- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01293786
Serum Magnesium and Vascular Calcification
May 25, 2011 updated by: Ramathibodi Hospital
Comparison of Vascular Calcification Between Kidney Transplant Recipients and Predialysis Chronic Kidney Disease and Its Association With Serum Magnesium
Both Kidney transplantation (KT) and Chronic Kidney Disease (CKD) patients have reduced kidney function.
Low serum magnesium is more prevalent in KT recipients.
The present study examines the difference in vascular calcification between KT and CKD and its association with serum magnesium.
Study Overview
Status
Completed
Conditions
Detailed Description
Kidney transplantation (KT) improved quality of life and longevity of CKD patients.
Nevertheless, kidney function deteriorates overtime in a manner not different from CKD counterparts.
Hypomagnesemia is prevalent in KT recipients secondary to immunosuppressive therapy.
In addition to serum calcium, phosphate and elemental calcium intake, the relationship between low serum magnesium and vascular calcification (VC) has been observed in small studies in CKD.
Whether low serum magnesium associates with VC in KT has never been elucidated.
The present study compares vascular calcification between KT and CKD and its association with serum magnesium.
Study Type
Observational
Enrollment (Anticipated)
400
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Bangkok
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Phayathai, Bangkok, Thailand, 10400
- Faculty of Medicine, Ramathibodi Hospital, Mahidol University
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-
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
Sampling Method
Probability Sample
Study Population
Kidney transplant recipients and predialysis chronic kidney disease patients from outpatient nephrology clinic of Ramathibodi hospital, Mahidol University
Description
Inclusion Criteria:
- kidney transplant recipients at least 1 year post surgery
- predialysis chronic kidney disease with serum creatinine > 1.1 mg/dL in female and 1.3 mg/dL in male
Exclusion Criteria:
- acute kidney injury
- parathyroidectomy
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
Cohorts and Interventions
Group / Cohort |
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Chronic kidney disease
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Kidney transplant recipients
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
The difference in vascular calcification score between KT and CKD
Time Frame: Baseline
|
Baseline
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
The association of serum magnesium with vascular calcification in KT
Time Frame: Baseline
|
Baseline
|
The association of serum magnesium with vascular calcification in CKD
Time Frame: Baseline
|
Baseline
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Sinee Disthabanchong, MD, Ramathibodi Hospital, Mahidol University
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
February 1, 2011
Primary Completion (Actual)
May 1, 2011
Study Completion (Actual)
May 1, 2011
Study Registration Dates
First Submitted
February 10, 2011
First Submitted That Met QC Criteria
February 10, 2011
First Posted (Estimate)
February 11, 2011
Study Record Updates
Last Update Posted (Estimate)
May 26, 2011
Last Update Submitted That Met QC Criteria
May 25, 2011
Last Verified
May 1, 2011
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 03-02-2011
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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