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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00285467
First Posted: February 2, 2006
Last Update Posted: May 2, 2016
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.
Information provided by (Responsible Party):
Indiana University ( Indiana University School of Medicine )
January 31, 2006
February 2, 2006
March 27, 2012
May 2, 2016
May 2, 2016
January 2006
December 2009   (Final data collection date for primary outcome measure)
Percent Reduction in PTH [ Time Frame: 3 month ]
Percent reduction in PTH from baseline to 3 months
Percent Reduction in PTH
Complete list of historical versions of study NCT00285467 on ClinicalTrials.gov Archive Site
Systolic Blood Pressure at 3 Months [ Time Frame: 3 month ]
systolic blood pressure at 3 months
effect on blood pressure, pain and general well being
Not Provided
Not Provided
 
Cholecalciferol Versus Doxercalciferol in the Treatment of Secondary Hyperparathyroidism in Chronic Kidney Disease
Comparison of Cholecalciferol Versus Doxercalciferol in the Treatment of Secondary Hyperparathyroidism in CKD
The majority of patients with moderate to severe chronic kidney disease (CKD) (stages 3 and 4) develop secondary hyperparathyroidism (2°HPT), but the optimal therapy to control hyperparathyroidism in this group is unknown. The National Kidney Foundation presented guidelines in 2003 recommending vitamin D supplementation for vitamin D insufficient patients and active vitamin D therapy in patients with sufficient levels. These guidelines are based on opinion since there are no significant trials to determine if vitamin D supplementation is effective in this population. The active vitamin D metabolites doxercalciferol, paricalcitol, and calcitriol have been shown to effectively suppress parathyroid hormone (PTH), but have not been compared with vitamin D supplementation with a calciferol (ergocalciferol or cholecalciferol). Beyond hyperparathyroidism, small studies suggest vitamin D replacement in vitamin D insufficient non-CKD subjects result in improved pain, feeling of well being, blood pressure and strength. In this proposed study we wish to directly compare the effectiveness of cholecalciferol versus doxercalciferol in suppressing elevated PTH levels in subjects with CKD not on dialysis who have vitamin D insufficiency in a three month study. Secondary endpoints will be change in blood pressure.
Patients with CKD stage 3 were randomly allocated (by blinded group allocation) to either cholecalciferol (4000 U per day for one month then 2000 IU daily thereafter) or doxercalciferol (2.5 mcg po daily. Assessments for blood endpoints (primary end point PTH; secondary calcium, phosphorus) were done monthly. Other assessments (blood pressure) were done at baseline and at 3 months.
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Renal Osteodystrophy
  • Drug: doxercalciferol
    form of vitamin D that is already in active form.
    Other Name: Hectoral
  • Drug: Cholecalciferol
    from of vitamin D that requires cells in the body to make active
    Other Name: vitamin D3
  • Experimental: Doxercalciferol
    doxercalciferol 1 mcg capsule orally daily for 3 months. This is a form of vitamin D that does not require activation by enzymes in the liver and kidney.
    Intervention: Drug: doxercalciferol
  • Active Comparator: Cholecalciferol
    cholecalciferol 4000 IU capsule orally daily for one month, then 2000 IU capsule daily orally for 2 months. this form of vitamin D requires activation by cells of the body.
    Intervention: Drug: Cholecalciferol
Moe SM, Saifullah A, LaClair RE, Usman SA, Yu Z. A randomized trial of cholecalciferol versus doxercalciferol for lowering parathyroid hormone in chronic kidney disease. Clin J Am Soc Nephrol. 2010 Feb;5(2):299-306. doi: 10.2215/CJN.07131009. Epub 2010 Jan 7.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
55
December 2009
December 2009   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • age 18 years old or older, male or female
  • able to sign informed consent
  • CKD stage 3 (GFR 30-59 ml/min) or stage 4 (15-29 ml/min)
  • intact Parathyroid hormone level (iPTH) > 100 pg/ml for stage 3 or iPTH > 150 pg/ml for stage 4
  • calcidiol levels ≤ 20 ng/ml
  • ability to ambulate without assistance

Exclusion Criteria:

  • intact PTH > 400 pg/ml
  • initial corrected Calcium > 9.7 mg/dl
  • initial serum Phosphorous > 5.0 mg/dl
  • initial standardized blood pressure of > 160/100
  • history of significant liver disease or cirrhosis
  • anticipated requirement for dialysis in 6 months
  • malabsorption, severe chronic diarrhea, or ileostomy
  • no calcimimetic or active vitamin D therapy 30 days prior to enrollment
  • use of digoxin, magnesium containing products, mineral oil, or cholestyramine
Sexes Eligible for Study: All
18 Years to 82 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00285467
0508-06
Yes
Not Provided
Plan to Share IPD: No
Indiana University ( Indiana University School of Medicine )
Indiana University School of Medicine
Not Provided
Study Director: Sharon Moe, MD Indiana University School of Medicine
Indiana University
April 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP