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

Sponsor

Nordsjaellands Hospital (Other)

Overall Status

Unknown status

CT.gov ID

NCT02542319

Collaborator

Herlev Hospital (Other)

250

Enrollment

Locations

Arms

Duration (Months)

83.3

Patients Per Site

1.5

Patients Per Site Per Month

Study Details

Study Description

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

Study Type:

Interventional

Anticipated 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 :

Nov 1, 2015

Anticipated Primary Completion Date :

Feb 1, 2020

Anticipated Study Completion Date :

May 1, 2020

Arms and Interventions

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

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

Primary Outcome Measures

Coronary Artery Calcification (CAC) score [12 months]
Agatston score assessed by CT scan.

Secondary Outcome Measures

Bone Mineral Density (BMD) [12 months]
BMD assessed by quantitative CT.
Pulse Wave Velocity [12 months.]
Serum Calcification Propensity [12 months.]
Serum calcification propensity assessed by T50 analysis.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	Country	Postal Code
1	Herlev Hospital	Herlev	Denmark	2730
2	Nordsjællands Hospital	Hillerød	Denmark	3400
3	Akershus Universitetssykehus	Lørenskog	Norway	1478

Sponsors and Collaborators

Nordsjaellands Hospital
Herlev Hospital

Investigators

Principal Investigator: Iain B Bressendorff, MD, Nordsjaellands Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Nordsjaellands Hospital

ClinicalTrials.gov Identifier:

NCT02542319

Other Study ID Numbers:

MagiCal-CKD

First Posted:

Sep 7, 2015

Last Update Posted:

Jun 6, 2018

Last Verified:

Jun 1, 2018

Additional relevant MeSH terms:

Kidney Diseases

Renal Insufficiency, Chronic

Calcinosis

Vascular Calcification

Study Results

No Results Posted as of Jun 6, 2018