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Vitamin D and Arteriovenous Fistulae

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.
ClinicalTrials.gov Identifier: NCT00912782
Recruitment Status : Completed
First Posted : June 3, 2009
Results First Posted : July 2, 2014
Last Update Posted : July 2, 2014
Information provided by (Responsible Party):

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: End-stage Renal Disease
Interventions: Drug: Vitamin D3
Drug: 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
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
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 
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

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
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 
Overall Participants Analyzed 
[Units: Participants]
 27   25   52 
[Units: Years]
Mean (Standard Deviation)
 52.1  (14.9)   49.9  (10.9)   51.1  (13.2) 
[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

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

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

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

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

Responsible Party: Monnie Wasse MD, MPH, FASN, Emory University
ClinicalTrials.gov Identifier: NCT00912782     History of Changes
Other Study ID Numbers: IRB00014859
First Submitted: June 1, 2009
First Posted: June 3, 2009
Results First Submitted: November 2, 2013
Results First Posted: July 2, 2014
Last Update Posted: July 2, 2014