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Comparison of Cholecalciferol Versus Doxercalciferol in the Treatment of Secondary Hyperparathyroidism in Chronic Kidney Disease Stage Three and Four

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Indiana University ( Indiana University School of Medicine )
ClinicalTrials.gov Identifier:
NCT00285467
First received: January 31, 2006
Last updated: October 12, 2011
Last verified: October 2011
History of Changes
  Purpose

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 muscle strength, blood pressure, renal function, and quality of life measures.


Condition Intervention
Secondary Hyperparathyroidism in Chronic Kidney Disease Stage 3 and 4
 Drug: doxercalciferol and cholecalciferol

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Comparison of Cholecalciferol Versus Doxercalciferol in the Treatment of Secondary Hyperparathyroidism in Chronic Kidney Disease Stage Three and Four

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Indiana University:

Primary Outcome Measures:
  • percent reduction in PTH [ Time Frame: 3 month ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • effect on blood pressure, pain and general well being [ Time Frame: 3 month ] [ Designated as safety issue: Yes ]

Enrollment: 58
Study Start Date: January 2006
Study Completion Date: December 2009
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
doxercalciferol, an active Vitamin D readily usable by human body
 Drug: doxercalciferol and cholecalciferol
subjects will be randomized to either doxercalciferol0.5mcg or cholecalciferol 2000u, one capsule daily for 3 months
Experimental: 2
cholecalciferol ( inactive Vitamin D that requires the kidneys to make it active)
 Drug: doxercalciferol and cholecalciferol
subjects will be randomized to either doxercalciferol0.5mcg or cholecalciferol 2000u, one capsule daily for 3 months

  Eligibility

Ages Eligible for Study:   18 Years to 82 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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)
  • 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00285467

Locations
United States, Indiana
Indiana University School of Medicine
Indianapolis, Indiana, United States, 46202
Sponsors and Collaborators
Indiana University School of Medicine
Investigators
Study Director: Sharon Moe, MD Indiana University School of Medicine
  More Information

Publications:

Responsible Party: Indiana University ( Indiana University School of Medicine )
ClinicalTrials.gov Identifier: NCT00285467     History of Changes
Other Study ID Numbers: 0508-06
Study First Received: January 31, 2006
Last Updated: October 12, 2011
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Hyperparathyroidism
Hyperparathyroidism, Secondary
Kidney Diseases
Renal Insufficiency, Chronic
Kidney Failure, Chronic
Parathyroid Diseases
Endocrine System Diseases
Urologic Diseases
Renal Insufficiency
 Cholecalciferol
1 alpha-hydroxyergocalciferol
Ergocalciferols
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Bone Density Conservation Agents

ClinicalTrials.gov processed this record on June 13, 2013