Effect of Oral Magnesium on Vascular Calcification in Chronic Kidney Disease (NCT02542319) | Clinical Trial Compass
CompletedPhase 2
Effect of Oral Magnesium on Vascular Calcification in Chronic Kidney Disease
Denmark, Norway148 participantsStarted 2015-11
Plain-language summary
Randomized placebo-controlled double-blinded interventional trial to investigate the effect of oral magnesium supplementation on vascular calcification in subjects with chronic kidney disease. We hypothesize that oral magnesium supplementation will reduce vascular calcification in subjects with chronic kidney disease while not decreasing bone mineral density.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Estimated glomerular filtration rate between 45 and 15 mL/min for \> 3 months (i.e. CKD stage 3b-4).
* Serum total magnesium \< 0,82 mmol/L and serum phosphate \> 1,15 mmol/L on average of previous measurements.
or Serum total magnesium \< 0,92 mmol/L and serum phosphate \> 1,30 mmol/L on average of previous measurements.
* Life expectancy \> 1 year.
* Expected time until initiation of dialysis or transplantation \> 1 year.
* Women of childbearing age must be actively using contraceptive therapy (p-pills, estrogen depots or intrauterine device) as well as have a negative pregnancy test.
* Written informed consent.
Exclusion Criteria:
* Current hemodialysis or peritoneal dialysis treatment.
* Kidney donor recipient.
* Previous coronary artery bypass graft (CABG).
* Parathyroid hormone \> 600 ρmol/L.
* Previous parathyroidectomy.
* Current treatment with magnesium containing medication or supplements.
* Any condition impairing magnesium absorption from the gastrointestinal tract (e.g. short bowel syndrome, chronic pancreatitis).
* Active malignancy (basal or squamous cell skin carcinoma, localized prostate cancer and cancer with no signs of reoccurrence after 5 years are exempt from this).
* Other diseases or conditions, which, in the opinion of the site investigator, would prevent participation in or completion of trial.
* Pregnancy or breastfeeding.
* Allergy towards contents of interventional medication.
* Participation in other interventional tria…