Effect of Magnesium Supplementation on Patients With Diabetic Nephropathy

NCT ID: NCT02220036

Last Updated: 2014-08-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-06-30

Study Completion Date

2014-10-31

Brief Summary

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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

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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).

Conditions

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Diabetes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Magnesium Oxide

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

Group Type ACTIVE_COMPARATOR

Magnesium Oxide

Intervention Type DIETARY_SUPPLEMENT

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.

Placebo

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

Group Type PLACEBO_COMPARATOR

No interventions assigned to this group

Interventions

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Magnesium Oxide

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.

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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21 Century company

Eligibility Criteria

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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
Minimum Eligible Age

9 Months

Maximum Eligible Age

12 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Isfahan University of Medical Sciences

OTHER

Sponsor Role lead

Responsible Party

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Leila Azadbakht

Effect of Magnesium Supplementation on Kidney Function, Insulin Resistance and Metabolic Profile in Patients With Diabetic Nephropathy

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ahmad Sadeghian, Professor

Role: STUDY_CHAIR

Isfahan University of Medical Sciences

Locations

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Isfahan University of Medical Sciences

Isfahan, Isfahan, Iran

Site Status

Countries

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Iran

Central Contacts

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Ahmad Esmaeilzadeh, Professor

Role: CONTACT

3117922776 ext. 0098

Mehdi Sadeghian, Bachelor

Role: CONTACT

9131017626 ext. 0098

Facility Contacts

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Ahmad Esmaeizadeh, Professor

Role: primary

3117922776 ext. 0098

Other Identifiers

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198476

Identifier Type: -

Identifier Source: org_study_id

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