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Serum Magnesium and Vascular Calcification

Sponsor
Ramathibodi Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT01293786
Collaborator
(none)
400
Enrollment
1
Location
2.9
Duration (Months)
136.8
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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 or Disease Intervention/Treatment Phase

    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 Design

    Study Type:
    Observational
    Anticipated Enrollment :
    400 participants
    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
    Study Start Date :
    Feb 1, 2011
    Actual Primary Completion Date :
    May 1, 2011
    Actual Study Completion Date :
    May 1, 2011

    Arms and Interventions

    Arm Intervention/Treatment
    Kidney transplant recipients
    Chronic kidney disease

    Outcome Measures

    Primary Outcome Measures

    1. The difference in vascular calcification score between KT and CKD [Baseline]

    Secondary Outcome Measures

    1. The association of serum magnesium with vascular calcification in KT [Baseline]

    2. The association of serum magnesium with vascular calcification in CKD [Baseline]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Locations

    Site City State Country Postal Code
    1 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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT01293786
    Other Study ID Numbers:
    • 03-02-2011
    First Posted:
    Feb 11, 2011
    Last Update Posted:
    May 26, 2011
    Last Verified:
    May 1, 2011
    Keywords provided by , ,
    magnesium
    kidney transplantation
    hypomagnesemia
    Additional relevant MeSH terms:
    Kidney Diseases
    Renal Insufficiency, Chronic
    Calcinosis
    Vascular Calcification

    Study Results

    No Results Posted as of May 26, 2011