Magnesium Supplementation for Hypomagnesemia in Chronic Kidney Disease

Overview

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 Title of Study: “Magnesium Supplementation for Hypomagnesemia in Chronic Kidney Disease – A Dose-Finding Trial”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Double (Participant, Investigator)
  • Study Primary Completion Date: April 2015

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

  • Drug: Mablet 360 mg
  • Drug: Placebo

Arms, Groups and Cohorts

  • Placebo Comparator: Placebo
    • Oral placebo twice daily for 8 weeks. 12 subjects.
  • Experimental: Mablet 360 mg once daily
    • Oral Mablet 360 mg once daily and oral placebo once daily for 8 weeks. 12 subjects.
  • Experimental: Mablet 360 mg twice daily
    • Oral Mablet 360 mg twice daily for 8 weeks. 12 subjects.

Clinical Trial Outcome Measures

Primary Measures

  • Intracellular magnesium
    • Time Frame: 8 weeks
    • Intracellular magnesium measured by energy dispersive x-ray analysis (www.exatest.com).

Secondary Measures

  • Total serum magnesium
    • Time Frame: 8 weeks
  • Ionized serum magnesium
    • Time Frame: 8 weeks

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Zealand University Hospital
  • Provider of Information About this Clinical Study
    • Principal Investigator: Iain Bressendorff, Medical Doctor – Zealand University Hospital
  • Overall Official(s)
    • Iain B Bressendorff, MD, Principal Investigator, Department of Medicine, Division of Nephrology, Roskilde County Hospital

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