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The purpose of this trial is to examine the effect of increasing dialyse magnesium on serum calcification propensity in subjects with end-stage renal disease treated with haemodialysis.
Patients with end-stage renal disease (ESRD) have a 20-fold increased risk of cardiovascular mortality compared to the general population. Arterial stiffness, likely due to vascular calcification (VC), has been shown to predict cardiovascular mortality in ESRD. Serum calcification propensity (T50) is a novel biomarker, which is believed to reflect the propensity toward ectopic calcification (e.g. VC). Increasing serum magnesium (sMg) should increase T50, which might in turn reduce the formation of VC in patients with ESRD. A cheap and easy way of achieving this would be to increase the concentration of Mg in the dialysate (dMg) of patients with ESRD treated with haemodialysis (HD).
The investigators wish to conduct a randomised controlled double-blind clinical trial to examine whether increasing dMg will improve T50 in subjects with ESRD treated with HD.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dialysate magnesium 1.0 mmol/L | Experimental | Increase dialysate magnesium from 0.5 mmol/L to 1.0 mmol/L. |
|
| Dialysate magnesium 0.5 mmol/L | Active Comparator | Maintain dialysate magnesium at 0.5 mmol/L. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dialysate magnesium (1.0 mmol/L) | Other | Dialysate magnesium will be increased from 0.5 mmol/L to 1.0 mmol/L for 4 weeks after which subjects will return to dialysate magnesium 0.5 mmol/L for 2 weeks observation. |
| Measure | Description | Time Frame |
|---|---|---|
| Between-group difference in serum calcification propensity at follow-up | 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Within-group change in serum calcification propensity | 2 weeks | |
| Within-group change and between-group difference in serum magnesium | 4 weeks | |
| Change in serum magnesium after intervention |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Iain Bressendorff | Hillerød | 3400 | Denmark |
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| ID | Term |
|---|---|
| D012080 | Chronic Kidney Disease-Mineral and Bone Disorder |
| ID | Term |
|---|---|
| D012279 | Rickets |
| D001851 | Bone Diseases, Metabolic |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
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| Dialysate magnesium (0.5 mmol/L) | Other | Dialysate magnesium will be maintained at 0.5 mmol/L for the duration of the trial. |
|
| 2 weeks |
| Within-group change and between-group difference in serum parathyroid hormone | 4 weeks |
| Change in serum parathyroid hormone after intervention | 2 weeks |
| Change in fibroblast growth factor 23 during intervention | 4 weeks |
| Incidence of intradialytic hypotension during intervention | 4 weeks |
| D007674 |
| Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D002128 | Calcium Metabolism Disorders |
| D014808 | Vitamin D Deficiency |
| D001361 | Avitaminosis |
| D003677 | Deficiency Diseases |
| D044342 | Malnutrition |
| D009748 | Nutrition Disorders |
| D006962 | Hyperparathyroidism, Secondary |
| D006961 | Hyperparathyroidism |
| D010279 | Parathyroid Diseases |
| D004700 | Endocrine System Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |