Financiado en parte por 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 citas
Etiquetas de revisión
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Cómo se estudió
- Diseño
- Ensayo controlado aleatorizado (indexado por PubMed)
- Estudiado en
- Personas
- Resultado principal
- Marcadores de salud y funcionamiento
Quién lo pagó
- Financiación
- Financiado por la industria
- Empresa
- Toyota Foundation
- Organización sin fines de lucro
- Dansk Nefrologisk Selskab
Según 2 financiadores declarados.
Publicación
- Publicado
- 2017-06-01 · BMJ Open · vol. 7 · número 6 · pág. e016795
- Editorial
- BMJ
- Citado
- 36 citas · más que el 93% de estudios similares · 3.5× el promedio de su campo
- Impacto
- Entre el 10 % más citado de su campo
- Referencias
- 45 trabajos
- Acceso
- Acceso abierto (revista) · CC-BY-NC
- Áreas de investigación
- Magnesium in Health and Disease · Parathyroid Disorders and Treatments · Potassium and Related Disorders
- Palabras clave
- 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 autores
- Iain Oshoj Bressendorff🇩🇰 · autor de correspondenciaNordsjællands Hospital
- Ditte Hansen🇩🇰Gentofte Hospital
- Morten Schou🇩🇰Gentofte Hospital
- Charlotte Kragelund🇩🇰Gentofte Hospital
- Lisbet Brandi🇩🇰Nordsjællands Hospital
Resumen
El texto original del estudio, en el idioma en que se publicó.
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.
Resumen vía Europe PMC. Los derechos de autor siguen siendo de los autores o la editorial (CC BY-NC).
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