kidney Disease
Intervention: Drug: Vitamin D3

  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
No text entered.

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
Vitamin D3 Vitamin D3 30,000 units PO weekly for 8 weeks

Participant Flow:   Overall Study
    Vitamin D3
STARTED   12 
COMPLETED   12 
NOT COMPLETED   0 



  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
Vitamin D3 No text entered.

Baseline Measures
   Vitamin D3 
Overall Participants Analyzed 
[Units: Participants]
 12 
Age 
[Units: Years]
Mean (Standard Deviation)
 61  (7) 
Gender 
[Units: Participants]
 
Female   6 
Male   6 
Region of Enrollment 
[Units: Participants]
 
United States   12 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Change in Endotoxin Activity   [ Time Frame: baseline and 8 weeks ]

2.  Secondary:   25-hydroxy Vitamin D (25-OH Vitamin D)   [ Time Frame: after 8 weeks of vitamin D therapy ]

3.  Secondary:   Blood Pressure   [ Time Frame: after 8 weeks of vitamin D therapy ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

4.  Secondary:   Intestinal Permeability   [ Time Frame: after 8 weeks of vitamin D therapy ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

5.  Secondary:   Nuclear Magnetic Resonance (NMR) Lipoprotein Profile   [ Time Frame: after 8 weeks of vitamin D therapy ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

6.  Secondary:   1, 25-OH Vitamin D   [ Time Frame: after 8 weeks of vitamin D therapy ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  


  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. Mansih Ponda
Organization: The Rockefeller University
phone: 212-327-7631
e-mail: mponda@rockefeller.edu



Responsible Party: Manish Ponda, Rockefeller University
ClinicalTrials.gov Identifier: NCT00772772     History of Changes
Other Study ID Numbers: MAP-0626
First Submitted: October 13, 2008
First Posted: October 15, 2008
Results First Submitted: March 10, 2011
Results First Posted: June 13, 2011
Last Update Posted: January 15, 2015