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 milligram per deciliter and proteinuria 30-300 milligram per deciliter (micro-albuminuria) and Glomerular Filtration Rate more than 90 milliliter per minute 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.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201404271485N12
Registration date:2014-05-18, 1393/02/28
Registration timing:registered_while_recruiting
Last update:
Update count:1
Registration date
2014-05-18, 1393/02/28
Registrant information
Name
Ahmad Esmaillzadeh
Name of organization / entity
Department of Nutrition, School of Public Health, Isfahan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 1792 2791
Email address
esmaillzadeh@hlth.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Isfahan University of Medical Sciences
Expected recruitment start date
2014-04-22, 1393/02/02
Expected recruitment end date
2015-04-22, 1394/02/02
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of magnesium supplementation on kidney function, insulin resistance and metabolic profile in patients with diabetic nephropathy
Public title
Effect of magnesium supplementation on improvement of patients with diabetic nephropathy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: More than 18 years old; Diabetic nephropathy; Blood glucose more than 126 milligram per deciliter; Proteinuria between 30 to 300 milligram per deciliter (micro-albuminuria); Glomerular Filtration Rate more than 90 milliliter per minute; Not having hypothyroidism and hyperthyroidism; Not having any urine duct infection; Not having any feverish infection; Not using cigarette or other drugs; Not having liver disease; Not having cancer; Not having any inflammatory disease; Not losing weight more than 4 kilogram during last 3 months; Not using any magnesium-rich supplement
Exclusion criteria: Changing medicine doses; failure to adherence (using less than 75 percent of medicines)
Age
From 18 years old to 80 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethical Committee of Isfahan University of Medical Sciences
Street address
Isfahan University of Medical Sciences, Hezar Jerib Ave, Isfahan
City
Isfahan
Postal code
Approval date
2014-04-19, 1393/01/30
Ethics committee reference number
189091
Health conditions studied
1
Description of health condition studied
Diabetes
ICD-10 code
N08.3
ICD-10 code description
Diabetic nephropathy
Primary outcomes
1
Description
Serum Creatinine
Timepoint
Baseline, week 12
Method of measurement
Commercial kit
Secondary outcomes
1
Description
Blood Urine Nitrogen
Timepoint
Baseline, week 12
Method of measurement
Commercial kits
2
Description
Glomerular Filtration Rate
Timepoint
Baseline, week 12
Method of measurement
commercial kits
3
Description
Proteinuria
Timepoint
Baseline, week 12
Method of measurement
Methyl benzatonium chloride method
4
Description
Fasting Blood Sugar
Timepoint
Baseline, week 12
Method of measurement
Commercial kits
5
Description
Hemoglubin A1c
Timepoint
Baseline, week 12
Method of measurement
High-Performance Liquid Chromatography
6
Description
Serum insulin
Timepoint
Baseline, week 12
Method of measurement
Enzyme-Linked Immunosorbent Assay
7
Description
High Density Lipoprotein
Timepoint
Baseline, week 12
Method of measurement
Commercial kits
8
Description
Low Density Lipoprotein
Timepoint
Baseline, week 12
Method of measurement
Commercial kits
9
Description
Very Low Density Lipoprotein
Timepoint
Baseline, week 12
Method of measurement
Commercial kits
10
Description
Triglyceride
Timepoint
Baseline, week 12
Method of measurement
Commercial kits
11
Description
Total Cholesterol
Timepoint
Baseline, week 12
Method of measurement
Commercial kits
12
Description
C-Reactive Protein
Timepoint
Baseline, week 12
Method of measurement
Enzyme-Linked Immunosorbent Assay
Intervention groups
1
Description
Magnesium supplement, each tablet contains 250 mg magnesium oxide, 1 time a day for 12 weeks
Category
Treatment - Drugs
2
Description
Placebo, similar color, odor and appearance to magnesium supplement, 1 time a day for 12 weeks
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Isfahan University of Medical Sciences
Full name of responsible person
Ahmad Esmaeilzadeh
Street address
College of Nutrition, Isfahan University of Medical Sciences, Hezar jerib Avenue, Isfahan, Iran
City
Isfahan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Isfahan University of medical sciences
Full name of responsible person
Payman Adibi
Street address
Research Assistance, Isfahan University of Medical sciences, Av. Hezarjerib, Isfahan, Iran
City
Isfahan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Isfahan University of medical sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Ahmad Esmaeilzade
Position
Associate Professor
Other areas of specialty/work
Street address
College of Nutrition, Isfahan University of Medical Sciences, Hezar jerib Avenue, Isfahan, Iran
City
Isfahan
Postal code
Phone
+98 31 1792 2776
Fax
Email
esmaillzadeh@hlth.mui.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Department of Community Nutrition, School of Nutrition and Food Science, Isfahan University of Medic
Full name of responsible person
Ahmad Esmaeilzade
Position
Associate Professor
Other areas of specialty/work
Street address
College of Nutrition, Isfahan University of Medical Sciences, Hezar jerib Avenue, Isfahan
City
Isfahan
Postal code
Phone
+98 31 1792 2776
Fax
Email
esmaillzadeh@hlth.mui.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
College of Nutrition, Isfahan University of Medical Sciences
Full name of responsible person
Mehdi Sadeghian
Position
Bachelor
Other areas of specialty/work
Street address
Isfahan University of Medical Sciences, Hezar jerib Avenue, Isfahan
City
Isfahan
Postal code
Phone
+31 17922720
Fax
Email
vipmaster1369@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)