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The effect of treatment of non-alcoholic fatty liver with zucchini in pregnant women on the gestational diabetes

Protocol summary

Study aim
The effect of treatment of non-alcoholic fatty liver with zucchini in pregnant women on the gestational diabetes
Design
In this randomized clinical trial, 60 consecutive pregnant women with non-alcoholic fatty liver, were randomly divided into 2 groups of intervention and control
Settings and conduct
In this randomized clinical trial , 60 consecutive pregnant women with non-alcoholic fatty liverattending to Kosar Obstetrics Clinic in Arak were enrolled. They were randomly divided into 2 groups of intervention and control. The first group received zucchini 100 gr daily plus dietary regimen for 6 weeks and the control group received just dietary regimen
Participants/Inclusion and exclusion criteria
Inclusion criteria: Known cases of non-alcoholic fatty liverwomen with age between 20-35 years. Exclusion: Alcohol users, other chronic hepatic diseases, known cases of Diabetes mellitus under medical treatment
Intervention groups
In Intervention group they used zucchini 100 gram daily plus dietary regimen for 6 weeks and in control group they were just under dietary regimen
Main outcome variables
Pregnancy Diabetes, Liver Enzyme Level, Lipid Profile Level, Fasting Blood Sugar Level, TNFα Level

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20200419047137N1
Registration date: 2020-05-05, 1399/02/16
Registration timing: registered_while_recruiting

Last update: 2020-05-05, 1399/02/16
Update count: 0
Registration date
2020-05-05, 1399/02/16
Registrant information
Name
Anahita Haghjoo jahromi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 86 3277 6065
Email address
anahita.haghjoo88@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-12-22, 1398/10/01
Expected recruitment end date
2020-12-21, 1399/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of treatment of non-alcoholic fatty liver with zucchini in pregnant women on the gestational diabetes
Public title
The effect of treatment of non-alcoholic fatty liver with zucchini in pregnant women on the gestational Diabetes
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age between 20-35 years old Known case of non-alcoholic fatty liver
Exclusion criteria:
Alcohol user Known cases of autoimmune hepatitis, Hepatitis B, Hepatitis C, or other chronic hepatic diseases Known cases of Diabetic Mellitus under treatment Patients who use Vitamin C, Zinc, Mn or the other antioxidants Patients who use Fibrate, Statins, NSAIDs, Amiodarone or Tamoxifen
Age
From 20 years old to 35 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 60
Randomization (investigator's opinion)
Randomized
Randomization description
Simple individual randomization; randomization with envelopes and allocating into two groups A and B. In this method, we select a number of cards or letters as an intervention group and the same ‎number of cards for the control group, then the cards are mixed. One card is taken out and its ‎allocation is registered and the card is returned to the box near other cards. Then the cards ‎are mixed again and we take out another card. This process continues to reach a random sequence ‎according to sample size.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics comittee of Arak University of Medical Sciences
Street address
Imam-Khomeini Boulevard, Taleghani Hospital
City
Arak
Province
Markazi
Postal code
3814156634
Approval date
2019-12-21, 1398/09/30
Ethics committee reference number
IR.ARAKMU.REC.1398.269

Health conditions studied

1

Description of health condition studied
Non-alcoholic Fatty Liver , Gestational Diabetes Mellitus
ICD-10 code
K76.0
ICD-10 code description
Fatty (change of) liver, not elsewhere classified

Primary outcomes

1

Description
Incidence of gestational diabetes
Timepoint
6 weeks
Method of measurement
Glucose Tolerance Test

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Pregnant women with non-alcoholic fatty liver who are on a diet of 100 grams of zucchini daily for 6 weeks.
Category
Treatment - Other

2

Description
Control group: The control group is on a regular diet alone.
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Taleghani Hospital
Full name of responsible person
Anahita Haghjoo Jahromi
Street address
Imam Khomeini Boulevard
City
Arak
Province
Markazi
Postal code
3816149369
Phone
+98 86 3277 6065
Email
Anahita.Haghjoo88@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Dr Alireza Kamali
Street address
Research Deputy, Payambar Azam Complex, Basij square, Sardasht, Arak
City
Arak
Province
Markazi
Postal code
3816149369
Phone
+98 86 3417 3645
Email
alikamaliir@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Arak University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Anahita Haghjoo Jahromi
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Taleghani hospital ,Imam Khomeini Ave, Beside the Gas Department,Arak,Iran
City
Arak
Province
Markazi
Postal code
3816149369
Phone
+98 86 3277 6065
Email
Anahita.Haghjoo88@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Nazila Najdi
Position
Assistant
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Taleghani hospital ,Imam Khomeini Ave, Beside the Gas Department,Arak,Iran
City
Arak
Province
Markazi
Postal code
3816149369
Phone
+98 86 3277 6065
Email
Anahita.Haghjoo88@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Anahita Haghjoo Jahromi
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Taleghani hospital ,Imam Khomeini Ave, Beside the Gas Department,Arak,Iran
City
Arak
Province
Markazi
Postal code
3816149369
Phone
+98 86 3277 6065
Email
Anahita.Haghjoo88@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
When the article is published, the Excel data file will be available.
When the data will become available and for how long
6 months after publishment of article
To whom data/document is available
Public Use
Under which criteria data/document could be used
Academic researchers can request unrecognizable data after the article is published.
From where data/document is obtainable
Dr Nazila Najdi Faculty of Arak University of Medical Sciences Email: n.najdi@arakmu.ac.ir
What processes are involved for a request to access data/document
They have to write email to the professors corresponding. Email:n.najdi@arakmu.ac.ir Estimated time to respond:1 months
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