Serum Magnesium and Vascular Calcification

This study has been completed.
Sponsor:
Information provided by:
Ramathibodi Hospital
ClinicalTrials.gov Identifier:
NCT01293786
First received: February 10, 2011
Last updated: May 25, 2011
Last verified: May 2011
  Purpose

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.


Condition
Vascular Calcification
Chronic Kidney Disease

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Cross-Sectional
Official Title: Comparison of Vascular Calcification Between Kidney Transplant Recipients and Predialysis Chronic Kidney Disease and Its Association With Serum Magnesium

Resource links provided by NLM:


Further study details as provided by Ramathibodi Hospital:

Primary Outcome Measures:
  • The difference in vascular calcification score between KT and CKD [ Time Frame: Baseline ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The association of serum magnesium with vascular calcification in KT [ Time Frame: Baseline ] [ Designated as safety issue: No ]
  • The association of serum magnesium with vascular calcification in CKD [ Time Frame: Baseline ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples Without DNA

serum


Estimated Enrollment: 400
Study Start Date: February 2011
Study Completion Date: May 2011
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
Kidney transplant recipients
Chronic kidney disease

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Kidney transplant recipients and predialysis chronic kidney disease patients from outpatient nephrology clinic of Ramathibodi hospital, Mahidol University

Criteria

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
  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: NCT01293786

Locations
Thailand
Faculty of Medicine, Ramathibodi Hospital, Mahidol University
Phayathai, Bangkok, Thailand, 10400
Sponsors and Collaborators
Ramathibodi Hospital
Investigators
Principal Investigator: Sinee Disthabanchong, MD Ramathibodi Hospital, Mahidol University
  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: NCT01293786     History of Changes
Other Study ID Numbers: 03-02-2011
Study First Received: February 10, 2011
Last Updated: May 25, 2011
Health Authority: Thailand: Mahidol University

Keywords provided by Ramathibodi Hospital:
magnesium
kidney transplantation
hypomagnesemia

Additional relevant MeSH terms:
Kidney Diseases
Renal Insufficiency, Chronic
Calcinosis
Vascular Calcification
Urologic Diseases
Renal Insufficiency
Calcium Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on October 02, 2014