Reversal Of Arterial Disease by modulating Magnesium and Phosphate (ROADMAP-study): rationale and design of a randomized controlled trial assessing the effects of magnesium citrate supplementation and phosphate-binding therapy on arterial stiffness in moderate chronic kidney disease.
Study Goal
The researchers aimed to determine whether 24 weeks of oral magnesium supplementation, with or without phosphate-binding therapy, could improve arterial stiffness and calcification propensity in stage 3-4 CKD patients.
Results Summary
The abstract does not provide results; it outlines the study design and rationale for investigating magnesium's potential effects on vascular calcification and arterial stiffness in CKD patients.
Population
Patients with stage 3-4 chronic kidney disease (estimated glomerular filtration rate of 15 to 50 ml/min/1.73 m²).
Effective Dosage
Not specified in the abstract.
Duration
24 weeks.
Interactions
None mentioned.
| Intervention | Direction | Endpoint | Population | Dosage | Impact | Claim # |
|---|---|---|---|---|---|---|
oral magnesium supplementation | decrease | arterial stiffness and calcification propensity | patients with stage 3-4 CKD | - | can improve | #1 |
oral magnesium supplementation with additional phosphate-binding therapy | decrease | arterial stiffness and calcification propensity | patients with stage 3-4 CKD | - | can improve | #2 |
magnesium citrate supplementation | decrease | the complex and deregulated mineral metabolism leading to vascular calcification and arterial stiffness | stage 3-4 CKD patients without overt hyperphosphatemia | - | aims to modulate | #3 |
phosphate-lowering therapy with sucroferric oxyhydroxide | decrease | the complex and deregulated mineral metabolism leading to vascular calcification and arterial stiffness | stage 3-4 CKD patients without overt hyperphosphatemia | - | aims to modulate | #4 |
BACKGROUND: Arterial stiffness and calcification propensity are associated with high cardiovascular risk and increased mortality in chronic kidney disease (CKD). Both magnesium and phosphate are recognized as modulators of vascular calcification and chronic inflammation, both features of CKD that contribute to arterial stiffness. In this paper, we outline the rationale and design of a randomized controlled trial (RCT) investigating whether 24 weeks of oral magnesium supplementation with or without additional phosphate-binding therapy can improve arterial stiffness and calcification propensity in patients with stage 3-4 CKD. METHODS: In this multi-center, placebo-controlled RCT, a total of 180 participants with an estimated glomerular filtration rate of 15 to 50 ml/min/1.73 m DISCUSSION: The combined intervention of magnesium citrate supplementation and phosphate-lowering therapy with sucroferric oxyhydroxide, in stage 3-4 CKD patients without overt hyperphosphatemia, aims to modulate the complex and deregulated mineral metabolism leading to vascular calcification and arterial stiffness and to establish to what extent this is mediated by T TRIAL REGISTRATION: Netherlands Trial Register, NL8252 (registered December 2019), EU clinical Trial Register 2019-001306-23 (registered November 2019).