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Clinical trial of the effect of probiotic supplementation compared with the placebo on pregnancy outcomes in women with gestational diabetes

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History
# Registration date Revision Id
2 2019-09-23, 1398/07/01 105018
1 2016-11-23, 1395/09/03 6121
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  • Protocol summary

    Objective: The aim of this study is to determine the effects of probiotic supplementation on biomarkers of inflammation and oxidative stress in patients with gestational diabetes. Study design: Parallel double-blind (both patients and researchers) clinical trial. Randomization will be done by the use of computer-generated random numbers. Inclusion criteria: Patients with gestational diabetes aged 18 to 40 years. Exclusion criteria: Unwillingness to cooperate. Population and sample size: Among patients with gestational diabetes referred to Akbarabadi Clinic affiliated to Iran University of Medical Sciences, 60 patients will be selected according to inclusion and exclusion criteria. Intervention: Patients will be assigned into two groups to receive probiotic (n=30) or placebo (n=30) per day. Probiotic and placebos capsules are similar in shape and size. Fasting blood samples will be taken at baseline and 6 weeks after the intervention. At the beginning and end of the intervention: 6 weeks. Outcomes: Biomarkeres of inflammation and oxidative stress will be quantified at study baseline and end-of-trial.
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    هدف: هدف این مطالعه تعیین اثرات مکمل یاری پروبیوتیک بر بیومارکرهای التهاب و استرس اکسیداتیو در بیماران مبتلا به دیابت بارداری است. طراحي انجام مطالعه: کارآزمایی بالینی دو سوکور (هم بیماران و هم محققان) موازی. تصادفی سازی با استفاده ازجدول اعداد تصادفی ایجاد شده توسط کامپیوتر انجام خواهد شد. معیار ورود به مطالعه: بیماران مبتلا به دیابت بارداری در محدوده سنی 18 تا 40 سال. معیار خروج از مطالعه: عدم تمایل به همکاری. حجم نمونه و جمعیت مورد مطالعه: از بین بیماران مبتلا به دیابت بارداری ارجاع شده به کلینیک اکبرآبادی وابسته به دانشگاه علوم پزشکی ایران، 60 بیمار بر اساس معیار های ورود و خروج از مطالعه انتخاب خواهند شد. مداخله مورد مطالعه: بیماران به دو گروه برای دریافت پروبیوتیک (30=n) یا پلاسبو (30=n) روزانه اختصاص داده خواهند شد. کپسول های پروبیوتیک و پلاسبو از نظر شکل و اندازه مشابه هستند. نمونه خون ناشتا در ابتدای مطالعه و 6 هفته بعد از مداخله از بیماران گرفته خواهد شد. زمان مداخله: 6 هفته. پيامدها: بیومارکرهای التهاب و استرس اکسیداتیو در ابتدا و انتهای مداخله اندازه گیری خواهد شد.
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    The aim of this study is to determine the effects of probiotic supplementation on biomarkers of inflammation and oxidative stress in patients with gestational diabetes.
    empty
    هدف این مطالعه تعیین اثرات مکمل یاری پروبیوتیک بر بیومارکرهای التهاب و استرس اکسیداتیو در بیماران مبتلا به دیابت بارداری است.
    empty
    Study design: Parallel double-blind (both patients and researchers) clinical trial. Randomization will be done by the use of computer-generated random numbers.
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    طراحي انجام مطالعه: کارآزمایی بالینی دو سوکور (هم بیماران و هم محققان) موازی. تصادفی سازی با استفاده ازجدول اعداد تصادفی ایجاد شده توسط کامپیوتر انجام خواهد شد.
    empty
    Population and sample size: Among patients with gestational diabetes referred to Akbarabadi Clinic affiliated to Iran University of Medical Sciences, 60 patients will be selected according to inclusion and exclusion criteria.
    empty
    حجم نمونه و جمعیت مورد مطالعه: از بین بیماران مبتلا به دیابت بارداری ارجاع شده به کلینیک اکبرآبادی وابسته به دانشگاه علوم پزشکی ایران، 60 بیمار بر اساس معیار های ورود و خروج از مطالعه انتخاب خواهند شد.
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    Inclusion criteria: Patients with gestational diabetes aged 18 to 40 years. Exclusion criteria: Placenta abruption, pre-eclampsia, eclampsia, hypo and hyperthyroidism, urinary tract infection, smokers, kidney or liver diseases and insulin therapy during intervention
    empty
    معیار ورود به مطالعه: بیماران مبتلا به دیابت بارداری در محدوده سنی 18 تا 40 سال. معیار خروج از مطالعه: سقط جنین، پره اکلامپسی، اکلامپسی، کم کاری و پرکاری تیروئید، عفونت مجاری ادراری، افراد سیگاری، بیماری کبدی و کلیوی و انسولین درمانی حین مداخله.
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    Intervention: Patients will be assigned into two groups to receive probiotic (n=30) or placebo (n=30) per day. Probiotic and placebos capsules are similar in shape and size.
    empty
    مداخله مورد مطالعه: بیماران به دو گروه برای دریافت پروبیوتیک (30=n) یا پلاسبو (30=n) روزانه اختصاص داده خواهند شد. کپسول های پروبیوتیک و پلاسبو از نظر شکل و اندازه مشابه هستند.
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    Outcomes: Inflammatory markers (primary outcomes), and biomarkers of oxidative stress and pregnancy outcomes (secondry outcomes) signaling pathway will be quantified at study baseline and end-of-trial.
    empty
    پيامدها: مارکرهای التهابی (پیامدهای اولیه) و بیومارکرهای استرس اکسیداتیو و پیامدهای بارداری (پیامدهای ثانویه) در ابتدا و انتهای مداخله اندازه گیری خواهد شد.

