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The effect of magnesium supplementation on vascular calcification in chronic kidney disease-a randomised clinical trial (MAGiCAL-CKD): essential study design and rationale.
BMJ Open. 2017 06 23; 7(6):e016795.BO

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.

Authors+Show Affiliations

Department of Cardiology, Nephrology, and Endocrinology, Nordsjællands Hospital, Hillerød, Denmark.Department of Nephrology, Herlev and Gentofte Hospital, Herlev, Denmark.Department of Cardiology, Herlev and Gentofte Hospital, Herlev, Denmark.Department of Cardiology, Herlev and Gentofte Hospital, Herlev, Denmark.Department of Cardiology, Nephrology, and Endocrinology, Nordsjællands Hospital, Hillerød, Denmark.

Pub Type(s)

Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

28645983

Citation

Bressendorff, Iain, et al. "The Effect of Magnesium Supplementation On Vascular Calcification in Chronic Kidney Disease-a Randomised Clinical Trial (MAGiCAL-CKD): Essential Study Design and Rationale." BMJ Open, vol. 7, no. 6, 2017, pp. e016795.
Bressendorff I, Hansen D, Schou M, et al. The effect of magnesium supplementation on vascular calcification in chronic kidney disease-a randomised clinical trial (MAGiCAL-CKD): essential study design and rationale. BMJ Open. 2017;7(6):e016795.
Bressendorff, I., Hansen, D., Schou, M., Kragelund, C., & Brandi, L. (2017). The effect of magnesium supplementation on vascular calcification in chronic kidney disease-a randomised clinical trial (MAGiCAL-CKD): essential study design and rationale. BMJ Open, 7(6), e016795. https://doi.org/10.1136/bmjopen-2017-016795
Bressendorff I, et al. The Effect of Magnesium Supplementation On Vascular Calcification in Chronic Kidney Disease-a Randomised Clinical Trial (MAGiCAL-CKD): Essential Study Design and Rationale. BMJ Open. 2017 06 23;7(6):e016795. PubMed PMID: 28645983.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - The effect of magnesium supplementation on vascular calcification in chronic kidney disease-a randomised clinical trial (MAGiCAL-CKD): essential study design and rationale. AU - Bressendorff,Iain, AU - Hansen,Ditte, AU - Schou,Morten, AU - Kragelund,Charlotte, AU - Brandi,Lisbet, Y1 - 2017/06/23/ PY - 2017/6/25/entrez PY - 2017/6/25/pubmed PY - 2018/4/12/medline KW - Magnesium KW - chronic kidney disease KW - mineral metabolism KW - randomised clinical trial KW - vascular calcification SP - e016795 EP - e016795 JF - BMJ open JO - BMJ Open VL - 7 IS - 6 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. SN - 2044-6055 UR - https://www.unboundmedicine.com/medline/citation/28645983/The_effect_of_magnesium_supplementation_on_vascular_calcification_in_chronic_kidney_disease_a_randomised_clinical_trial__MAGiCAL_CKD_:_essential_study_design_and_rationale_ L2 - https://bmjopen.bmj.com/lookup/pmidlookup?view=long&pmid=28645983 DB - PRIME DP - Unbound Medicine ER -