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Oral Alfacalcidol and Coronary Artery Calcification in Predialysis Chronic Kidney Disease

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ClinicalTrials.gov 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
Sponsor:
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.

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

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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 ]


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

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 ClinicalTrials.gov identifier (NCT number): NCT01364688


Contacts
Contact: Sinee Disthabanchong, MD +6622011116 tesdb@mahidol.ac.th

Locations
Thailand
Faculty of Medicine, Ramathibodi Hospital, Mahidol University Recruiting
Phayathai, Bangkok, Thailand, 10400
Contact: Sinee Disthabanchong, MD    +662011116    tesdb@mahidol.ac.th   
Sponsors and Collaborators
Ramathibodi Hospital

Responsible Party: Sinee Disthabanchong, MD, Division of Nephrology, Department of Medicine, Faculty of Medicine, Ramathibodi Hospital, Mahidol University, Bangkok, Thailand
ClinicalTrials.gov Identifier: NCT01364688     History of Changes
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
alfacalcidol

Additional relevant MeSH terms:
Kidney Diseases
Renal Insufficiency, Chronic
Calcinosis
Vascular Calcification
Coronary Artery Disease
Urologic Diseases
Renal Insufficiency
Calcium Metabolism Disorders
Metabolic Diseases
Coronary Disease
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Alfacalcidol
Hydroxycholecalciferols
Bone Density Conservation Agents
Physiological Effects of Drugs
Vitamins
Micronutrients
Growth Substances