  • General information

    1
    1
    1
    Patients with gestational diabetes
    Aged 18 to 40 years.
    بیماران مبتلا به دیابت بارداری
    در محدوده سنی 18 تا 40 سال
    Placenta abruption
    Pre-eclampsia
    Eclampsia
    Hypo and hyperthyroidism
    Urinary tract infection
    Smokers
    Kidney or liver diseases
    Insulin therapy during intervention
    سقط جنین
    پره اکلامپسی
    اکلامپسی
    کم کاری و پرکاری تیروئید
    عفونت مجاری ادراری
    افراد سیگاری
    بیماری کبدی و کلیوی
    انسولین درمانی حین مداخله
    Blinding will be conducted both patients and researchers.
    کورسازی هم در بیماران و هم در محققان انجام خواهد گرفت.
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    Randomization will be done by the use of computer-generated random numbers.
    empty
    تصادفی سازی با استفاده ازجدول اعداد تصادفی ایجاد شده توسط کامپیوتر انجام خواهد شد.
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    Participants, investigators or the assessors of the outcomes are unaware of the study groups.
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    شرکت کنندگان و هم محققان یا ارزیابان پیامد از تخصیص گروههای مطالعه بی اطلاعند.
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    empty

  • Secondary outcomes

    #1
    empty
    Newborn's head circumference
    empty
    دور سر نوزادان
    empty
    Delivery time
    empty
    زمان زایمان
    empty
    Tape
    empty
    متر نواری
    #2
    empty
    Newborn's bilirubin
    empty
    بیلی روبین نوزادان تازه متولد شده
    empty
    Delivery time
    empty
    زمان زایمان
    empty
    Enzymatic kit
    empty
    کیت آنزیمی
    #3
    empty
    Apgar score
    empty
    عدد آپگار
    empty
    Delivery time
    empty
    زمان زایمان
    empty
    Clinical observation
    empty
    مشاهده بالینی
    #4
    empty
    Newborns' hypoglycemia
    empty
    هیپوگلیسمی نوزادان تازه متولد شده
    empty
    After delivery
    empty
    بعد زایمان
    empty
    Enzymatic kit
    empty
    کیت آنزیمی
    #5
    empty
    Preterm delivery
    empty
    زایمان زودرس
    empty
    After delivery
    empty
    بعد زایمان
    empty
    Medical record
    empty
    پرونده پزشکی
    #6
    empty
    Maternal pre-eclampsia
    empty
    پری اکلامپسی مادران باردار
    empty
    After delivery
    empty
    بعد زایمان
    empty
    Medical record
    empty
    پرونده پزشکی
    #7
    empty
    Newborns' hospitalization
    empty
    بستری شدن نوزادان تازه متولد شده
    empty
    After delivery
    empty
    بعد زایمان
    empty
    Medical record
    empty
    پرونده پزشکی

