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Cholecalciferol Versus Doxercalciferol in the Treatment of Secondary Hyperparathyroidism in Chronic Kidney Disease

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ClinicalTrials.gov Identifier: NCT00285467
Recruitment Status : Completed
First Posted : February 2, 2006
Results First Posted : May 2, 2016
Last Update Posted : May 2, 2016
Sponsor:
Information provided by (Responsible Party):
Indiana University ( Indiana University School of Medicine )

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Renal Osteodystrophy
Interventions Drug: doxercalciferol
Drug: Cholecalciferol
Enrollment 55
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Doxercalciferol, Active Vitamin D Cholecalciferol, Inactive Vitamin D
Hide Arm/Group Description Doxercalciferol is an active Vitamin D readily usable by human body. Cholecalciferol is inactive Vitamin D and requires the kidneys to make it active.
Period Title: Overall Study
Started 25 22
Completed 25 22
Not Completed 0 0
Arm/Group Title Doxercalciferol, Active Vitamin D Cholecalciferol, Inactive Vitamin D Total
Hide Arm/Group Description Doxercalciferol is an active Vitamin D readily usable by human body. Cholecalciferol is inactive Vitamin D and requires the kidneys to make it active. Total of all reporting groups
Overall Number of Baseline Participants 25 22 47
Hide Baseline Analysis Population Description
47 subjects had at least one follow up visit after taking medications and were included in results.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 25 participants 22 participants 47 participants
65  (10) 62  (10) 63.5  (10)
Sex: Female, Male   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 25 participants 22 participants 47 participants
Female
9
  36.0%
12
  54.5%
21
  44.7%
Male
16
  64.0%
10
  45.5%
26
  55.3%
[1]
Measure Description: 55 subjects were consents and underwent qualifying blood tests. 47 subjects were randomized to treatment: 25 to doxercalciferol and 22 to cholecalciferol.
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 25 participants 22 participants 47 participants
25 22 47
1.Primary Outcome
Title Percent Reduction in PTH
Hide Description Percent reduction in PTH from baseline to 3 months
Time Frame 3 month
Hide Outcome Measure Data
Hide Analysis Population Description
The initial sample size was based on the published response to doxercalciferol versus placebo where a 46% reduction in PTH was observed over 6 months, with a 51% SD. The expected reduction in PTH with cholecalciferol was based on the best-case scenario decrease of 17.8% in PTH with ergocalciferol from our own clinic setting.
Arm/Group Title Doxercalciferol, Active Vitamin D Cholecalciferol, Inactive Vitamin D
Hide Arm/Group Description:
Doxercalciferol is an active Vitamin D readily usable by human body.
Cholecalciferol is inactive Vitamin D and requires the kidneys to make it active.
Overall Number of Participants Analyzed 25 22
Mean (Standard Deviation)
Unit of Measure: % change in PTH baseline to 3 months
27  (34) 10  (31)
2.Secondary Outcome
Title Systolic Blood Pressure at 3 Months
Hide Description systolic blood pressure at 3 months
Time Frame 3 month
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Doxercalciferol, Active Vitamin D Cholecalciferol, Inactive Vitamin D
Hide Arm/Group Description:
Doxercalciferol is an active Vitamin D readily usable by human body.
Cholecalciferol is inactive Vitamin D and requires the kidneys to make it active.
Overall Number of Participants Analyzed 25 22
Mean (Standard Deviation)
Unit of Measure: mmHg
120  (47) 128  (33)
Time Frame 4 months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Doxercalciferol, Active Vitamin D Cholecalciferol, Inactive Vitamin D
Hide Arm/Group Description Doxercalciferol is an active Vitamin D readily usable by human body. Cholecalciferol is inactive Vitamin D and requires the kidneys to make it active.
All-Cause Mortality
Doxercalciferol, Active Vitamin D Cholecalciferol, Inactive Vitamin D
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Hide Serious Adverse Events
Doxercalciferol, Active Vitamin D Cholecalciferol, Inactive Vitamin D
Affected / at Risk (%) Affected / at Risk (%)
Total   0/25 (0.00%)   0/22 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Doxercalciferol, Active Vitamin D Cholecalciferol, Inactive Vitamin D
Affected / at Risk (%) Affected / at Risk (%)
Total   0/25 (0.00%)   0/22 (0.00%) 
Larger, long term studies are needed to demonstrate efficacy of mineral-related and non-mineral-related endpoints and safety.
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
Layout table for Results Point of Contact information
Name/Title: Sharon Moe, MD
Organization: Indiana University School of Medicine
Phone: 317-278-2868
EMail: smoe@iupui.edu
Layout table for additonal information
Responsible Party: Indiana University ( Indiana University School of Medicine )
ClinicalTrials.gov Identifier: NCT00285467    
Other Study ID Numbers: 0508-06
First Submitted: January 31, 2006
First Posted: February 2, 2006
Results First Submitted: March 27, 2012
Results First Posted: May 2, 2016
Last Update Posted: May 2, 2016