Magnesium Supplementation for Hypomagnesemia in Chronic Kidney Disease

Study Overview
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Brief Summary
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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
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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.

Official Title
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Magnesium Supplementation for Hypomagnesemia in Chronic Kidney Disease - A Dose-Finding Trial

Conditions
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Chronic Kidney Disease, Hypomagnesemia

Intervention / Treatment
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* Drug: Mablet 360 mg
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>Oral placebo twice daily for 8 weeks. 12 subjects. | Drug: Placebo<br> <br> |
| Experimental: Mablet 360 mg once daily<br>Oral Mablet 360 mg once daily and oral placebo once daily for 8 weeks. 12 subjects. | Drug: Mablet 360 mg<br> <br> * Other names: Magnesium hydroxide;Drug: Placebo<br> <br> |
| Experimental: Mablet 360 mg twice daily<br>Oral Mablet 360 mg twice daily for 8 weeks. 12 subjects. | Drug: Mablet 360 mg<br> <br> * Other names: Magnesium hydroxide;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intracellular magnesium | Intracellular magnesium measured by energy dispersive x-ray analysis (www.exatest.com). | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total serum magnesium |  | 8 weeks | 
| Ionized serum magnesium |  | 8 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Chronic Kidney Disease, Hypomagnesemia