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
Recruitment status was Recruiting
Sponsor:
Ramathibodi Hospital
Information provided by:
Ramathibodi Hospital
ClinicalTrials.gov Identifier:
NCT01364688
First received: May 26, 2011
Last updated: May 31, 2011
Last verified: May 2011
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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
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 June 17, 2013