he effect of combined magnesium and vitamin E supplementation on metabolic profiles in patients of coronary artery bypass grafting (CABG) candidate
Design
This study is clinical trial and double blind.60 patients with CABG candidate in Amiralmomenin hospital will enter.
Settings and conduct
This study is clinical trial and double blind.60 patients with CABG candidate in Amiralmomenin hospital will enter. The patient is not aware of the treatment received.Participant and Analyzer are blind (double blind).
Participants/Inclusion and exclusion criteria
Inclusion criteria: Patients candidate for CABG surgery; aged 40-85 years; no smoking; elective patients
Exclusion criteria: death; patients who are more than 8 hours after intubation; patients who are brought back to the operating room due to bleeding
Intervention groups
We use a supplement of magnesium 250 milligram (21st century, USA) daily for one week for 4 weeks of intervention.
We used vitamin E supplements with a dose of 400 IU (Zahra company )daily for one week for 4 weeks after intervention
We used (Contains starch for magnesium and paraffin for vitamin E) with characteristics of the supplements in terms of color, shape and other design specifications, and the number of supplements for 4 weeks of intervention.
Main outcome variables
Effect of supplementation of magnesium and vitamin E on glucose, lipid profile and oxidative plasma biomarkers in patients undergoing CABG surgery
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20141209020258N71
Registration date:2018-03-13, 1396/12/22
Registration timing:registered_while_recruiting
Last update:2018-03-13, 1396/12/22
Update count:0
Registration date
2018-03-13, 1396/12/22
Registrant information
Name
Fariba Farokhi
Name of organization / entity
Arak University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 86 3222 2003
Email address
f.farokhi@arakmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-02-09, 1396/11/20
Expected recruitment end date
2020-02-09, 1398/11/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of combined magnesium and vitamin E supplementation on metabolic profiles in patients of coronary artery bypass grafting (CABG) candidate
Public title
The effect of combined magnesium and vitamin E supplementation on metabolic profiles in patients of coronary artery bypass grafting (CABG) candidate
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients candidate for CABG surgery
Aged 40-85 years
No smoking
Elective patients
Exclusion criteria:
death
All patients who are more than 8 hours after intubation.
All patients who are brought back to the operating room due to bleeding
Age
From 40 years old to 85 years old
Gender
Both
Phase
2-3
Groups that have been masked
Participant
Investigator
Data analyser
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
simple randomization with use random numbers
Blinding (investigator's opinion)
Double blinded
Blinding description
The patient is not aware of the treatment received.Participant and Analyzer are blind (double blind).
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee Arak University Of Medical Sciences
Atherosclerosis of coronary artery bypass graft(s), unspecified, with unstable angina pectoris
Primary outcomes
1
Description
blood suger
Timepoint
First and 1 month after intervention
Method of measurement
blood test
2
Description
Fat profile
Timepoint
First and 1 month after intervention
Method of measurement
blood test
3
Description
Oxidative stress biomarkers
Timepoint
First and 1 month after intervention
Method of measurement
blood test
4
Description
Anthropometric indicators
Timepoint
First and 1 month after intervention
Method of measurement
Strip meter
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: We use a supplement of magnesium 250 milligram (21st century, USA) daily for one week for 4 weeks of intervention.
Category
Treatment - Drugs
2
Description
Intervention group: We used vitamin E supplements with a dose of 400 IU (Zahra company )daily for one week for 4 weeks after intervention.
Category
Treatment - Drugs
3
Description
Control group: We used (Contains starch for magnesium and paraffin for vitamin E) with characteristics of the supplements in terms of color, shape and other design specifications, and the number of supplements for 4 weeks of intervention.