Safety and Effects of Supplementation With Ergocalciferol on Erythropoietin Dosing in Hemodialysis Patients

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Dialysis Clinic, Inc.
ClinicalTrials.gov Identifier:
NCT01395823
First received: July 14, 2011
Last updated: February 15, 2016
Last verified: February 2016
Results First Received: January 8, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: End Stage Renal Disease
Interventions: Dietary Supplement: ergocalciferol supplementation
Other: 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
470 subjects were enrolled in the study; however 151 subjects did not make it to randomization due to EPO criteria not met n=45, did not meet other inclusion criteria n=57, no was reason provided n=49. Of the 319 subjects randomized, 43 had a baseline 25(OH)D >30. This analysis only pertains to the 276 subjects with a baseline 25(OH)D ≤30.

Reporting Groups
  Description
Ergocalciferol Supplementation ergocalciferol supplementation: 50,000 IU given either weekly; weekly for 3 months then monthly for 3 months; monthly
Placebo placebo: placebo pill given weekly, weekly for 3 months then monthly for 3 months; monthly

Participant Flow:   Overall Study
    Ergocalciferol Supplementation     Placebo  
STARTED     137     139  
COMPLETED     122     130  
NOT COMPLETED     15     9  
Death                 4                 4  
Physician Decision                 3                 1  
Lost to Follow-up                 1                 0  
Transplant                 1                 0  
GI symptoms                 1                 0  
Withdrawal by Subject                 5                 4  



  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
Ergocalciferol Supplementation ergocalciferol supplementation: 50,000 IU given either weekly; weekly for 3 months then monthly for 3 months; monthly
Placebo placebo: placebo pill given weekly, weekly for 3 months then monthly for 3 months; monthly
Total Total of all reporting groups

Baseline Measures
    Ergocalciferol Supplementation     Placebo     Total  
Number of Participants  
[units: participants]
  137     139     276  
Age  
[units: years]
Mean (Standard Deviation)
  61.4  (13.3)     60.8  (13.9)     61.1  (13.6)  
Gender  
[units: participants]
     
Female     67     58     125  
Male     70     81     151  
Race (NIH/OMB)  
[units: participants]
     
American Indian or Alaska Native     0     0     0  
Asian     8     7     15  
Native Hawaiian or Other Pacific Islander     0     0     0  
Black or African American     76     90     166  
White     51     41     92  
More than one race     0     0     0  
Unknown or Not Reported     2     1     3  
Region of Enrollment  
[units: participants]
     
United States     137     139     276  
25Vit D (ng/mL)  
[units: ng/mL]
Mean (Standard Deviation)
  16.0  (5.9)     16.9  (6.4)     16.4  (6.2)  
Epogen Dose, units/week  
[units: units/week]
Median (Inter-Quartile Range)
  5800  
  (2600 to 12200)  
  5400  
  (2400 to 11500)  
  5550  
  (2500 to 11900)  



  Outcome Measures

1.  Primary:   EPO Dose   [ Time Frame: Baseline, 6 months ]


  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:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Karen Majchrzak
Organization: Dialysis Clinic Inc
phone: 615-342-0483
e-mail: karen.majchrzak@dciinc.org



Responsible Party: Dialysis Clinic, Inc.
ClinicalTrials.gov Identifier: NCT01395823     History of Changes
Other Study ID Numbers: DCI-0002
Study First Received: July 14, 2011
Results First Received: January 8, 2016
Last Updated: February 15, 2016
Health Authority: United States: Institutional Review Board