Effect of Oral Magnesium on Vascular Calcification in Chronic Kidney Disease

Chronic Kidney Disease Clinical Trial

— MagiCal-CKD  

Official title:

The Effect of Oral Magnesium Supplementation on Vascular Calcification in Chronic Kidney Disease - A Randomized Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02542319
• Other study ID #: MagiCal-CKD
• Status: Completed
• Phase: Phase 2
• Start date: November 2015
• Est. completion date: July 2021

Study information

• Verified date: June 2018
• Source: Nordsjaellands Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Randomized placebo-controlled double-blinded interventional trial to investigate the effect of oral magnesium supplementation on vascular calcification in subjects with chronic kidney disease. We hypothesize that oral magnesium supplementation will reduce vascular calcification in subjects with chronic kidney disease while not decreasing bone mineral density.

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 CKD 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. However, there have been concerns that any anti-calcification effect of magnesium might also reduce bone mineral density, in which case there might be an increased risk of bone fractures associated with magnesium supplementation in CKD. We wish to conduct a randomized placebo-controlled double-blinded interventional trial to examine whether oral magnesium supplementation will reduce vascular calcification in subjects with CKD while not decreasing bone mineral density.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 148
• Est. completion date: July 2021
• Est. primary completion date: November 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Estimated glomerular filtration rate between 45 and 15 mL/min for > 3 months (i.e. CKD stage 3b-4).

• Serum total magnesium < 0,82 mmol/L and serum phosphate > 1,15 mmol/L on average of previous measurements.

or Serum total magnesium < 0,92 mmol/L and serum phosphate > 1,30 mmol/L on average of previous measurements.

• Life expectancy > 1 year.

• Expected time until initiation of dialysis or transplantation > 1 year.

• Women of childbearing age must be actively using contraceptive therapy (p-pills, estrogen depots or intrauterine device) as well as have a negative pregnancy test.

• Written informed consent.

Exclusion Criteria:

• Current hemodialysis or peritoneal dialysis treatment.

• Kidney donor recipient.

• Previous coronary artery bypass graft (CABG).

• Parathyroid hormone > 600 ?mol/L.

• Previous parathyroidectomy.

• Current treatment with magnesium containing medication or supplements.

• Any condition impairing magnesium absorption from the gastrointestinal tract (e.g. short bowel syndrome, chronic pancreatitis).

• Active malignancy (basal or squamous cell skin carcinoma, localized prostate cancer and cancer with no signs of reoccurrence after 5 years are exempt from this).

• Other diseases or conditions, which, in the opinion of the site investigator, would prevent participation in or completion of trial.

• Pregnancy or breastfeeding.

• Allergy towards contents of interventional medication.

• Participation in other interventional trials.

Related Conditions & MeSH terms

• Calcinosis
• Chronic Kidney Disease
• Kidney Diseases
• Renal Insufficiency, Chronic
• Uremic Osteodystrophy
• Vascular Calcification

Intervention

Dietary Supplement:
• Mablet 360 mg

• Placebo

Locations

Country	Name	City	State
Denmark	Herlev Hospital	Herlev
Denmark	Nordsjællands Hospital	Hillerød
Norway	Akershus Universitetssykehus	Lørenskog

Sponsors (2)

Lead Sponsor	Collaborator
Nordsjaellands Hospital	Herlev Hospital

Countries where clinical trial is conducted

Denmark,  Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Coronary Artery Calcification (CAC) score	Agatston score assessed by CT scan.	12 months
Secondary	Bone Mineral Density (BMD)	BMD assessed by quantitative CT.	12 months
Secondary	Pulse Wave Velocity		12 months.
Secondary	Serum Calcification Propensity	Serum calcification propensity assessed by T50 analysis.	12 months.