Financiado en parte por AstraZeneca, Gedeon Richter, Novo Nordisk, Vifor Pharma
The Effect of Magnesium Supplementation on Vascular Calcification in CKD: A Randomized Clinical Trial (MAGiCAL-CKD)
Bressendorff I, Hansen D, Schou M, Kragelund C, Svensson M, Hashemi B, Kristensen T, Vrist MH, Borg R, Tougaard B, Borg K, Hjortkjær HØ, Kristiansen CH, Carlson N, Nasiri M, Ashraf H, Pasch A, Brandi L
Journal of the American Society of Nephrology : JASN · 39 citas
Etiquetas de revisión
Financiado por la industriaDatos neutrales que nuestra revisión registró sobre cómo se hizo este estudio. Describen el método, nunca si nos gusta el resultado.
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
- AstraZeneca
- Empresa
- Gedeon Richter
- Empresa
- Novo Nordisk
- Organización sin fines de lucro
- Dansk Nefrologisk Selskab
- Empresa
- Vifor Pharma
Según 5 financiadores declarados.
Publicación
- Publicado
- 2023-02-02 · J Am Soc Nephrol · vol. 34 · número 5 · págs. 886–894
- Editorial
- American Society of Nephrology
- Citado
- 54 citas · más que el 98% de estudios similares · 6.5× el promedio de su campo
- Impacto
- Entre el 10 % más citado de su campo
- Referencias
- 18 trabajos
- Acceso
- Acceso abierto (revista) · OTHER-OA
- Áreas de investigación
- Magnesium in Health and Disease · Parathyroid Disorders and Treatments · Potassium and Related Disorders
- Palabras clave
- Medicine, Randomized controlled trial, Magnesium, Internal medicine, Kidney disease, Calcification, Chemistry
- MeSH
- humans, magnesium, dietary supplements, renal insufficiency, chronic, coronary artery disease, vascular calcification
18 autores
- Iain Oshoj Bressendorff🇩🇰 · autor de correspondenciaGentofte Hospital; Nordsjællands Hospital
- Ditte Hansen🇩🇰Aalborg University Hospital; Odense University Hospital; Aarhus University Hospital; Gentofte Hospital; Rigshospitalet; Zealand University Hospital
- Morten Schou🇩🇰Aalborg University Hospital; Odense University Hospital; Aarhus University Hospital; Gentofte Hospital; Rigshospitalet; Zealand University Hospital
- Charlotte Kragelund🇩🇰Aalborg University Hospital; Odense University Hospital; Aarhus University Hospital; Gentofte Hospital; Rigshospitalet; Zealand University Hospital; Nordsjællands Hospital
- My Hanna Sofia Svensson🇳🇴Akershus University Hospital
- Bahram Hashemi🇩🇰Aalborg University Hospital; Odense University Hospital; Aarhus University Hospital; Gentofte Hospital; Rigshospitalet; Zealand University Hospital
- Tilde Kristensen🇩🇰Aalborg University Hospital; Odense University Hospital; Aarhus University Hospital; Gentofte Hospital; Rigshospitalet; Zealand University Hospital; Regional Hospital Central Jutland
- Marie Houmaa Vrist🇩🇰Aalborg University Hospital; Odense University Hospital; Aarhus University Hospital; Gentofte Hospital; Rigshospitalet; Zealand University Hospital
- Rikke Borg🇩🇰 · autor de correspondenciaAalborg University Hospital; Odense University Hospital; Aarhus University Hospital; Gentofte Hospital; Rigshospitalet; Zealand University Hospital
- Birgitte Godskesen Tougaard🇩🇰Aalborg University Hospital; Odense University Hospital; Aarhus University Hospital; Gentofte Hospital; Rigshospitalet; Zealand University Hospital
- Kristine Borg🇩🇰 · autor de correspondenciaAalborg University Hospital; Odense University Hospital; Aarhus University Hospital; Gentofte Hospital; Rigshospitalet; Zealand University Hospital
- Henrik Øder Hjortkjær🇩🇰Aalborg University Hospital; Odense University Hospital; Aarhus University Hospital; Gentofte Hospital; Rigshospitalet; Zealand University Hospital
- Cathrine Helgestad Kristiansen🇩🇰🇳🇴Aalborg University Hospital; Akershus University Hospital; Odense University Hospital; Aarhus University Hospital; Gentofte Hospital; Rigshospitalet; Zealand University Hospital
