Effect of Magnesium Supplementation on Patients With Diabetic Nephropathy

Isfahan University of Medical Sciences

Status: Unknown

Conditions: Diabetes

Treatments: Dietary Supplement: Magnesium Oxide

Study type: Interventional

Funder types: Other

Identifiers

NCT02220036

198476

Details and patient eligibility

About

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.

Full 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).

Enrollment: 80 estimated patients

Sex: All

Ages: 9 to 12 months old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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80 participants in 2 patient groups, including a placebo group

Magnesium Oxide

Active Comparator group

Description:

magnesium tablets, 250 milligram magnesium, 12 weeks, every day 1 tablet

Treatment:

Dietary Supplement: Magnesium Oxide

Placebo

Placebo Comparator group

Description:

Placebo tablets, the same in color, odor and appearance with magnesium tablets, 12 weeks, one tablet every day