Magnesium Supplementation for Hypomagnesemia in Chronic Kidney Disease

Chronic Kidney Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02216877
• Other study ID #: MgCKDRos
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: August 12, 2014
• Last updated: April 27, 2015
• Start date: August 2014
• Est. completion date: April 2015

Study information

• Verified date: April 2015
• Source: Roskilde County Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Danish Health and Medicines Authority
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: April 2015
• Est. primary completion date: April 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Kidney Disease
• Hypomagnesemia
• Kidney Diseases
• Renal Insufficiency, Chronic

Intervention

Drug:
• Mablet 360 mg

• Placebo

Locations

Country	Name	City	State
Denmark	Department of Medicine, Division of Nephrology, Roskilde County Hospital	Roskilde

Sponsors (1)

Lead Sponsor	Collaborator
Roskilde County Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Markers of CKD-MBD (Chronic Kidney Disease - Mineral and Bone Disorder)	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	No
Primary	Intracellular magnesium	Intracellular magnesium measured by energy dispersive x-ray analysis (www.exatest.com).	8 weeks	No
Secondary	Total serum magnesium		8 weeks	Yes
Secondary	Ionized serum magnesium		8 weeks	Yes