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A Study of Oral Ergocalciferol to Treat Pruritis in Hemodialysis Patients (CRN11)

This study has been completed.
Sponsor:
Collaborator:
National Kidney Foundation
Information provided by (Responsible Party):
Mary Schanler, Winthrop University Hospital
ClinicalTrials.gov Identifier:
NCT01114672
First received: April 29, 2010
Last updated: February 15, 2013
Last verified: February 2013
Results First Received: January 8, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Treatment
Condition: Pruritis
Interventions: Drug: 50,000 Units Ergocalciferol
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
Adult patients undergoing maintenance hemodialysis were recruited from two hemodialysis facilities from 8/11/2010 to 8/1/2011.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Three patients failed the screening process due to exclusion criteria: One patient had PTH<70 pg/mL and two patients had serum phosphorus >7.0 mg/dL.

Reporting Groups
  Description
Ergocalciferol Patients in the Ergocalciferol Arm/Group received 50,000 international units of oral Ergocalciferol once a week for a study period of 12 weeks.
Oral Placebo Patients in the oral placebo Arm/Group received a placebo pill once a week for a period of 12 weeks.

Participant Flow:   Overall Study
    Ergocalciferol   Oral Placebo
STARTED   25   25 
COMPLETED   21   23 
NOT COMPLETED   4   2 
Death                0                1 
Withdrawal by Subject                2                1 
Lost to Follow-up                1                0 
transplanted                1                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
Ergocalciferol Patients in the Ergocalciferol Arm/Group received 50,000 international units of oral Ergocalciferol once a week for a study period of 12 weeks.
Oral Placebo Patients in the oral placebo Arm/Group received a placebo pill once a week for a period of 12 weeks.
Total Total of all reporting groups

Baseline Measures
   Ergocalciferol   Oral Placebo   Total 
Overall Participants Analyzed 
[Units: Participants]
 25   25   50 
Age 
[Units: Participants]
     
<=18 years   0   0   0 
Between 18 and 65 years   11   13   24 
>=65 years   14   12   26 
Age 
[Units: Years]
Mean (Standard Deviation)
 66.1  (14.7)   66.2  (13.7)   66.2  (15.6) 
Gender 
[Units: Participants]
     
Female   10   11   21 
Male   15   14   29 
Region of Enrollment 
[Units: Participants]
     
United States   25   25   50 


  Outcome Measures

1.  Primary:   Severity of Pruritis   [ Time Frame: Baseline and end of study (up to 12 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
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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 NOT 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.


Results Point of Contact:  
Name/Title: Mary Schanler, Principal Investigator
Organization: Winthrop University Hospital
phone: 5156639028
e-mail: mschanler@winthrop.org


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

Responsible Party: Mary Schanler, Winthrop University Hospital
ClinicalTrials.gov Identifier: NCT01114672     History of Changes
Other Study ID Numbers: 10020
Study First Received: April 29, 2010
Results First Received: January 8, 2013
Last Updated: February 15, 2013
Health Authority: United States: Institutional Review Board