The effect of magnesium supplementation on vascular calcification in chronic kidney disease-a randomised clinical trial (MAGiCAL-CKD): essential study design and rationale

TY - JOUR

T1 - The effect of magnesium supplementation on vascular calcification in chronic kidney disease-a randomised clinical trial (MAGiCAL-CKD)

T2 - essential study design and rationale

AU - Bressendorff, Iain

AU - Hansen, Ditte

AU - Schou, Morten

AU - Kragelund, Charlotte

AU - Brandi, Lisbet

N1 - © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

PY - 2017/6/1

Y1 - 2017/6/1

N2 - 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.

AB - 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.

KW - Adolescent

KW - Adult

KW - Aged

KW - Bone Density

KW - Coronary Artery Disease/diagnostic imaging

KW - Denmark

KW - Disease Progression

KW - Double-Blind Method

KW - Female

KW - Glomerular Filtration Rate

KW - Humans

KW - Kidney Failure, Chronic/complications

KW - Linear Models

KW - Logistic Models

KW - Magnesium/administration & dosage

KW - Male

KW - Middle Aged

KW - Norway

KW - Pulse Wave Analysis

KW - Renal Insufficiency, Chronic/complications

KW - Research Design

KW - Tomography, X-Ray Computed

KW - Vascular Calcification/diagnostic imaging

KW - Young Adult

U2 - 10.1136/bmjopen-2017-016795

DO - 10.1136/bmjopen-2017-016795

M3 - Journal article

C2 - 28645983

SN - 2044-6055

VL - 7

JO - B M J Open

JF - B M J Open

IS - 6

M1 - e016795

ER -