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

NCT00285467 | Completed Results DMC

• 1 other identifier: 0508-06
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 1

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.

Conditions

Renal Osteodystrophy

Keywords

kidney, parathyroid hormone, vitamin d

Outcome Measures

Primary Outcomes (1)

• Percent Reduction in PTH

  Percent reduction in PTH from baseline to 3 months

  3 month

Secondary Outcomes (1)

• Systolic Blood Pressure at 3 Months

  3 month

Study Arms (2)

Doxercalciferol

EXPERIMENTAL

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.

Drug: doxercalciferol

Cholecalciferol

ACTIVE COMPARATOR

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.

Drug: Cholecalciferol

Interventions

doxercalciferol DRUG

form of vitamin D that is already in active form.

Also known as: Hectoral

Doxercalciferol

Cholecalciferol DRUG

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

Also known as: vitamin D3

Cholecalciferol

Eligibility Criteria

• Age: 18 Years - 82 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Indiana University School of Medicine: lead

Study Sites (1)

Indiana University School of Medicine

Indianapolis, Indiana, 46202, United States

Location

Related Publications (1)

• 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.

  PMID: 20056760 RESULT

MeSH Terms

Conditions

Chronic Kidney Disease-Mineral and Bone Disorder

Interventions

1 alpha-hydroxyergocalciferol; Cholecalciferol

Condition Hierarchy (Ancestors)

Rickets; Bone Diseases, Metabolic; Bone Diseases; Musculoskeletal Diseases; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases; Calcium Metabolism Disorders; Vitamin D Deficiency; Avitaminosis; Deficiency Diseases; Malnutrition; Nutrition Disorders; Hyperparathyroidism, Secondary; Hyperparathyroidism; Parathyroid Diseases; Endocrine System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cholestenes; Cholestanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Sterols; Vitamin D; Secosteroids; Membrane Lipids; Lipids

Limitations and Caveats

Larger, long term studies are needed to demonstrate efficacy of mineral-related and non-mineral-related endpoints and safety.

Results Point of Contact

• Title: Sharon Moe, MD
• Organization: Indiana University School of Medicine

smoe@iupui.edu

317-278-2868

Study Officials

• Sharon Moe, MD

  Indiana University School of Medicine

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 31, 2006
• First Posted: February 2, 2006
• Study Start: January 1, 2006
• Primary Completion: December 1, 2009
• Study Completion: December 1, 2009
• Last Updated: May 2, 2016
• Results First Posted: May 2, 2016

Record last verified: 2016-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)