Magnesium Supplementation for Hypomagnesemia in Chronic Kidney Disease

Zealand University Hospital

Status and phase: Completed; Phase 2; Phase 1

Conditions: Chronic Kidney Disease; Hypomagnesemia

Treatments: Drug: Placebo; Drug: Mablet 360 mg

Study type: Interventional

Funder types: Other

Identifiers

NCT02216877

MgCKDRos

Details and patient eligibility

About

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.

Full 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.

Enrollment: 36 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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36 participants in 3 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

Oral placebo twice daily for 8 weeks. 12 subjects.

Treatment:

Drug: Placebo

Mablet 360 mg once daily

Experimental group

Description:

Oral Mablet 360 mg once daily and oral placebo once daily for 8 weeks. 12 subjects.

Treatment:

Drug: Mablet 360 mg

Drug: Placebo

Mablet 360 mg twice daily

Experimental group

Description:

Oral Mablet 360 mg twice daily for 8 weeks. 12 subjects.

Treatment:

Drug: Mablet 360 mg