- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01364688
Oral Alfacalcidol and Coronary Artery Calcification in Predialysis Chronic Kidney Disease
May 31, 2011 updated by: Ramathibodi Hospital
Randomized Control Trial of Oral Alfacalcidol and Coronary Artery Calcification in Predialysis Chronic Kidney Disease
Active vitamin D at therapeutic dose may prevent vascular calcification but in supraphysiologic dose may precipitate it.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
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
Enrollment (Anticipated)
80
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Sinee Disthabanchong, MD
- Phone Number: +6622011116
- Email: tesdb@mahidol.ac.th
Study Locations
-
-
Bangkok
-
Phayathai, Bangkok, Thailand, 10400
- Recruiting
- Faculty of Medicine, Ramathibodi Hospital, Mahidol University
-
Contact:
- Sinee Disthabanchong, MD
- Phone Number: +662011116
- Email: tesdb@mahidol.ac.th
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Treatment
oral alfacalcidol
|
Oral alfacalcidol 0.5 microgram per day
|
No Intervention: Control
No drug
|
no drug
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change in Coronary Artery Calcification
Time Frame: 6 months and 12 months
|
6 months and 12 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
May 1, 2011
Primary Completion (Anticipated)
November 1, 2012
Study Completion (Anticipated)
December 1, 2012
Study Registration Dates
First Submitted
May 26, 2011
First Submitted That Met QC Criteria
May 31, 2011
First Posted (Estimate)
June 2, 2011
Study Record Updates
Last Update Posted (Estimate)
June 2, 2011
Last Update Submitted That Met QC Criteria
May 31, 2011
Last Verified
May 1, 2011
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 25-05-2011
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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