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NCT Number: NCT00285467

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

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.

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Key information

Conditions

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

Age range

18 year–82 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Indiana University School of Medicine

Indianapolis, Indiana, 46202, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Doxercalciferol

Drug

form of vitamin D that is already in active form.

Other names: Hectoral

Cholecalciferol

Drug

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

Other names: vitamin D3

Primary outcomes

  1. Percent Reduction in PTH

    Time frame: 3 month

    Percent reduction in PTH from baseline to 3 months

Secondary outcomes

  1. Systolic Blood Pressure at 3 Months

    Time frame: 3 month

    systolic blood pressure at 3 months

Sponsors and collaborators

Lead sponsor

Indiana University

Other

Registry information

Official study title

Comparison of Cholecalciferol Versus Doxercalciferol in the Treatment of Secondary Hyperparathyroidism in CKD

Important dates

Study start
2006
Primary completion
2009
Study completion
2009
First posted
Feb 2, 2006
Registry last updated
May 2, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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