The effect of magnesium supplementation on vascular calcification in chronic kidney disease—a randomised clinical trial (MAGiCAL-CKD): essential study design and rationale
What this study found
This paper presents the trial design and rationale rather than efficacy results. The primary endpoint is the difference in change in coronary artery calcification score from week 0 to week 52 between magnesium and placebo, measured by CT using the Agatston method. Secondary endpoints include cf-PWV, PWA, BMD, mineral metabolism markers, eGFR decline, major adverse cardiovascular events, all-cause and cardiovascular mortality, adverse events, and ESRD. The authors conclude that the study will test whether increasing magnesium uptake can slow vascular calcification progression in predialysis…
- Study & population
- Randomized, placebo-controlled clinical trial in 250 adults with predialysis chronic kidney disease stage 3b-4.
- Intervention
- Oral slow-release magnesium hydroxide (Mablet 360 mg) was tested at a daily dose of 30 mmol elemental magnesium, given as 2 tablets per day for 52 weeks, compared with placebo.
- Key limitation
- No clinical efficacy results are reported in this design paper.
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Open PDFOriginal abstract
Introduction Chronic kidney disease (CKD) is associated with an increased risk of cardiovascular disease and mortality, which is thought to be caused by increased propensity towards vascular calcification (VC). Magnesium (Mg) inhibits phosphate-induced VC in vitro and in animal models and serum Mg is inversely associated with cardiovascular mortality in predialysis CKD and in end-stage renal disease. This paper will describe the design and rationale of a randomised double-blinded placebo-controlled multicentre clinical trial, which will investigate whether oral Mg supplementation can prevent the progression of coronary artery calcification (CAC) in subjects with predialysis CKD. Methods and analysis We will randomise 250 subjects with estimated glomerular filtration rate of 15 to 45 mL/min/1.73 m2 to 12 months treatment with either slow-release Mg hydroxide 30 mmol/day or matching placebo in a 1:1 ratio. The primary end point is change in CAC score as measured by CT at baseline and after 12 months treatment. Secondary end points include change in pulse wave velocity, bone mineral density, measures of mineral metabolism and clinical end points related to cardiovascular and renal events. Ethics and dissemination This trial has been approved by the local biomedical research ethics committees and data protection agencies and will be performed in accordance with the latest revision of the Helsinki Declaration. The trial will examine for the first time the effect of increasing the uptake of a putative VC inhibitor (ie, Mg) on progression of CAC in subjects with predialysis CKD. Trial registration number NCT02542319, pre-results.