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Effect of Oral Magnesium on Vascular Calcification in Chronic Kidney Disease (MagiCal-CKD)

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ClinicalTrials.gov Identifier: NCT02542319
Recruitment Status : Unknown
Verified June 2018 by Nordsjaellands Hospital.
Recruitment status was:  Recruiting
First Posted : September 7, 2015
Last Update Posted : June 6, 2018
Sponsor:
Collaborator:
Herlev Hospital
Information provided by (Responsible Party):
Nordsjaellands Hospital

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Chronic Kidney Disease Vascular Calcification Uremic Osteodystrophy Dietary Supplement: Mablet 360 mg Dietary Supplement: Placebo Phase 2 Phase 3

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 250 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Effect of Oral Magnesium Supplementation on Vascular Calcification in Chronic Kidney Disease - A Randomized Clinical Trial
Study Start Date : November 2015
Estimated Primary Completion Date : February 2020
Estimated Study Completion Date : May 2020

Resource links provided by the National Library of Medicine

Drug Information available for: Magnesium

Arms and Interventions
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Arm Intervention/treatment
Experimental: Magnesium
Oral Magnesium Hydroxide (Mablet 360 mg) twice daily for 12 months.
 Dietary Supplement: Mablet 360 mg
Placebo Comparator: Placebo
Matching placebo tablets twice daily for 12 months.
 Dietary Supplement: Placebo


Outcome Measures
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Primary Outcome Measures :
  1. Coronary Artery Calcification (CAC) score [ Time Frame: 12 months ]
    Agatston score assessed by CT scan.


Secondary Outcome Measures :
  1. Bone Mineral Density (BMD) [ Time Frame: 12 months ]
    BMD assessed by quantitative CT.

  2. Pulse Wave Velocity [ Time Frame: 12 months. ]
  3. Serum Calcification Propensity [ Time Frame: 12 months. ]
    Serum calcification propensity assessed by T50 analysis.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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 trials.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02542319


Contacts
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Contact: Iain B Bressendorff, MD +4524277139 iain.bressendorff@regionh.dk
Contact: Lisbet Brandi, MD, DMSc +4520542458 lisbet.brandi@regionh.dk

Locations
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Denmark
Herlev Hospital Recruiting
Herlev, Denmark, 2730
Contact: Ditte Hansen, MD PhD    +4538682056    ditte.hansen.04@regionh.dk   
Nordsjællands Hospital Recruiting
Hillerød, Denmark, 3400
Contact: Iain B Bressendorff, MD    +4524277139    iain.bressendorff@regionh.dk   
Contact: Lisbet Brandi, MD DSMc    +4548295993    lisbet.brandi@regionh.dk   
Norway
Akershus Universitetssykehus Recruiting
Lørenskog, Norway, 1478
Contact: My Svensson, MD PhD    +4791569601    m.h.s.svensson@medisin.uio.no   
Sponsors and Collaborators
Nordsjaellands Hospital
Herlev Hospital
Investigators
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Principal Investigator: Iain B Bressendorff, MD North Zealand Hospital
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Nordsjaellands Hospital
ClinicalTrials.gov Identifier: NCT02542319    
Other Study ID Numbers: MagiCal-CKD
First Posted: September 7, 2015    Key Record Dates
Last Update Posted: June 6, 2018
Last Verified: June 2018
Additional relevant MeSH terms:
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Kidney Diseases
Renal Insufficiency, Chronic
Calcinosis
Vascular Calcification
 Urologic Diseases
Renal Insufficiency
Calcium Metabolism Disorders
Metabolic Diseases