Effect of Magnesium Supplementation on Patients With Diabetic Nephropathy

Not Applicable

• Conditions: Diabetes
• Interventions: Dietary Supplement: Magnesium Oxide

• Registration Number: NCT02220036
• Lead Sponsor: Isfahan University of Medical Sciences

Brief Summary

This is a double-blind randomized clinical trial which will start at June 2014 and end on June 2015 in Isfahan city. Serum creatinine level is considered as a key variable and the sample size calculated 80 persons (40 persons for control group and 40 persons for patient group). Patients aged more than 18 years old with diabetic nephropathy having Fasting Blood Sugar more than 126 mg/dL and proteinuria 30-300 mg/dL (microalbuminuria) and Glomerular Filtration Rate more than 90 mL/min will be chosen. Patient group will receive magnesium supplement (250 milligram) and the other group will receive placebo which is similar to the magnesium tablets in color, odor and appearance both for 12 weeks. All subjects will complete 4 physical activity and 4 dietary records. Outcome measurements including metabolic, renal and inflammatory profiles will be measured at the beginning and end of the study as well as anthropometric measurements.

Detailed Description

This is a double-blind randomized clinical trial which will start at June 2014 and end on June 2015 in Isfahan city. Serum creatinine level is considered as a key variable and the sample size calculated 80 persons (40 persons for control group and 40 persons for patient group).

Study Timeline

• Study Start: 2014-06
• Status Verified: 2014-08
• Primary Completion: 2014-08
• Study First Submitted: 2014-08-18
• Study First Submitted QC: 2014-08-18
• Last Update Submitted: 2014-08-18
• Study First Posted: 2014-08-19
• Last Update Posted: 2014-08-19
• Study Completion: 2014-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

• more than 18 years old
• diabetic nephropathy
• Fasting Blood Sugar more than 126 milligram per deciliter
• Proteinuria 30-300 milligram per deciliter (microalbuminuria)
• Glomerular Filtration Rate more than 90 milliliter per minute
• Not having hyperthyroidism or hypothyroidism
• Not having any feverish urinary tract infection
• Not using any kind of drug including Cigarette
• Not having any liver disease
• Not having any cancer and inflammatory diseases
• Not having more than 4 kilogram weight loss during last 3 months
• Not using any magnesium-rich supplement

Exclusion Criteria

• changing medicine dose
• Not having adherence (using less than 75 percent of medicines)
• Cardiac Arrhythmias

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Magnesium Oxide	Magnesium Oxide	magnesium tablets, 250 milligram magnesium, 12 weeks, every day 1 tablet

Primary Outcome Measures

Name	Time	Method
Serum creatinine	12 weeks

Secondary Outcome Measures

Name	Time	Method
Proteinuria	12 weeks
Serum insulin level	12 weeks
High Density Lipoprotein	12 weeks
Low Density Lipoprotein	12 weeks
Very Low Density Lipoprotein	12 weeks
Blood Urine Nitrogen	12 weeks
Glomerular Filtration Rate	12 weeks
Fasting Blood Sugar	12 weeks
Triglyceride	12 weeks
Total Cholesterol	12 weeks
high sensitive C-Reactive Protein	12 week
Hemoglobin A1c	12 weeks

Trial Locations

Locations (1)

Isfahan University of Medical Sciences; 🇮🇷 Isfahan, Iran, Islamic Republic of