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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02216877
Other study ID # MgCKDRos
Secondary ID
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


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
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