- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02220036
Effect of Magnesium Supplementation on Patients With Diabetic Nephropathy
August 18, 2014 updated by: Leila Azadbakht, Isfahan University of Medical Sciences
Effect of Magnesium Supplementation on Kidney Function, Insulin Resistance and Metabolic Profile in Patients With Diabetic Nephropathy
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.
Study Overview
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 Type
Interventional
Enrollment (Anticipated)
80
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Ahmad Esmaeilzadeh, Professor
- Phone Number: 0098 3117922776
- Email: esmaillzadeh@hlth.mui.ac.ir
Study Contact Backup
- Name: Mehdi Sadeghian, Bachelor
- Phone Number: 0098 9131017626
- Email: vipmaster1369@gmail.com
Study Locations
-
-
-
Isfahan, Iran, Islamic Republic of
- Isfahan University of Medical Sciences
-
Principal Investigator:
- Ahmad Esmaeilzadeh, professor
-
Contact:
- Ahmad Esmaeizadeh, Professor
- Phone Number: 0098 3117922776
- Email: esmaillzadeh@hlth.mui.ac.ir
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
9 months to 1 year (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Magnesium Oxide
magnesium tablets, 250 milligram magnesium, 12 weeks, every day 1 tablet
|
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.
Other Names:
|
Placebo Comparator: Placebo
Placebo tablets, the same in color, odor and appearance with magnesium tablets, 12 weeks, one tablet every day
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Serum creatinine
Time Frame: 12 weeks
|
12 weeks
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Hemoglobin A1c
Time Frame: 12 weeks
|
12 weeks
|
Fasting Blood Sugar
Time Frame: 12 weeks
|
12 weeks
|
Blood Urine Nitrogen
Time Frame: 12 weeks
|
12 weeks
|
Glomerular Filtration Rate
Time Frame: 12 weeks
|
12 weeks
|
Proteinuria
Time Frame: 12 weeks
|
12 weeks
|
Serum insulin level
Time Frame: 12 weeks
|
12 weeks
|
High Density Lipoprotein
Time Frame: 12 weeks
|
12 weeks
|
Low Density Lipoprotein
Time Frame: 12 weeks
|
12 weeks
|
Very Low Density Lipoprotein
Time Frame: 12 weeks
|
12 weeks
|
Triglyceride
Time Frame: 12 weeks
|
12 weeks
|
Total Cholesterol
Time Frame: 12 weeks
|
12 weeks
|
high sensitive C-Reactive Protein
Time Frame: 12 week
|
12 week
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Study Chair: Ahmad Sadeghian, Professor, Isfahan University of Medical Sciences
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2014
Primary Completion (Anticipated)
August 1, 2014
Study Completion (Anticipated)
October 1, 2014
Study Registration Dates
First Submitted
August 18, 2014
First Submitted That Met QC Criteria
August 18, 2014
First Posted (Estimate)
August 19, 2014
Study Record Updates
Last Update Posted (Estimate)
August 19, 2014
Last Update Submitted That Met QC Criteria
August 18, 2014
Last Verified
August 1, 2014
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 198476
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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