Effect of Oral Magnesium on Vascular Calcification in Chronic Kidney Disease

NCT02542319 | Completed Phase 2 DMC

• 1 other identifier: MagiCal-CKD
• Study Type: interventional
• Target: 148
• Locations: 2 countries
• Sites: 3

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.

Conditions

Chronic Kidney Disease; Vascular Calcification; Uremic Osteodystrophy

Outcome Measures

Primary Outcomes (1)

• Coronary Artery Calcification (CAC) score

  Agatston score assessed by CT scan.

  12 months

Secondary Outcomes (3)

• Bone Mineral Density (BMD)

  12 months

• Pulse Wave Velocity

  12 months.

• Serum Calcification Propensity

  12 months.

Study Arms (2)

Magnesium

EXPERIMENTAL

Oral Magnesium Hydroxide (Mablet 360 mg) twice daily for 12 months.

Dietary Supplement: Mablet 360 mg

Placebo

PLACEBO COMPARATOR

Matching placebo tablets twice daily for 12 months.

Dietary Supplement: Placebo

Interventions

Mablet 360 mg DIETARY_SUPPLEMENT

Magnesium

Placebo DIETARY_SUPPLEMENT

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Nordsjaellands Hospital: lead
• Herlev Hospital: collaborator

Study Sites (3)

Herlev Hospital

Herlev, 2730, Denmark

Location

Nordsjællands Hospital

Hillerød, 3400, Denmark

Location

Akershus Universitetssykehus

Lørenskog, 1478, Norway

Location

Related Publications (2)

• Bressendorff I, Hansen D, Schou M, Kragelund C, Svensson M, Hashemi B, Kristensen T, Vrist MH, Borg R, Tougaard B, Borg K, Hjortkjaer HO, Kristiansen CH, Carlson N, Nasiri M, Ashraf H, Pasch A, Brandi L. The Effect of Magnesium Supplementation on Vascular Calcification in CKD: A Randomized Clinical Trial (MAGiCAL-CKD). J Am Soc Nephrol. 2023 May 1;34(5):886-894. doi: 10.1681/ASN.0000000000000092. Epub 2023 Feb 2.

  PMID: 36749131 DERIVED

• Bressendorff I, Hansen D, Schou M, Kragelund C, Brandi L. The effect of magnesium supplementation on vascular calcification in chronic kidney disease-a randomised clinical trial (MAGiCAL-CKD): essential study design and rationale. BMJ Open. 2017 Jun 23;7(6):e016795. doi: 10.1136/bmjopen-2017-016795.

  PMID: 28645983 DERIVED

MeSH Terms

Conditions

Renal Insufficiency, Chronic; Vascular Calcification

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Calcinosis; Calcium Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Iain O Bressendorff, MD, PhD

  Nordsjaellands Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized, double-blind, placebo-controlled, parallel-group

Study Record Dates

• First Submitted: September 3, 2015
• First Posted: September 7, 2015
• Study Start: November 1, 2015
• Primary Completion: November 1, 2020
• Study Completion: July 1, 2021
• Last Updated: September 6, 2022

Record last verified: 2018-06

Locations

NO (1); DK (2)