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Vitamin D and Arteriovenous Fistulae

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Monnie Wasse MD, MPH, FASN, Emory University
ClinicalTrials.gov Identifier:
NCT00912782
First received: June 1, 2009
Last updated: June 2, 2014
Last verified: June 2014
Results First Received: November 2, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: End-stage Renal Disease
Interventions: Drug: Vitamin D3
Drug: 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
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
107 Assessed for Eligibility with 55 Excluded for declining to participate (12), not meeting criteria (41), and other reasons (6) leaving 52 patients randomly assigned for the study. Some individuals were counted as having more than two reasons to be excluded from the study.

Reporting Groups
  Description
Placebo Placebo one time per week for 3 weeks
Cholecalciferol Vitamin D 200,000 IU per week for 3 weeks

Participant Flow:   Overall Study
    Placebo     Cholecalciferol  
STARTED     27     25  
COMPLETED     24     20  
NOT COMPLETED     3     5  
Death                 2                 1  
Lost to Follow-up                 0                 1  
Did not receive vascular access type                 1                 2  
Relocated before study completion                 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.
No text entered.

Reporting Groups
  Description
Placebo Placebo one time per week for 3 weeks
Cholecalciferol Vitamin D 200,000 IU per week for 3 weeks
Total Total of all reporting groups

Baseline Measures
    Placebo     Cholecalciferol     Total  
Number of Participants  
[units: participants]
  27     25     52  
Age  
[units: years]
Mean ± Standard Deviation
  52.1  ± 14.9     49.9  ± 10.9     51.1  ± 13.2  
Gender  
[units: participants]
     
Female     9     5     14  
Male     18     20     38  
Race (NIH/OMB)  
[units: participants]
     
American Indian or Alaska Native     0     0     0  
Asian     0     0     0  
Native Hawaiian or Other Pacific Islander     0     0     0  
Black or African American     21     19     40  
White     0     0     0  
More than one race     0     0     0  
Unknown or Not Reported     6     6     12  
Region of Enrollment  
[units: participants]
     
United States     27     25     52  



  Outcome Measures
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1.  Primary:   Arteriovenous Fistulae Maturation   [ Time Frame: 6 months ]

2.  Secondary:   25-hydroxyvitamin D and Serum Calcium   [ Time Frame: 10 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
No text entered.


  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: Monnie Wasse MD/MPH / Associate Professor of Medicine
Organization: Emory University
phone: 404-727-1598
e-mail: hwasse@emory.edu


No publications provided by Emory University

Publications automatically indexed to this study:

Responsible Party: Monnie Wasse MD, MPH, FASN, Emory University
ClinicalTrials.gov Identifier: NCT00912782     History of Changes
Other Study ID Numbers: IRB00014859
Study First Received: June 1, 2009
Results First Received: November 2, 2013
Last Updated: June 2, 2014
Health Authority: United States: Institutional Review Board