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

NCT ID: NCT00285467

Last Updated: 2016-05-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 55 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-01-31
• Study Completion Date: 2009-12-31

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.

Conditions

Renal Osteodystrophy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: EXPERIMENTAL

doxercalciferol

Intervention Type: DRUG

form of vitamin D that is already in active form.

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.

Group Type: ACTIVE_COMPARATOR

Cholecalciferol

Intervention Type: DRUG

from of vitamin D that requires cells in the body to make active

Interventions

doxercalciferol

form of vitamin D that is already in active form.

Intervention Type: DRUG

Cholecalciferol

from of vitamin D that requires cells in the body to make active

Intervention Type: DRUG

Other Intervention Names

Hectoral; vitamin D3

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 82 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Indiana University School of Medicine

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sharon Moe, MD

Role: STUDY_DIRECTOR

Indiana University School of Medicine

Locations

Indiana University School of Medicine

Indianapolis, Indiana, United States

Countries

United States

References

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.

Reference Type: RESULT

PMID: 20056760 (View on PubMed)

Other Identifiers

0508-06

Identifier Type: -

Identifier Source: org_study_id