The evaluation of the effect of Magnesium Oxide on Improvement of Carotid intima media Thickness in hemodialysis patients in Alzahra & Khorshid hospitals in 1388-1389
In end stage renal disease the lack of kidney function efficiency lead to toxic substances accumulate in the body, and patients should use kidney replacement treatments to dispose toxic agents frequently via hemodialysis. In these patients, inflammatory reaction lead to an increase in the frequency of vascular disease, especially atherosclerosis so the most important cause of mortality in these patients are heart failure and cardiovascular events. The ways in which the inflammatory process can delay or improve the process, will be able to improve the disease and longer the life of these patients. Use of magnesium supplements as one of the methods of postponing this process is considered. Measurment the thickness of media and intima of carotid with Doppler ultrasound is a valid method for assessment of atherosclerosis.In this study, patients with ESRD that are on hemodialysis at least 3 months, over 18 years old, witout heart failure class 4 or CABG & transplantation plan, noncompliance or magnesium level more than 4mg/dl, recieve magnesium oxide in Alzahra hospital. In our study we examine 27 patients in drug group & 27 patients in placebo group for 6 months and measure carotid IMT prior and after study.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT138808202370N4
Registration date:2010-04-24, 1389/02/04
Registration timing:retrospective
Last update:
Update count:0
Registration date
2010-04-24, 1389/02/04
Registrant information
Name
Mojgan Mortazavi
Name of organization / entity
Isfahan university of medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 1260 2593
Email address
m_mortazavi@med.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Isfahan University of Medical Sciences, Vice Chancellor for Research
Expected recruitment start date
2009-08-22, 1388/05/31
Expected recruitment end date
2010-02-19, 1388/11/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The evaluation of the effect of Magnesium Oxide on Improvement of Carotid intima media Thickness in hemodialysis patients in Alzahra & Khorshid hospitals in 1388-1389
Public title
The effect of Magnesium Oxide on Improvement of Carotid intima media Thickness in hemodialysis patients
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusions:
1- Age >= 18
2- Not having class IV heart failure
3- No history of CABG
4- No history of recent chemotherapy for malignancy
5- Serum PTH > 100
6- Serum Mg > 1.6 < 4 mg/dl
7- Not consuming drugs containing Mg, Ca Chanel Blockers, Chalsiteriol, during 3 months before study
8- Patients with ESRD on maintenance hemodialysis (> 3 mo)
9- Not having uncontrolled HTN
10- Not being in transplantation schedule in the following 6 months
Exclusions:
1- No compliance
2- Severe side effects
3- Serum Mg > 4 mg/dl
4- Transplantation
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:
54
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
Isfahan University of Medical Sciences
Street address
Vice Chancellor for Research, Isfahan University of Medical Sciences
City
Isfahan
Postal code
Approval date
2017-11-21, 1396/08/30
Ethics committee reference number
388128
Health conditions studied
1
Description of health condition studied
End Stage Renal Disease
ICD-10 code
N18.0
ICD-10 code description
End stage renal disease
Primary outcomes
1
Description
Carotid Intima Media Thickness
Timepoint
Before & After Intervention
Method of measurement
Ultrasound Scan
Secondary outcomes
1
Description
Serum Ca
Timepoint
Before & After Intervention
Method of measurement
Autoanalyser
2
Description
serum phsphorus
Timepoint
Before & After Intervention
Method of measurement
Autoanalyser
3
Description
serum albumin
Timepoint
Before & After Intervention
Method of measurement
Autoanalyser
4
Description
serum PTH
Timepoint
Before & After Intervention
Method of measurement
Gama Counter
5
Description
serum magnesium
Timepoint
Before, monthly & After Intervention
Method of measurement
Autoanalyser
6
Description
serum TG
Timepoint
Before & After Intervention
Method of measurement
Autoanalyser
7
Description
serum total cholestrol
Timepoint
Before & After Intervention
Method of measurement
Autoanalyser
8
Description
serum HDL
Timepoint
Before & After Intervention
Method of measurement
Autoanalyser
9
Description
serum LDL
Timepoint
Before & After Intervention
Method of measurement
Autoanalyser
10
Description
serum bicarbonate
Timepoint
Before & After Intervention
Method of measurement
Autoanalyser
11
Description
serum CRP
Timepoint
befoe & after intervention
Method of measurement
ELISA
Intervention groups
1
Description
Tab Magnesium Oxide 440mg every two days for 6 months.
Category
Treatment - Drugs
2
Description
Placebo pill the same as intervention group
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Hemodialysis Unit, Alzahra Hospital
Full name of responsible person
dr firooze moinzadeh
Street address
City
Isfahan
2
Recruitment center
Name of recruitment center
Hemodialysis Unit, Khorshid Hospital
Full name of responsible person
dr firooze moinzadeh
Street address
City
Isfahan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Vice Chancellor for Research
Street address
Vice Chancellor for Research, Isfahan University of Medical Sciences
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
Dr. Mojgan Mortazavi
Position
Assistant Prof. Nephrology
Other areas of specialty/work
Street address
Internal Medicine Unit, School of Medicine, Isfahan University of Medical Sciences
City
Isfahan
Postal code
Phone
+98 31 1625 5555
Fax
Email
m_mortazavi@med.mui.ac.ir, mojgan520@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Dr. Mojgan Mortazavi
Position
Assistant Prof. Nephrology
Other areas of specialty/work
Street address
Internal Medicine Unit, School of Medicine, Isfahan University of Medical Sciences
City
Isfahan
Postal code
Phone
+98 31 1625 5555
Fax
Email
m_mortazavi@med.mui.ac.ir, mojgan520@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Firooze Moinzadeh
Position
Internal Medicine Resident
Other areas of specialty/work
Street address
Department of Nephrology, Alzahra Hospital
City
Isfahan
Postal code
Phone
+98 31 1628 3356
Fax
Email
moinzade@resident.mui.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)