Chronic Kidney Disease Clinical Trial
Official title:
Magnesium Supplementation for Hypomagnesemia in Chronic Kidney Disease - A Dose-Finding Trial
Verified date | April 2015 |
Source | Roskilde County Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | Denmark: Danish Health and Medicines Authority |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 36 |
Est. completion date | April 2015 |
Est. primary completion date | April 2015 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Estimated Glomerular filtration rate (eGFR) < 60 mL/min. - Serum magnesium < 0.82 mmol/L. - Written informed consent. Exclusion Criteria: - Hemodialysis. - Peritoneal dialysis. - Kidney transplant recipient. - Parathyroid hormone > 600 pg/L. - Pregnancy. - Comorbidity that makes study participation and completion impossible. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Denmark | Department of Medicine, Division of Nephrology, Roskilde County Hospital | Roskilde |
Lead Sponsor | Collaborator |
---|---|
Roskilde County Hospital |
Denmark,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Markers of CKD-MBD (Chronic Kidney Disease - Mineral and Bone Disorder) | Serum calcium, phosphate, parathyroid hormone (PTH), fibroblast growth factor 23 (FGF-23), 25-(OH)-hydroxy vitamin D, 1,25-(OH)-dihydroxy vitamin D as well as urine calcium and phosphate. | 8 weeks | No |
Primary | Intracellular magnesium | Intracellular magnesium measured by energy dispersive x-ray analysis (www.exatest.com). | 8 weeks | No |
Secondary | Total serum magnesium | 8 weeks | Yes | |
Secondary | Ionized serum magnesium | 8 weeks | Yes |
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