The aim of this study is effects of magnesium supplementation on liver enzymea,lipid profile and Fasting Blood Sugare.
70 Men and women 18-59 years with fatty liver and Alanine amino Transferase equal or higher than 40, allocated into intervention and control groups and respectively recieved magnesium and placebo.It is randomized and double blind trial. exclusion criteria are kidny diseases; chronic lung disease; other hepatic disease and alcoholism. variables are Alanin amino Transferase; Aspartat amino Transferase; Low Density Lipoprotein; High Density Lipoprotein; Alkalinphosphatase; Fasting Blood Sugar; Cholesterol; Triglyceride.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201203128753N1
Registration date:2012-03-12, 1390/12/22
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2012-03-12, 1390/12/22
Registrant information
Name
Mahtab Tamimi
Name of organization / entity
Jondishapoor University of Ahvaz
Country
Iran (Islamic Republic of)
Phone
+98 61 1373 8253
Email address
tamimi.m@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Ahvaz Jundi-shapur University of Medical Sciences
Expected recruitment start date
2011-10-23, 1390/08/01
Expected recruitment end date
2012-04-20, 1391/02/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of magnesium supplementation on liver enzymes , lipid profile and fasting blood glucose in patients of non-alcoholic fatty liver disease
Public title
fatty liver and magnesium
Purpose
Treatment
Inclusion/Exclusion criteria
inclusion criteria:adults (men &women)18-59 years with fatty live and Alanine amino Transferase equal or higher than 40.
exclusion criteria:kidny diseases, chronic lung disease, other hepatic disease, alcoholism.
Age
From 18 years old to 59 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
70
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
Ahvaz Jundi-shapur University of Medical Sciences
Street address
Ahvaz Jundi-shapur University of Medical Sciences, Ahvaz, Iran
City
Ahvaz
Postal code
Approval date
2011-09-23, 1390/07/01
Ethics committee reference number
ETH-336
Health conditions studied
1
Description of health condition studied
non-alcoholic fatty liver disease
ICD-10 code
K76.0
ICD-10 code description
NAFLD
Primary outcomes
1
Description
ALT
Timepoint
befor and 3 month after intervention
Method of measurement
photometric
2
Description
AST
Timepoint
befor and 3 month after intervention
Method of measurement
photometric
3
Description
ALP
Timepoint
befor and 3 month after intervention
Method of measurement
photometric
4
Description
TG
Timepoint
befor and 3 month after intervention
Method of measurement
photometric
5
Description
Chol
Timepoint
befor and 3 month after intervention
Method of measurement
photometric
6
Description
LDL
Timepoint
befor and 3 month after intervention
Method of measurement
undirected method with Friedewald
7
Description
HDL
Timepoint
befor and 3 month after intervention
Method of measurement
Enzymatic
8
Description
FBS
Timepoint
befor and 3 month after intervention
Method of measurement
Photometric
Secondary outcomes
1
Description
weight
Timepoint
befor and after 3 month of intervention
Method of measurement
scale
2
Description
waist circumference
Timepoint
befor and 3 month of intervention
Method of measurement
meter
3
Description
hip circumference
Timepoint
befor and 3 month after intervention
Method of measurement
meter
Intervention groups
1
Description
intervention groups:1 capsol of 580 miligrames magnesium oxide in a day for 3 months
Category
Other
2
Description
control groups:1capsol of lactose in aday for 3 months
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
medical clinic
Full name of responsible person
Street address
City
Ahvaz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ahvaz Jondi-shapur University of Medical Sciences
Full name of responsible person
Doctor Mostapha Pheghhi
Street address
Ahvaz Jondi-shapur University of Medical Sciences, Ahvaz, Iran
City
Ahvaz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ahvaz Jondi-shapur 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
Ahvaz Jondi-shapur University of Medical Sciences
Full name of responsible person
Mahtab Tamimi
Position
BS/ MS
Other areas of specialty/work
Street address
Ahvaz Jondi-shapur University of Medical Sciences, Ahvaz, Iran
City
Ahvaz
Postal code
Phone
+98 61 1338 3838
Fax
Email
research@ajums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahvaz Jondi-shapur University of Medical Sciences
Full name of responsible person
Mahtab Tamimi
Position
BS/MS
Other areas of specialty/work
Street address
Ahvaz Jondi-shapur University of Medical Sciences,Ahvaz, Iran
City
Ahvaz
Postal code
Phone
+98 61 1338 3838
Fax
Email
esearch@ajums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Ahvaz Jondi-shapur University of Medical Sciences
Full name of responsible person
Mahtab Tamimi
Position
BS/ MS
Other areas of specialty/work
Street address
Jondi-shapur University of Medical Sciences,Ahvaz, Iran
City
Ahvaz
Postal code
Phone
+98 61 1338 3838
Fax
Email
research@ajums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)