Magnesium Supplementation for Hypomagnesemia in Chronic Kidney Disease

April 27, 2015 updated by: Iain Bressendorff, Zealand University Hospital

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

36

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Roskilde, Denmark
        • Department of Medicine, Division of Nephrology, Roskilde County Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Oral placebo twice daily for 8 weeks. 12 subjects.
Drug: Placebo
Experimental: Mablet 360 mg once daily
Oral Mablet 360 mg once daily and oral placebo once daily for 8 weeks. 12 subjects.
Drug: Placebo
Drug: Mablet 360 mg
Other Names:
  • Magnesium hydroxide
Experimental: Mablet 360 mg twice daily
Oral Mablet 360 mg twice daily for 8 weeks. 12 subjects.
Drug: Mablet 360 mg
Other Names:
  • Magnesium hydroxide

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
Total serum magnesium
Time Frame: 8 weeks
8 weeks
Ionized serum magnesium
Time Frame: 8 weeks
8 weeks

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Zealand University Hospital

Investigators

  • Principal Investigator: Iain B Bressendorff, MD, Department of Medicine, Division of Nephrology, Roskilde County Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2014

Primary Completion (Actual)

April 1, 2015

Study Completion (Actual)

April 1, 2015

Study Registration Dates

First Submitted

August 12, 2014

First Submitted That Met QC Criteria

August 12, 2014

First Posted (Estimate)

August 15, 2014

Study Record Updates

Last Update Posted (Estimate)

April 28, 2015

Last Update Submitted That Met QC Criteria

April 27, 2015

Last Verified

April 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MgCKDRos

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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