Trials / Completed
CompletedNCT02542319
Effect of Oral Magnesium on Vascular Calcification in Chronic Kidney Disease
The Effect of Oral Magnesium Supplementation on Vascular Calcification in Chronic Kidney Disease - A Randomized Clinical Trial
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 148 (actual)
- Sponsor
- Nordsjaellands Hospital · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Detailed description
Chronic kidney disease (CKD) is associated with increase cardiovascular morbidity and mortality independent of traditional cardiovascular risk factors due to increased vascular calcification. Epidemiological and experimental data suggest that hypermagnesemia and magnesium supplementation reduce vascular calcification in CKD by increasing calcium/phosphate solubility in serum, by inhibiting calcium influx into vascular smooth muscle cells (VSMC), by inhibiting intracellular pro-calcification enzymes in VSMC and by increasing activity of intracellular anti-calcification enzymes in VSMC. However, there have been concerns that any anti-calcification effect of magnesium might also reduce bone mineral density, in which case there might be an increased risk of bone fractures associated with magnesium supplementation in CKD. We wish to conduct a randomized placebo-controlled double-blinded interventional trial to examine whether oral magnesium supplementation will reduce vascular calcification in subjects with CKD while not decreasing bone mineral density.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DIETARY_SUPPLEMENT | Mablet 360 mg | |
| DIETARY_SUPPLEMENT | Placebo |
Timeline
- Start date
- 2015-11-01
- Primary completion
- 2020-11-01
- Completion
- 2021-07-01
- First posted
- 2015-09-07
- Last updated
- 2022-09-06
Locations
3 sites across 2 countries: Denmark, Norway
Source: ClinicalTrials.gov record NCT02542319. Inclusion in this directory is not an endorsement.