Magnesium Supplementation for Hypomagnesemia in Chronic Kidney Disease

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-08-31

Study Completion Date

2015-04-30

Brief Summary

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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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Detailed Description

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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.

Conditions

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Chronic Kidney Disease Hypomagnesemia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Placebo

Oral placebo twice daily for 8 weeks. 12 subjects.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Mablet 360 mg once daily

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

Group Type EXPERIMENTAL

Mablet 360 mg

Intervention Type DRUG

Placebo

Intervention Type DRUG

Mablet 360 mg twice daily

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

Group Type EXPERIMENTAL

Mablet 360 mg

Intervention Type DRUG

Interventions

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Mablet 360 mg

Intervention Type DRUG

Placebo

Intervention Type DRUG

Other Intervention Names

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Magnesium hydroxide

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No