- Nicholas Carlson🇩🇰Aalborg University Hospital; Odense University Hospital; Aarhus University Hospital; Gentofte Hospital; Rigshospitalet; Zealand University Hospital
- Mohammad Nasiri🇩🇰Aalborg University Hospital; Odense University Hospital; Aarhus University Hospital; Gentofte Hospital; Rigshospitalet; Zealand University Hospital; Lillebaelt Hospital
- Haseem Ashraf🇩🇰🇳🇴Aalborg University Hospital; Akershus University Hospital; Odense University Hospital; Aarhus University Hospital; Gentofte Hospital; Rigshospitalet; Zealand University Hospital
- Andreas Pasch🇦🇹🇩🇰Johannes Kepler University of Linz; Aalborg University Hospital; Odense University Hospital; Aarhus University Hospital; Gentofte Hospital; Rigshospitalet; Zealand University Hospital
- Lisbet Brandi🇩🇰Nordsjællands Hospital
Resumen
El texto original del estudio, en el idioma en que se publicó.
Significance statement
Magnesium prevents vascular calcification in animals with CKD. In addition, lower serum magnesium is associated with higher risk of cardiovascular events in CKD. In a randomized, double-blinded, placebo-controlled trial, the authors investigated the effects of magnesium supplementation versus placebo on vascular calcification in patients with predialysis CKD. Despite significant increases in plasma magnesium among study participants who received magnesium compared with those who received placebo, magnesium supplementation did not slow the progression of vascular calcification in study participants. In addition, the findings showed a higher incidence of serious adverse events in the group treated with magnesium. Magnesium supplementation alone was not sufficient to delay progression of vascular calcification, and other therapeutic strategies might be necessary to reduce the risk of cardiovascular disease in CKD.
Background
Elevated levels of serum magnesium are associated with lower risk of cardiovascular events in patients with CKD. Magnesium also prevents vascular calcification in animal models of CKD.
Methods
To investigate whether oral magnesium supplementation would slow the progression of vascular calcification in CKD, we conducted a randomized, double-blinded, placebo-controlled, parallel-group, clinical trial. We enrolled 148 subjects with an eGFR between 15 and 45 ml/min and randomly assigned them to receive oral magnesium hydroxide 15 mmol twice daily or matching placebo for 12 months. The primary end point was the between-groups difference in coronary artery calcification (CAC) score after 12 months adjusted for baseline CAC score, age, and diabetes mellitus.
Results
A total of 75 subjects received magnesium and 73 received placebo. Median eGFR was 25 ml/min at baseline, and median baseline CAC scores were 413 and 274 in the magnesium and placebo groups, respectively. Despite plasma magnesium increasing significantly during the trial in the magnesium group, the baseline-adjusted CAC scores did not differ significantly between the two groups after 12 months. Prespecified subgroup analyses according to CAC>0 at baseline, diabetes mellitus, or tertiles of serum calcification propensity did not significantly alter the main results. Among subjects who experienced gastrointestinal adverse effects, 35 were in the group receiving magnesium treatment versus nine in the placebo group. Five deaths and six cardiovascular events occurred in the magnesium group compared with two deaths and no cardiovascular events in the placebo group.
Conclusions
Magnesium supplementation for 12 months did not slow the progression of vascular calcification in CKD, despite a significant increase in plasma magnesium.
Clinical trials registration
www.clinicaltrials.gov ( NCT02542319 ).
Resumen vía Europe PMC. Los derechos de autor siguen siendo de los autores o la editorial.
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