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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Oral placebo twice daily for 8 weeks. 12 subjects. |
|
| Mablet 360 mg once daily | Experimental | Oral Mablet 360 mg once daily and oral placebo once daily for 8 weeks. 12 subjects. |
|
| Mablet 360 mg twice daily | Experimental | Oral Mablet 360 mg twice daily for 8 weeks. 12 subjects. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mablet 360 mg | Drug |
|
| |
| Measure | Description | Time Frame |
|---|---|---|
| Intracellular magnesium | Intracellular magnesium measured by energy dispersive x-ray analysis (www.exatest.com). | 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Total serum magnesium | 8 weeks | |
| Ionized serum magnesium | 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Markers of CKD-MBD (Chronic Kidney Disease - Mineral and Bone Disorder) | 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. | 8 weeks |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Iain B Bressendorff, MD | Department of Medicine, Division of Nephrology, Roskilde County Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Medicine, Division of Nephrology, Roskilde County Hospital | Roskilde | Denmark |
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| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
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| ID | Term |
|---|---|
| D008276 | Magnesium Hydroxide |
| ID | Term |
|---|---|
| D006878 | Hydroxides |
| D000468 | Alkalies |
| D007287 | Inorganic Chemicals |
| D000838 | Anions |
| D007477 |
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| Placebo |
| Drug |
|
| D005261 |
| Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| Ions |
| D004573 | Electrolytes |
| D017616 | Magnesium Compounds |