Clinical trial NCT00285467: Cholecalciferol Versus Doxercalciferol in the Treatment of Secondary Hyperparathyroidism in Chronic Kidney Disease
Official title: Comparison of Cholecalciferol Versus Doxercalciferol in the Treatment of Secondary Hyperparathyroidism in CKD
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Renal Osteodystrophy
Keywords: kidney, parathyroid hormone, vitamin d
Lead sponsor: Indiana University
Sponsor class: OTHER
First posted: 2006-02-02
Enrollment: 55
Sex: ALL
Minimum age (years): 18
Maximum age (years): 82
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Percent Reduction in PTH
timeFrame: 3 month
Secondary outcomes:
measure: Systolic Blood Pressure at 3 Months
timeFrame: 3 month
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: Indiana University School of Medicine
state: Indiana
Study officials:
affiliation: Indiana University School of Medicine
name: Sharon Moe, MD
role: STUDY_DIRECTOR
References:
citation: 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.