Oral Alfacalcidol and Coronary Artery Calcification in Predialysis Chronic Kidney Disease

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2011 by Ramathibodi Hospital.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Ramathibodi Hospital
ClinicalTrials.gov Identifier:
NCT01364688
First received: May 26, 2011
Last updated: May 31, 2011
Last verified: May 2011
  Purpose

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


Condition Intervention Phase
Vascular Calcification
Drug: oral alfacalcidol
Drug: no drug
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Randomized Control Trial of Oral Alfacalcidol and Coronary Artery Calcification in Predialysis Chronic Kidney Disease

Resource links provided by NLM:


Further study details as provided by Ramathibodi Hospital:

Primary Outcome Measures:
  • Change in Coronary Artery Calcification [ Time Frame: 6 months and 12 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 80
Study Start Date: May 2011
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Treatment
oral alfacalcidol
Drug: oral alfacalcidol
Oral alfacalcidol 0.5 microgram per day
No Intervention: Control
No drug
Drug: no drug
no drug

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

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
Study First Received: May 26, 2011
Last Updated: May 31, 2011
Health Authority: Thailand: Mahidol University

Keywords provided by Ramathibodi Hospital:
coronary calcification
vascular calcification
active vitamin D
alfacalcidol

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

ClinicalTrials.gov processed this record on July 29, 2014