Magnesium Supplementation for Hypomagnesemia in Chronic Kidney Disease
Primary Purpose
Chronic Kidney Disease, Hypomagnesemia
Status
Completed
Phase
Phase 1
Locations
Denmark
Study Type
Interventional
Intervention
Mablet 360 mg
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Kidney Disease focused on measuring Chronic Kidney Disease, Hypomagnesemia
Eligibility Criteria
Inclusion Criteria:
- Estimated Glomerular filtration rate (eGFR) < 60 mL/min.
- Serum magnesium < 0.82 mmol/L.
- Written informed consent.
Exclusion Criteria:
- Hemodialysis.
- Peritoneal dialysis.
- Kidney transplant recipient.
- Parathyroid hormone > 600 pg/L.
- Pregnancy.
- Comorbidity that makes study participation and completion impossible.
Sites / Locations
- Department of Medicine, Division of Nephrology, Roskilde County Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Placebo Comparator
Experimental
Experimental
Arm Label
Placebo
Mablet 360 mg once daily
Mablet 360 mg twice daily
Arm Description
Oral placebo twice daily for 8 weeks. 12 subjects.
Oral Mablet 360 mg once daily and oral placebo once daily for 8 weeks. 12 subjects.
Oral Mablet 360 mg twice daily for 8 weeks. 12 subjects.
Outcomes
Primary Outcome Measures
Intracellular magnesium
Intracellular magnesium measured by energy dispersive x-ray analysis (www.exatest.com).
Secondary Outcome Measures
Total serum magnesium
Ionized serum magnesium
Full Information
NCT ID
NCT02216877
First Posted
August 12, 2014
Last Updated
April 27, 2015
Sponsor
Zealand University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT02216877
Brief Title
Magnesium Supplementation for Hypomagnesemia in Chronic Kidney Disease
Official Title
Magnesium Supplementation for Hypomagnesemia in Chronic Kidney Disease - A Dose-Finding Trial
Study Type
Interventional
2. Study Status
Record Verification Date
April 2015
Overall Recruitment Status
Completed
Study Start Date
August 2014 (undefined)
Primary Completion Date
April 2015 (Actual)
Study Completion Date
April 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Zealand University Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Randomized placebo-controlled interventional trial to investigate the effect of oral magnesium supplementation on intracellular magnesium in subjects with chronic kidney disease. We hypothesize that oral magnesium supplementation will increase intracellular magnesium in subjects with chronic kidney disease as well as increase serum magnesium.
Detailed Description
Chronic kidney disease (CKD) is associated with increase cardiovascular morbidity and mortality independent of traditional cardiovascular risk factors due to increased vascular calcification. Epidemiological and experimental data suggest that hypermagnesemia and magnesium supplementation reduce vascular calcification in chronic kidney disease by increasing calcium/phosphate solubility in serum, by inhibiting calcium influx into vascular smooth muscle cells (VSMC), by inhibiting intracellular pro-calcification enzymes in VSMC and by increasing activity of intracellular anti-calcification enzymes in VSMC. A trial to investigate the effect of oral magnesium supplementation on vascular calcification in subjects with CKD is currently being planned, but prior to initiating such a trial it is necessary to determine the dose of oral magnesium needed to increase intracellular magnesium and serum magnesium.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Kidney Disease, Hypomagnesemia
Keywords
Chronic Kidney Disease, Hypomagnesemia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
36 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Oral placebo twice daily for 8 weeks. 12 subjects.
Arm Title
Mablet 360 mg once daily
Arm Type
Experimental
Arm Description
Oral Mablet 360 mg once daily and oral placebo once daily for 8 weeks. 12 subjects.
Arm Title
Mablet 360 mg twice daily
Arm Type
Experimental
Arm Description
Oral Mablet 360 mg twice daily for 8 weeks. 12 subjects.
Intervention Type
Drug
Intervention Name(s)
Mablet 360 mg
Other Intervention Name(s)
Magnesium hydroxide
Intervention Type
Drug
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
Intracellular magnesium
Description
Intracellular magnesium measured by energy dispersive x-ray analysis (www.exatest.com).
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
Total serum magnesium
Time Frame
8 weeks
Title
Ionized serum magnesium
Time Frame
8 weeks
Other Pre-specified Outcome Measures:
Title
Markers of CKD-MBD (Chronic Kidney Disease - Mineral and Bone Disorder)
Description
Serum calcium, phosphate, parathyroid hormone (PTH), fibroblast growth factor 23 (FGF-23), 25-(OH)-hydroxy vitamin D, 1,25-(OH)-dihydroxy vitamin D as well as urine calcium and phosphate.
Time Frame
8 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Estimated Glomerular filtration rate (eGFR) < 60 mL/min.
Serum magnesium < 0.82 mmol/L.
Written informed consent.
Exclusion Criteria:
Hemodialysis.
Peritoneal dialysis.
Kidney transplant recipient.
Parathyroid hormone > 600 pg/L.
Pregnancy.
Comorbidity that makes study participation and completion impossible.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Iain B Bressendorff, MD
Organizational Affiliation
Department of Medicine, Division of Nephrology, Roskilde County Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Medicine, Division of Nephrology, Roskilde County Hospital
City
Roskilde
Country
Denmark
12. IPD Sharing Statement
Learn more about this trial
Magnesium Supplementation for Hypomagnesemia in Chronic Kidney Disease
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