Funded in part by Toyota Foundation
The effect of magnesium supplementation on vascular calcification in chronic kidney disease-a randomised clinical trial (MAGiCAL-CKD): essential study design and rationale
Bressendorff I, Hansen D, Schou M, Kragelund C, Brandi L
BMJ open · 26 citations
Review labels
Neutral facts our review recorded about how this study was done. They describe method, never whether we like the result.
How it was studied
- Design
- Randomized controlled trial (indexed by PubMed)
- Studied in
- People
- Main outcome
- Health markers and function
Who paid for it
- Funding
- Industry funded
- Company
- Toyota Foundation
- Nonprofit
- Dansk Nefrologisk Selskab
Based on 2 listed funder(s).
Publication
- Published
- 2017-06-01 · BMJ Open · vol. 7 · issue 6 · p. e016795
- Publisher
- BMJ
- Cited
- 36 citations · more than 93% of similar papers · 3.5× the field average
- Impact
- Top 10% most cited in its field
- References
- 45 works
- Access
- Open access (journal) · CC-BY-NC
- Research areas
- Magnesium in Health and Disease · Parathyroid Disorders and Treatments · Potassium and Related Disorders
- Keywords
- Medicine, Kidney disease, Alternative medicine, Clinical trial, Randomized controlled trial, Internal medicine, Intensive care medicine, Disease, Magnesium, Physical therapy, Pathology
- MeSH
- humans, kidney failure, chronic, disease progression, magnesium, tomography, x-ray computed, glomerular filtration rate, linear models, logistic models, double-blind method, bone density, research design, adolescent, adult, aged, middle aged, denmark, norway, female, male, renal insufficiency, chronic, coronary artery disease, young adult, vascular calcification, pulse wave analysis
5 authors
From DK
- Iain Oshoj Bressendorff · correspondingNordsjællands Hospital
- Ditte HansenGentofte Hospital
- Morten SchouGentofte Hospital
- Charlotte KragelundGentofte Hospital
- Lisbet BrandiNordsjællands Hospital
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.
Abstract via Europe PMC. Copyright remains with the authors or publisher (CC BY-NC).
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