Chronic Kidney Disease, Hypomagnesemia
Conditions
Keywords
Chronic Kidney Disease, Hypomagnesemia
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.
Interventions
DRUGMablet 360 mg
DRUGPlacebo
Sponsors
Zealand University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Intracellular magnesium | 8 weeks | Intracellular magnesium measured by energy dispersive x-ray analysis (www.exatest.com). |
Secondary
| Measure | Time frame |
|---|---|
| Total serum magnesium | 8 weeks |
| Ionized serum magnesium | 8 weeks |
Other
| Measure | Time frame | Description |
|---|---|---|
| Markers of CKD-MBD (Chronic Kidney Disease - Mineral and Bone Disorder) | 8 weeks | 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. |
Countries
Denmark
Outcome results
None listed