Protocol summary
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Study aim
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This study aimed to examine the effect of magnesium supplementation on renal function, insulin resistance and metabolic profiles in patients with diabetic nephropathy.
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Design
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This is a double-blind randomized clinical trial
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Settings and conduct
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urinary albumin to creatinine ratio (UACR) is considered as a key variable and the sample size calculated 80 persons (40 persons for control group and 40 persons for patient group). 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.
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Participants/Inclusion and exclusion criteria
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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.
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Intervention groups
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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.
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Main outcome variables
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metabolic, renal and inflammatory profiles will be measured at the beginning and end of the study as well as anthropometric measurements.
General information
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Reason for update
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT201404271485N12
Registration date:
2014-05-18, 1393/02/28
Registration timing:
prospective
Last update:
2018-01-08, 1396/10/18
Update count:
1
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Registration date
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2014-05-18, 1393/02/28
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Isfahan University of Medical Sciences
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Expected recruitment start date
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2014-04-22, 1393/02/02
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Expected recruitment end date
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2015-04-22, 1394/02/02
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Actual recruitment start date
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2014-10-06, 1393/07/14
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Actual recruitment end date
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2016-04-23, 1395/02/04
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Trial completion date
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empty
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Scientific title
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Effect of magnesium supplementation on kidney function, insulin resistance and metabolic profile in patients with diabetic nephropathy
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Public title
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Effect of magnesium supplementation on improvement of patients with diabetic nephropathy
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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Inclusion criteria:
More than 18 years old
Diabetic nephropathy
Blood glucose more than 126 milligram per decilite
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)
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Age
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From 18 years old to 80 years old
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Gender
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Both
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Phase
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2
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Groups that have been masked
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Sample size
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Target sample size:
80
Actual sample size reached:
80
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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After stratification for age, sex, type and dose of medication and BMI, subjects were randomly assigned to receive either magnesium supplements or placebo.
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Blinding (investigator's opinion)
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Double blinded
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Blinding description
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Placebo was similar in appearance (color, shape, size and packaging) with supplements. Patients were indicated by numbers for principle investigator. Supplement or placebo were handed over the participants by two other health provider not related to the trial.
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Placebo
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Used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2014-04-19, 1393/01/30
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Ethics committee reference number
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189091
Health conditions studied
1
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Description of health condition studied
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Diabetes
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ICD-10 code
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N08.3
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ICD-10 code description
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Diabetic nephropathy
Primary outcomes
1
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Description
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albumin to creatinine ratio (UACR)
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Timepoint
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Baseline, week 12
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Method of measurement
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Commercial kit
Secondary outcomes
1
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Description
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Blood Urine Nitrogen
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Timepoint
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Baseline, week 12
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Method of measurement
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Commercial kits
2
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Description
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Glomerular Filtration Rate
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Timepoint
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Baseline, week 12
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Method of measurement
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commercial kits
3
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Description
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Proteinuria
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Timepoint
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Baseline, week 12
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Method of measurement
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Methyl benzatonium chloride method
4
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Description
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Fasting Blood Sugar
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Timepoint
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Baseline, week 12
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Method of measurement
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Commercial kits
5
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Description
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Hemoglubin A1c
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Timepoint
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Baseline, week 12
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Method of measurement
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High-Performance Liquid Chromatography
6
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Description
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Serum insulin
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Timepoint
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Baseline, week 12
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Method of measurement
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Enzyme-Linked Immunosorbent Assay
7
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Description
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High Density Lipoprotein
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Timepoint
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Baseline, week 12
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Method of measurement
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Commercial kits
8
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Description
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Low Density Lipoprotein
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Timepoint
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Baseline, week 12
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Method of measurement
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Commercial kits
9
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Description
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Very Low Density Lipoprotein
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Timepoint
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Baseline, week 12
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Method of measurement
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Commercial kits
10
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Description
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Triglyceride
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Timepoint
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Baseline, week 12
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Method of measurement
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Commercial kits
11
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Description
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Total Cholesterol
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Timepoint
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Baseline, week 12
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Method of measurement
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Commercial kits
12
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Description
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C-Reactive Protein
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Timepoint
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Baseline, week 12
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Method of measurement
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Enzyme-Linked Immunosorbent Assay
13
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Description
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creatinine
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Timepoint
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Baseline, week 12
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Method of measurement
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Commercial kits
Intervention groups
1
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Description
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Magnesium supplement, each tablet contains 250 mg magnesium oxide, 1 time a day for 12 weeks
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Category
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Treatment - Drugs
2
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Description
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Placebo, similar color, odor and appearance to magnesium supplement, 1 time a day for 12 weeks
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Category
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Treatment - Drugs
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Isfahan University of medical sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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No - There is not a plan to make this available
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Justification/reason for indecision/not sharing IPD
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There is no data sharing agreement from the related organization.
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Study Protocol
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No - There is not a plan to make this available
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Statistical Analysis Plan
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No - There is not a plan to make this available
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Informed Consent Form
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No - There is not a plan to make this available
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Clinical Study Report
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Yes - There is a plan to make this available
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Analytic Code
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No - There is not a plan to make this available
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Data Dictionary
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No - There is not a plan to make this available
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Title and more details about the data/document
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The effect of oral magnesium supplementation on micro-albuminuria and metabolic status of patients with diabetic nephropathy: a double-blind randomized controlled clinical trial
The primary outcome measure only is to be shared
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When the data will become available and for how long
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January 2017
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To whom data/document is available
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for people working in academic institutions
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Under which criteria data/document could be used
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No other criteria are not provided.
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From where data/document is obtainable
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mehdisad69@gmail.com
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What processes are involved for a request to access data/document
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After identification of applicant validity, and getting permission from related organization, the primary outcomes will be sent.
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Comments
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