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

Primary Purpose

Chronic Kidney Disease, Vascular Calcification, Uremic Osteodystrophy

Status

Completed

Phase

Phase 2

Locations

International

Study Type

Interventional

Intervention

Mablet 360 mg

Placebo

About this trial

This is an interventional treatment trial for Chronic Kidney Disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

Herlev Hospital
Nordsjællands Hospital
Akershus Universitetssykehus

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Magnesium

Placebo

Arm Description

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

Matching placebo tablets twice daily for 12 months.

Outcomes

Primary Outcome Measures

Coronary Artery Calcification (CAC) score

Agatston score assessed by CT scan.

Secondary Outcome Measures

Bone Mineral Density (BMD)

BMD assessed by quantitative CT.

Pulse Wave Velocity

Serum Calcification Propensity

Serum calcification propensity assessed by T50 analysis.

Full Information

NCT ID

NCT02542319

First Posted

September 3, 2015

Last Updated

September 1, 2022

Sponsor

Nordsjaellands Hospital

Collaborators

Herlev Hospital

1. Study Identification

Unique Protocol Identification Number

NCT02542319

Brief Title

Effect of Oral Magnesium on Vascular Calcification in Chronic Kidney Disease

Acronym

MagiCal-CKD

Official Title

The Effect of Oral Magnesium Supplementation on Vascular Calcification in Chronic Kidney Disease - A Randomized Clinical Trial

Study Type

Interventional

2. Study Status

Record Verification Date

June 2018

Overall Recruitment Status

Completed

Study Start Date

November 2015 (undefined)

Primary Completion Date

November 2020 (Actual)

Study Completion Date

July 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Nordsjaellands Hospital

Collaborators

Herlev Hospital

4. Oversight

Data Monitoring Committee

Yes

5. 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Chronic Kidney Disease, Vascular Calcification, Uremic Osteodystrophy

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Model Description

Randomized, double-blind, placebo-controlled, parallel-group

Masking

ParticipantInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

148 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Magnesium

Arm Type

Experimental

Arm Description

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

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Matching placebo tablets twice daily for 12 months.

Intervention Type

Dietary Supplement

Intervention Name(s)

Mablet 360 mg

Intervention Type

Dietary Supplement

Intervention Name(s)

Placebo

Primary Outcome Measure Information:

Title

Coronary Artery Calcification (CAC) score

Description

Agatston score assessed by CT scan.

Time Frame

12 months

Secondary Outcome Measure Information:

Title

Bone Mineral Density (BMD)

Description

BMD assessed by quantitative CT.

Time Frame

12 months

Title

Pulse Wave Velocity

Time Frame

12 months.

Title

Serum Calcification Propensity

Description

Serum calcification propensity assessed by T50 analysis.

Time Frame

12 months.

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Iain O Bressendorff, MD, PhD

Organizational Affiliation

Nordsjaellands Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Herlev Hospital

City

Herlev

ZIP/Postal Code

2730

Country

Denmark

Facility Name

Nordsjællands Hospital

City

Hillerød

ZIP/Postal Code

3400

Country

Denmark

Facility Name

Akershus Universitetssykehus

City

Lørenskog

ZIP/Postal Code

1478

Country

Norway

12. IPD Sharing Statement

Citations:

PubMed Identifier

28645983

Citation

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.

Results Reference

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Effect of Oral Magnesium on Vascular Calcification in Chronic Kidney Disease

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