  • Intervention groups

    #1
    Control group: Placebo (Barij Essence, Kashan, Iran), daily, for 6 weeks orally.
    Control group: Placebo (Tak Gen Zist, Tehran, Iran), daily, for 6 weeks orally.
    گروه کنترل: پلاسبو (باریج اسانس، کاشان، ایران)، روزانه، به صورت خوراکی برای 6 هفته.
    گروه کنترل: پلاسبو (تک ژن زیست، تهران، ایران)، روزانه، به صورت خوراکی برای 6 هفته.

  • Recruitment centers

    #1
    Name of recruitment center - English: Akbarabadi Clinic
    Name of recruitment center - Persian: کلینیک اکبرآبادی
    Full name of responsible person - English: Maryam Karamali
    Full name of responsible person - Persian: مریم کرمعلی
    Street address - English: Akbarabadi Hospital, Mowlavi Street, Tehran
    Street address - Persian: تهران، خیابان مولوی، بیمارستان اکبرآبادی
    City - English: Tehran
    City - Persian: تهران
    Province:
    Country: Iran (Islamic Republic of)
    Postal code:
    Phone:
    Fax:
    Email:
    Web page address:
    Name of recruitment center - English: Akbarabadi Clinic
    Name of recruitment center - Persian: کلینیک اکبرآبادی
    Full name of responsible person - English: Maryam Karamali
    Full name of responsible person - Persian: مریم کرمعلی
    Street address - English: Akbarabadi Hospital, Mowlavi Street, Tehran
    Street address - Persian: تهران، خیابان مولوی، بیمارستان اکبرآبادی
    City - English: Tehran
    City - Persian: تهران
    Province: Tehran
    Country: Iran (Islamic Republic of)
    Postal code: 1168743514
    Phone: +98 21 5560 6034
    Fax:
    Email: akbarabadihosp@yahoo.com
    Web page address:

  • Sponsors / Funding sources

    #1
    contact.organization_id:
    Name of organization / entity - English: Vice chancellor for research, Iran University of Medical Sciences
    Name of organization / entity - Persian: معاونت پژوهشی دانشگاه علوم پزشکی ایران
    Full name of responsible person - English: Seyed Ali Javad Moosavi
    Full name of responsible person - Persian: سيد علي جواد موسوي
    Street address - English: Vice chancellor for research, Iran University of Medical Sciences, Hemmat Highway, Tehran
    Street address - Persian: تهران، بزرگراه همت، معاونت پژوهشی دانشگاه علوم پزشکی ایران
    City - English: Tehran
    City - Persian: تهران
    Province:
    Country: Iran (Islamic Republic of)
    Postal code:
    Phone:
    Fax:
    Email:
    Web page address:
    contact.organization_id:
    Name of organization / entity - English: Vice chancellor for research, Iran University of Medical Sciences
    Name of organization / entity - Persian: معاونت پژوهشی دانشگاه علوم پزشکی ایران
    Full name of responsible person - English: Seyed Ali Javad Moosavi
    Full name of responsible person - Persian: سيد علي جواد موسوي
    Street address - English: Vice chancellor for research, Iran University of Medical Sciences, Hemmat Highway, Tehran
    Street address - Persian: تهران، بزرگراه همت، معاونت پژوهشی دانشگاه علوم پزشکی ایران
    City - English: Tehran
    City - Persian: تهران
    Province: Tehran
    Country: Iran (Islamic Republic of)
    Postal code: 009886704768
    Phone: +98 21 8670 4768
    Fax:
    Email: PR@iums.ac.ir
    Web page address:
    empty
    Public
    empty
    Domestic
    empty
    Academic

