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NCT Number: NCT02216877

Magnesium Supplementation for Hypomagnesemia in Chronic Kidney Disease

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.

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Key information

Conditions

Chronic Kidney Disease Chronic Disease Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Hypomagnesemia Kidney Diseases Male Urogenital Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Department of Medicine, Division of Nephrology, Roskilde County Hospital

Roskilde, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Mablet 360 mg

Drug

Other names: Magnesium hydroxide

Placebo

Drug

Primary outcomes

  1. Intracellular magnesium

    Time frame: 8 weeks

    Intracellular magnesium measured by energy dispersive x-ray analysis (www.exatest.com).

Secondary outcomes

  1. Total serum magnesium

    Time frame: 8 weeks

  2. Ionized serum magnesium

    Time frame: 8 weeks

Other outcomes

  1. Markers of CKD-MBD (Chronic Kidney Disease - Mineral and Bone Disorder)

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Zealand University Hospital

Other

Registry information

Official study title

Magnesium Supplementation for Hypomagnesemia in Chronic Kidney Disease - A Dose-Finding Trial

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Aug 15, 2014
Registry last updated
Apr 28, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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