The effect of thiamine supplementation on biomarkers of inflammation, oxidative stress and its related gene expression in patients with gestational diabetes
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General information
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The updating process was done before publishing the paper to correct the registration information.
The updating process was done before publishing the paper to correct the registration information.
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Recruitment centers
#1
Name of recruitment center - English: Gynecology clinic
Name of recruitment center - Persian: کلینیک زنان
Full name of responsible person - English: Dr. Farzaneh Amini
Full name of responsible person - Persian: دکتر فرزانه امینی
Street address - English: Ghotbe Ravandi Boulevard, Kashan
Street address - Persian: کاشان، بلوار قطب راوندی
City - English: Kashan
City - Persian: کاشان
Province: Isfehan
Country: Iran (Islamic Republic of)
Postal code: 8115187159
Phone: +98 31 5554 2999
Fax:
Email: amini.f@gmail.com
Web page address:
Name of recruitment center - English: Naghavi gynecology clinic
Name of recruitment center - Persian: کلینیک زنان نقوی
Full name of responsible person - English: Dr. Zohreh Tabassi
Full name of responsible person - Persian: دکتر زهره طبسی
Street address - English: Shahid Rajaee street, Kashan
Street address - Persian: کاشان، خیابان شهید رجایی
City - English: Kashan
City - Persian: کاشان
Province: Isfehan
Country: Iran (Islamic Republic of)
Postal code: 8115187159
Phone: +98 31 5545 1515
Fax:
Email: tabassi_z@yahoo.com.sg
Web page address:
Name of recruitment center - English: GynecologyNaghavi gynecology clinic Name of recruitment center - Persian: کلینیک زنان نقوی Full name of responsible person - English: Dr. Farzaneh AminiZohreh Tabassi Full name of responsible person - Persian: دکتر فرزانه امینیزهره طبسی Street address - English: Ghotbe Ravandi BoulevardShahid Rajaee street, Kashan Street address - Persian: کاشان، بلوار قطب راوندیخیابان شهید رجایی City - English: Kashan City - Persian: کاشان Province: Isfehan Country: Iran (Islamic Republic of) Postal code: 8115187159 Phone: +98 31 5554 29995545 1515 Fax: Email: amini.ftabassi_z@gmail.comyahoo.com.sg Web page address:
Protocol summary
Study aim
Objective: The aim of this study is to determine the effects of thiamine supplementation on inflammatory factors, oxidative stress biomarkers and its related gene expression 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 thiamine supplement (n=30) or placebo (n=30).
Settings and conduct
Among patients with gestational diabetes referred to gynecology and obstetric 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. Intervention period: 6 weeks.
Participants/Inclusion and exclusion criteria
Inclusion criteria: patients with gestational diabetes mellitus; aged 18 to 40 years. Exclusion criteria: taking any supplements before the intervention.
Intervention groups
Intervention group: 100 mg thiamine (Shafa Pharmaceutical Company, Karaj, Iran) daily for 6 weeks orally. Control group: Placebo (Barij Essence, Kashan, Iran), daily for 6 weeks orally.
Main outcome variables
Outcomes: hs-CRP (primary outcome) and oxidative stress biomarkers and its related gene expression (secondary outcomes) will be quantified at study baseline and end-of-trial.
General information
Reason for update
The updating process was done before publishing the paper to correct the registration information.
Acronym
IRCT registration information
IRCT registration number:IRCT20170513033941N58
Registration date:2019-05-24, 1398/03/03
Registration timing:registered_while_recruiting
Last update:2020-06-06, 1399/03/17
Update count:1
Registration date
2019-05-24, 1398/03/03
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
2019-04-24, 1398/02/04
Expected recruitment end date
2019-05-25, 1398/03/04
Actual recruitment start date
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Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of thiamine supplementation on biomarkers of inflammation, oxidative stress and its related gene expression in patients with gestational diabetes
Public title
The effect of thiamine supplementation in the treatment of gestational diabetes
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with gestational diabetes mellitus
Individuals aged 18 to 40 years old
Exclusion criteria:
Overt diabetes mellitus
Taking any supplements before the intervention
Unwillingness to cooperate
Age
From 18 years old to 40 years old
Gender
Female
Phase
3
Groups that have been masked
Participant
Investigator
Outcome assessor
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
To decrease potential confounding effects, all participants will have stratified randomization according to BMI (<25 and ≥25 kg/m2) and age (<30 and ≥30 y). Then, participants in each block will be randomly allocated into two treatment groups to take either supplements or placebo. Randomization will be done by the use of computer software.
Blinding (investigator's opinion)
Double blinded
Blinding description
Randomization and allocation will be concealed from the researchers and participants until the final analyses are completed. Another person at the gynecology and obstetric clinic, who is not involved in the trial and not aware of random sequences, will be assigned the participants to the numbered bottles of capsules
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
Isfehan
Postal code
1419693111
Approval date
2019-04-23, 1398/02/03
Ethics committee reference number
IR.NIMAD.REC.1398.035
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
Hs-CRP
Timepoint
At the beginning of the study and after 6 weeks of intervention
Method of measurement
Elisa kit
Secondary outcomes
1
Description
Nitric oxide
Timepoint
At the beginning of the study and after 6 weeks of intervention
Method of measurement
Spectrophotometry
2
Description
Malondialdehyde
Timepoint
At the beginning of the study and after 6 weeks of intervention
Method of measurement
Spectrophotometry
3
Description
Glutathione
Timepoint
At the beginning of the study and after 6 weeks of intervention
Method of measurement
Spectrophotometry
4
Description
Total antioxidant capacity
Timepoint
At the beginning of the study and after 6 weeks of intervention
Method of measurement
Spectrophotometry
5
Description
Expressed levels of IL-1 gene
Timepoint
At the beginning of the study and after 6 weeks of intervention
Method of measurement
RT-PCR
6
Description
Expressed levels of TGF-beta gene
Timepoint
At the beginning of the study and after 6 weeks of intervention
Method of measurement
RT-PCR
7
Description
Expressed levels of VEGF gene
Timepoint
At the beginning of the study and after 6 weeks of intervention
Method of measurement
RT-PCR
8
Description
Expressed levels of TNF gene
Timepoint
At the beginning of the study and after 6 weeks of intervention