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Oral Alfacalcidol and Coronary Artery Calcification in Predialysis Chronic Kidney Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01364688
Recruitment Status : Unknown
Verified May 2011 by Ramathibodi Hospital.
Recruitment status was:  Recruiting
First Posted : June 2, 2011
Last Update Posted : June 2, 2011
Information provided by:
Ramathibodi Hospital

Brief Summary:
Active vitamin D at therapeutic dose may prevent vascular calcification but in supraphysiologic dose may precipitate it.

Condition or disease Intervention/treatment Phase
Vascular Calcification Drug: oral alfacalcidol Drug: no drug Phase 2

Detailed Description:
Active vitamin D compound is used frequently in the treatment of hyperparathyroidism in chronic kidney disease. Recent evidence from animal studies suggested that low dose of active vitamin D may be protective against vascular calcification, whereas high dose could precipitate it. The present study will examine the effect of low dose oral alfacalcidol on coronary artery calcification in predialysis chronic kidney disease patients with hyperparathyroidism.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Randomized Control Trial of Oral Alfacalcidol and Coronary Artery Calcification in Predialysis Chronic Kidney Disease
Study Start Date : May 2011
Estimated Primary Completion Date : November 2012
Estimated Study Completion Date : December 2012

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Treatment
oral alfacalcidol
Drug: oral alfacalcidol
Oral alfacalcidol 0.5 microgram per day

No Intervention: Control
No drug
Drug: no drug
no drug

Primary Outcome Measures :
  1. Change in Coronary Artery Calcification [ Time Frame: 6 months and 12 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Predialysis chronic kidney disease with GFR < 90 mL/min/1.73m2
  • PTH above the upper limit of normal
  • serum calcium and phosphate below the upper limit of normal

Exclusion Criteria:

  • changes in GFR>15% during the past 3 months
  • receive elemental calcium>500 mg/day
  • currently taking active vitamin D, oral calcium with elemental calcium>500 mg/day or bisphosphonate

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01364688

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Contact: Sinee Disthabanchong, MD +6622011116

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Faculty of Medicine, Ramathibodi Hospital, Mahidol University Recruiting
Phayathai, Bangkok, Thailand, 10400
Contact: Sinee Disthabanchong, MD    +662011116   
Sponsors and Collaborators
Ramathibodi Hospital
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Responsible Party: Sinee Disthabanchong, MD, Division of Nephrology, Department of Medicine, Faculty of Medicine, Ramathibodi Hospital, Mahidol University, Bangkok, Thailand Identifier: NCT01364688    
Other Study ID Numbers: 25-05-2011
First Posted: June 2, 2011    Key Record Dates
Last Update Posted: June 2, 2011
Last Verified: May 2011
Keywords provided by Ramathibodi Hospital:
coronary calcification
vascular calcification
active vitamin D
Additional relevant MeSH terms:
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Kidney Diseases
Renal Insufficiency, Chronic
Vascular Calcification
Urologic Diseases
Renal Insufficiency
Calcium Metabolism Disorders
Metabolic Diseases
Bone Density Conservation Agents
Physiological Effects of Drugs
Growth Substances