  • Person responsible for general inquiries

    contact.organization_id:
    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English:
    Full name of responsible person - Persian:
    Position - English:
    Position - Persian:
    Latest degree:
    Area of specialty/work:
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English:
    Street address - Persian:
    City - English:
    City - Persian:
    Province:
    Province - English:
    Province - Persian:
    contact.provinces_available:
    Country:
    Postal code:
    Phone:
    Mobile:
    Fax:
    Email:
    Web page address:

    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: Zatollah Asemi
    Full name of responsible person - Persian: ذات اله عاصمی
    Position - English: PhD of Nutrition
    Position - Persian: دکتری تغذیه
    Latest degree: phd
    Area of specialty/work: 34
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: Ghotbe Ravandi Boulevard, Kashan
    Street address - Persian: کاشان، بلوار قطب راوندی
    City - English: Kashan
    City - Persian: کاشان
    Province: Isfehan
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code: 1771844351
    Phone: +98 31 5546 3378
    Mobile: +98 913 361 5446
    Fax:
    Email: asemi_z@kaums.ac.ir
    Web page address:

  • Person responsible for scientific inquiries

    contact.organization_id:
    Name of organization / entity - English: Kashan University of Medical Sciences
    Name of organization / entity - Persian: دانشگاه علوم پزشکی کاشان
    Full name of responsible person - English: Zatollah Asemi
    Full name of responsible person - Persian: ذات اله عاصمی
    Position - English: PhD of Nutrition
    Position - Persian: دکترای تغذیه
    Latest degree:
    Area of specialty/work: 0
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: Ghotbe Ravandi Boulevard, Kashan
    Street address - Persian: کاشان، بلوار قطب راوندی
    City - English: Kashan
    City - Persian: کاشان
    Province:
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code:
    Phone: +98 31 5546 3378
    Mobile: +98 913 361 5446
    Fax:
    Email: asemi_z@kaums.ac.ir; asemi_r@yahoo.com
    Web page address:
    contact.organization_id:
    Name of organization / entity - English: Kashan University of Medical Sciences
    Name of organization / entity - Persian: دانشگاه علوم پزشکی کاشان
    Full name of responsible person - English: Zatollah Asemi
    Full name of responsible person - Persian: ذات اله عاصمی
    Position - English: PhD of Nutrition
    Position - Persian: دکترای تغذیه
    Latest degree: phd
    Area of specialty/work: 34
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: Ghotbe Ravandi Boulevard, Kashan
    Street address - Persian: کاشان، بلوار قطب راوندی
    City - English: Kashan
    City - Persian: کاشان
    Province: Isfehan
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code: 1771844351
    Phone: +98 31 5546 3378
    Mobile: +98 913 361 5446
    Fax:
    Email: asemi_z@kaums.ac.ir
    Web page address:

  • Person responsible for updating data

    contact.organization_id:
    Name of organization / entity - English: Kashan University of Medical Sciences
    Name of organization / entity - Persian: دانشگاه علوم پزشکی کاشان
    Full name of responsible person - English: Zatollah Asemi
    Full name of responsible person - Persian: ذ ات اله عاصمی
    Position - English: PhD of Nutrition
    Position - Persian: دکترای تغذیه
    Latest degree:
    Area of specialty/work: 0
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: Ghotbe Ravandi Boulevard, Kashan
    Street address - Persian: کاشان، بلوار قطب راوندی
    City - English: Kashan
    City - Persian: کاشان
    Province:
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code:
    Phone: +98 31 5546 3378
    Mobile: +98 913 361 5446
    Fax:
    Email: asemi_z@kaums.ac.ir; asemi_r@yahoo.com
    Web page address:
    contact.organization_id:
    Name of organization / entity - English: Kashan University of Medical Sciences
    Name of organization / entity - Persian: دانشگاه علوم پزشکی کاشان
    Full name of responsible person - English: Zatollah Asemi
    Full name of responsible person - Persian: ذ ات اله عاصمی
    Position - English: PhD of Nutrition
    Position - Persian: دکترای تغذیه
    Latest degree: phd
    Area of specialty/work: 34
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: Ghotbe Ravandi Boulevard, Kashan
    Street address - Persian: کاشان، بلوار قطب راوندی
    City - English: Kashan
    City - Persian: کاشان
    Province: Isfehan
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code: 1771844351
    Phone: +98 31 5546 3378
    Mobile: +98 913 361 5446
    Fax:
    Email: asemi_z@kaums.ac.ir
    Web page address:

