Clinical trial of the effect of combined vitamin E and zinc supplementation compared with the placebo on metabolic profiles and gene expression related to insulin and lipid in women with gestational diabetes mellitus
Objective: The aim of this study is to determine the effects of combined vitamin E and zinc supplementation on metabolic profiles and gene expression related to insulin and lipid in patients with gestational diabetes mellitus.
Design
Study design: Randomized double-blind placebo-controlled trial. Randomization will be done by the use of computer-generated random numbers. Patients will be assigned into two groups to receive combined vitamin E and zinc supplement (n=30) or placebo (n=30).
Settings and conduct
Among patients with gestational diabetes referred to Naghavi Clinic affiliated to Kashan University of Medical Sciences, 60 patients will be selected according to inclusion and exclusion criteria. Participants, investigators or the assessors of the outcomes are unaware of the study groups. Supplements and placebos are similar in shape and size. Fasting blood samples will be taken at baseline and 6 weeks after the intervention. At the beginning and the end of the intervention: 6 weeks.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Patients with gestational diabetes aged 18 to 40 years. Exclusion criteria: Unwillingness to cooperate.
Intervention groups
Intervention group: 400 IU vitamin E (Zahravi, Tabriz, Iran) and 30 mg elemental zinc (Donyaye Behdasht, Tehran, Iran) daily for 6 weeks orally. Control group: Placebo (Barij Essence, Kashan, Iran), daily for 6 weeks orally.
Main outcome variables
Outcomes: Markers of insulin metabolism (primary outcomes) and lipid profile and gene expression related to insulin and lipid (secondary outcomes) will be quantified at study baseline and end-of-trial.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20170513033941N26
Registration date:2018-01-07, 1396/10/17
Registration timing:retrospective
Last update:2018-01-07, 1396/10/17
Update count:1
Registration date
2018-01-07, 1396/10/17
Registrant information
Name
Mohammadreza Sharif
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 5546 3378
Email address
ostadmohammadi-vr@kaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-11-27, 1396/09/06
Expected recruitment end date
2018-01-05, 1396/10/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Clinical trial of the effect of combined vitamin E and zinc supplementation compared with the placebo on metabolic profiles and gene expression related to insulin and lipid in women with gestational diabetes mellitus
Public title
Effect of combined vitamin E and zinc supplementation in treatment of gestational diabetes mellitus
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Inclusion criteria: Patients with gestational diabetes mellitus.
Individuals aged 18 to 40 years.
Exclusion criteria:
Exclusion criteria: Unwillingness to cooperate.
Age
From 18 years old to 40 years old
Gender
Female
Phase
2
Groups that have been masked
Participant
Investigator
Outcome assessor
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization will be done by the use of computer-generated random numbers.
Blinding (investigator's opinion)
Double blinded
Blinding description
Participants, investigators or the assessors of the outcomes are unaware of the study groups.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of National Institute for Medical Research Development of Iran (NIMAD)
Street address
National Institute for Medical Research Development of Iran, Fatemi Avenue, Tehran
City
Tehran
Province
Tehran
Postal code
۱۴۱۹۶۹۳۱۱۱
Approval date
2017-11-26, 1396/09/05
Ethics committee reference number
IR.NIMAD.REC.1396.133
Health conditions studied
1
Description of health condition studied
Gestational diabetes mellitus
ICD-10 code
O24.9
ICD-10 code description
Unspecified diabetes mellitus in pregnancy, childbirth and the puerperium
Primary outcomes
1
Description
Insulin
Timepoint
At the beginning of the study and after 6 weeks of intervention
Method of measurement
Elisa kit
2
Description
Insulin resistance
Timepoint
At the beginning of the study and after 6 weeks of intervention
Method of measurement
Calculation using HOMA formula
Secondary outcomes
1
Description
Total cholesterol
Timepoint
At the beginning of the study and after 6 weeks of intervention
Method of measurement
Enzymatic kit
2
Description
HDL
Timepoint
At the beginning of the study and after 6 weeks of intervention
Method of measurement
Enzymatic kit
3
Description
Triglycerides
Timepoint
At the beginning of the study and after 6 weeks of intervention
Method of measurement
Enzymatic kit
4
Description
Expressed levels of PPAR-γ gene
Timepoint
At the beginning of the study and after 6 weeks of intervention
Method of measurement
PCR
5
Description
Expressed levels of GLUT-1 gene
Timepoint
At the beginning of the study and after 6 weeks of intervention
Method of measurement
PCR
6
Description
Expressed levels of Lp(a) gene
Timepoint
At the beginning of the study and after 6 weeks of intervention
Method of measurement
PCR
7
Description
Expressed levels of Ox-LDL gene
Timepoint
At the beginning of the study and after 6 weeks of intervention
Method of measurement
PCR
Intervention groups
1
Description
Intervention group: 400 IU vitamin E (Zahravi, Tabriz, Iran) and 30 mg elemental zinc (Donyaye Behdasht, Tehran, Iran) daily for 6 weeks orally.
Category
Treatment - Drugs
2
Description
Control group: Placebo (Barij Essence, Kashan, Iran), daily for 6 weeks orally.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Naghavi Clinic
Full name of responsible person
Mansoreh Samimi
Street address
Shahid Rajaee Avenue, Kashan
City
Kashan
Province
Isfehan
Postal code
8115187159
Phone
+98 31 4446 0180
Fax
Email
samimi_m@kaums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
National Institute for Medical Research Development of Iran (NIMAD)
Full name of responsible person
Dr. Reza Malekzadeh
Street address
National Institute for Medical Research Development of Iran, Fatemi Avenue, Tehran
City
Tehran
Province
Tehran
Postal code
۱۴۱۹۶۹۳۱۱۱
Phone
+98 21 6693 8037
Email
malek@tums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
National Institute for Medical Research Development of Iran (NIMAD)
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
Kashan University of Medical Sciences
Full name of responsible person
Zatollah Asemi
Position
Nutritionist
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Ghotbe Ravandi Boulevard, Kashan
City
Kashan
Province
Isfehan
Postal code
8115187159
Phone
+98 31 5546 3378
Fax
Email
asemi_z@kaums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Zatollah Asemi
Position
Nutritionist
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Ghotbe Ravandi Boulevard, Kashan
City
Kashan
Province
Isfehan
Postal code
8115187159
Phone
+98 31 5546 3378
Fax
Email
asemi_z@kaums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Zatollah Asemi
Position
Nutritionist
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Ghotbe Ravandi Boulevard, Kashan
City
Kashan
Province
Isfehan
Postal code
8115187159
Phone
+98 31 5546 3378
Fax
Email
asemi_z@kaums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available