NCT02216877

Brief Summary

Randomized placebo-controlled interventional trial to investigate the effect of oral magnesium supplementation on intracellular magnesium in subjects with chronic kidney disease. We hypothesize that oral magnesium supplementation will increase intracellular magnesium in subjects with chronic kidney disease as well as increase serum magnesium.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Aug 2014

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2014

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

August 12, 2014

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 15, 2014

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2015

Completed
Last Updated

April 28, 2015

Status Verified

April 1, 2015

Enrollment Period

8 months

First QC Date

August 12, 2014

Last Update Submit

April 27, 2015

Conditions

Chronic Kidney DiseaseHypomagnesemia

Keywords

Chronic Kidney DiseaseHypomagnesemia

Outcome Measures

Primary Outcomes (1)

  • Intracellular magnesium

    Intracellular magnesium measured by energy dispersive x-ray analysis (www.exatest.com).

    8 weeks

Secondary Outcomes (2)

  • Total serum magnesium

    8 weeks

  • Ionized serum magnesium

    8 weeks

Other Outcomes (1)

  • Markers of CKD-MBD (Chronic Kidney Disease - Mineral and Bone Disorder)

    8 weeks

Study Arms (3)

Placebo

PLACEBO COMPARATOR

Oral placebo twice daily for 8 weeks. 12 subjects.

Drug: Placebo

Mablet 360 mg once daily

EXPERIMENTAL

Oral Mablet 360 mg once daily and oral placebo once daily for 8 weeks. 12 subjects.

Drug: Mablet 360 mgDrug: Placebo

Mablet 360 mg twice daily

EXPERIMENTAL

Oral Mablet 360 mg twice daily for 8 weeks. 12 subjects.

Drug: Mablet 360 mg

Interventions

Mablet 360 mgDRUG
Also known as: Magnesium hydroxide
Mablet 360 mg once dailyMablet 360 mg twice daily
PlaceboDRUG
Mablet 360 mg once dailyPlacebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Estimated Glomerular filtration rate (eGFR) \< 60 mL/min.
  • Serum magnesium \< 0.82 mmol/L.
  • Written informed consent.

You may not qualify if:

  • Hemodialysis.
  • Peritoneal dialysis.
  • Kidney transplant recipient.
  • Parathyroid hormone \> 600 pg/L.
  • Pregnancy.
  • Comorbidity that makes study participation and completion impossible.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Medicine, Division of Nephrology, Roskilde County Hospital

Roskilde, Denmark

Location

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Interventions

Magnesium Hydroxide

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

HydroxidesAlkaliesInorganic ChemicalsAnionsIonsElectrolytesMagnesium Compounds

Study Officials

  • Iain B Bressendorff, MD

    Department of Medicine, Division of Nephrology, Roskilde County Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Medical Doctor

Study Record Dates

First Submitted

August 12, 2014

First Posted

August 15, 2014

Study Start

August 1, 2014

Primary Completion

April 1, 2015

Study Completion

April 1, 2015

Last Updated

April 28, 2015

Record last verified: 2015-04

Locations

DK(1)