Serum Magnesium and Vascular Calcification | NCT01293786

Studies
Serum Magnesium and Vascular Calcification

NCT01293786

Sponsor

Ramathibodi Hospital

Status

Completed

Last Update Posted

May 26, 2011Estimated

Enrollment

400Estimated

Phase

Not provided

Conditions

Vascular Calcification
Chronic Kidney Disease

Interventions

Not provided

Countries

Thailand

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2011

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 2011

Primary Completion Date

May 2011Actual

Completion Date

May 2011Actual

First Submitted Date

Feb 10, 2011

First Submission Date that Met QC Criteria

Feb 10, 2011

First Posted Date

Feb 11, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 25, 2011

Last Update Posted Date

May 26, 2011Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

400Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
The difference in vascular calcification score between KT and CKD		Baseline

Secondary Outcomes

Measure	Description	Time Frame
The association of serum magnesium with vascular calcification in KT		Baseline
The association of serum magnesium with vascular calcification in CKD		Baseline

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Sinee Disthabanchong, MD	Ramathibodi Hospital, Mahidol University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Faculty of Medicine, Ramathibodi Hospital, Mahidol University		Phayathai	Bangkok	10400	Thailand

Condition Browse Module

MeSH Terms

ID	Term
D061205	Vascular Calcification
D051436	Renal Insufficiency, Chronic

Ancestor Terms

ID	Term
D002114	Calcinosis
D002128	Calcium Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided