Magnesium Supplementation for Hypomagnesemia in Chronic Kidney Disease

Phase 1

Completed

• Conditions: Hypomagnesemia; Chronic Kidney Disease
• Interventions: Drug: Mablet 360 mg; Drug: Placebo

• Registration Number: NCT02216877
• Lead Sponsor: Zealand University Hospital

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.

Study Timeline

• Study Start: 2014-08
• Study First Submitted: 2014-08-12
• Study First Submitted QC: 2014-08-12
• Study First Posted: 2014-08-15
• Status Verified: 2015-04
• Primary Completion: 2015-04
• Study Completion: 2015-04
• Last Update Submitted: 2015-04-27
• Last Update Posted: 2015-04-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 36

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Mablet 360 mg once daily	Mablet 360 mg	Oral Mablet 360 mg once daily and oral placebo once daily for 8 weeks. 12 subjects.
Mablet 360 mg once daily	Placebo	Oral Mablet 360 mg once daily and oral placebo once daily for 8 weeks. 12 subjects.
Placebo	Placebo	Oral placebo twice daily for 8 weeks. 12 subjects.
Mablet 360 mg twice daily	Mablet 360 mg	Oral Mablet 360 mg twice daily for 8 weeks. 12 subjects.

Primary Outcome Measures

Name	Time	Method
Intracellular magnesium	8 weeks	Intracellular magnesium measured by energy dispersive x-ray analysis (www.exatest.com).

Secondary Outcome Measures

Name	Time	Method
Ionized serum magnesium	8 weeks
Total serum magnesium	8 weeks

Trial Locations

Locations (1)

Department of Medicine, Division of Nephrology, Roskilde County Hospital; 🇩🇰 Roskilde, Denmark