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Vitamin D Repletion in Chronic Kidney Disease

This study has been completed.
Sponsor:
Information provided by:
Rockefeller University
ClinicalTrials.gov Identifier:
NCT00772772
First received: October 13, 2008
Last updated: May 11, 2011
Last verified: May 2011
Results First Received: March 10, 2011  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: 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 No text entered.

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.
No text entered.

Reporting Groups
  Description
Vitamin D3 No text entered.

Baseline Measures
    Vitamin D3  
Number of Participants  
[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.   Safety Issue:   No

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

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.   Safety Issue:   No

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.   Safety Issue:   No


  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


No publications provided


Responsible Party: Manish Ponda, MD, Rockefeller University
ClinicalTrials.gov Identifier: NCT00772772     History of Changes
Other Study ID Numbers: MAP-0626
Study First Received: October 13, 2008
Results First Received: March 10, 2011
Last Updated: May 11, 2011
Health Authority: United States: Institutional Review Board