Main
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
|
ClinicalTrials.gov |
Last refreshed on:
|
19 February 2015 |
Main ID: |
NCT02220036 |
Date of registration:
|
18/08/2014 |
Prospective Registration:
|
No |
Primary sponsor: |
|
Public title:
|
Effect of Magnesium Supplementation on Patients With Diabetic Nephropathy
|
Scientific title:
|
Effect of Magnesium Supplementation on Kidney Function, Insulin Resistance and Metabolic Profile in Patients With Diabetic Nephropathy |
Date of first enrolment:
|
June 2014 |
Target sample size:
|
80 |
Recruitment status: |
Not yet recruiting |
URL:
|
http://clinicaltrials.gov/show/NCT02220036 |
Study type:
|
Interventional |
Study design:
|
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
|
Phase:
|
N/A
|
|
Countries of recruitment
|
Iran, Islamic Republic of
| | | | | | | |
Contacts
|
Name:
|
Ahmad Sadeghian, Professor |
Address:
|
|
Telephone:
|
|
Email:
|
|
Affiliation:
|
Isfahan University of Medical Sciences |
|
Name:
|
Ahmad Esmaeilzadeh, Professor |
Address:
|
|
Telephone:
|
3117922776 |
Email:
|
esmaillzadeh@hlth.mui.ac.ir |
Affiliation:
|
|
|
Name:
|
Ahmad Esmaeizadeh, Professor |
Address:
|
|
Telephone:
|
3117922776 |
Email:
|
esmaillzadeh@hlth.mui.ac.ir |
Affiliation:
|
|
|
Key inclusion & exclusion criteria
|
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
Age minimum:
9 Months
Age maximum:
12 Months
Gender:
Both
|
Health Condition(s) or Problem(s) studied
|
Diabetes
|
Intervention(s)
|
Dietary Supplement: Magnesium Oxide
|
Primary Outcome(s)
|
Serum creatinine
[Time Frame: 12 weeks]
|
Secondary Outcome(s)
|
Hemoglobin A1c
[Time Frame: 12 weeks]
|
Total Cholesterol
[Time Frame: 12 weeks]
|
Proteinuria
[Time Frame: 12 weeks]
|
Fasting Blood Sugar
[Time Frame: 12 weeks]
|
Serum insulin level
[Time Frame: 12 weeks]
|
Blood Urine Nitrogen
[Time Frame: 12 weeks]
|
Glomerular Filtration Rate
[Time Frame: 12 weeks]
|
Low Density Lipoprotein
[Time Frame: 12 weeks]
|
high sensitive C-Reactive Protein
[Time Frame: 12 week]
|
Triglyceride
[Time Frame: 12 weeks]
|
High Density Lipoprotein
[Time Frame: 12 weeks]
|
Very Low Density Lipoprotein
[Time Frame: 12 weeks]
|
Source(s) of Monetary Support
|
Please refer to primary and secondary sponsors
|
Results
|
Results available:
|
|
Date Posted:
|
|
Date Completed:
|
|
URL:
|
|
|
|