  • Sharing plan

    undecided
    undecided
    undecided
    undecided
    undecided
    undecided
    undecided
    empty
    Undecided - It is not yet known if there will be a plan to make this available.
    empty
    هنوز تصمیم نگرفته‌ام - برنامه انتشار آن هنوز مشخص نیست.

Protocol summary

Study aim
The aim of this study is to determine the effects of probiotic supplementation on biomarkers of inflammation and oxidative stress in patients with gestational diabetes.
Design
Study design: Parallel double-blind (both patients and researchers) clinical trial. Randomization will be done by the use of computer-generated random numbers.
Settings and conduct
Population and sample size: Among patients with gestational diabetes referred to Akbarabadi Clinic affiliated to Iran University of Medical Sciences, 60 patients will be selected according to inclusion and exclusion criteria.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Patients with gestational diabetes aged 18 to 40 years. Exclusion criteria: Placenta abruption, pre-eclampsia, eclampsia, hypo and hyperthyroidism, urinary tract infection, smokers, kidney or liver diseases and insulin therapy during intervention
Intervention groups
Intervention: Patients will be assigned into two groups to receive probiotic (n=30) or placebo (n=30) per day. Probiotic and placebos capsules are similar in shape and size.
Main outcome variables
Outcomes: Inflammatory markers (primary outcomes), and biomarkers of oxidative stress and pregnancy outcomes (secondry outcomes) signaling pathway will be quantified at study baseline and end-of-trial.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT201611115623N91
Registration date: 2016-11-23, 1395/09/03
Registration timing: retrospective

Last update: 2019-09-25, 1398/07/03
Update count: 1
Registration date
2016-11-23, 1395/09/03
Registrant information
Name
Zatollah Asemi
Name of organization / entity
Kashan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 36 1534 3570
Email address
asemi_z@kaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Iran University of Medical Sciences
Expected recruitment start date
2016-04-07, 1395/01/19
Expected recruitment end date
2016-05-08, 1395/02/19
Actual recruitment start date
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Actual recruitment end date
empty
Trial completion date
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Scientific title
Clinical trial of the effect of probiotic supplementation compared with the placebo on pregnancy outcomes in women with gestational diabetes
Public title
Effect of supplementation in treatment of women with gestational diabetes
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with gestational diabetes Aged 18 to 40 years.
Exclusion criteria:
Placenta abruption Pre-eclampsia Eclampsia Hypo and hyperthyroidism Urinary tract infection Smokers Kidney or liver diseases Insulin therapy during intervention
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
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

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Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Iran University of Medical Sciences
Street address
Vice chancellor for research, Iran University of Medical Sciences, Hemmat Highway, Tehran
City
Tehran
Province
Tehran
Postal code
1449614535
Approval date
2016-04-06, 1395/01/18
Ethics committee reference number
IR.IUMS.REC 1394.9111290001

Health conditions studied

1

Description of health condition studied
Gestational diabetes
ICD-10 code
E28.2
ICD-10 code description
Diabetes mellitus in pregnancy, unspecified

Primary outcomes

1

Description
hs-CRP
Timepoint
At the beginning of the study and after 6 weeks of intervention
Method of measurement
Elisa kit

2

Description
Nitric oxide
Timepoint
At the beginning of the study and after 6 weeks of intervention
Method of measurement
Spectrophotometry

Secondary outcomes

1

Description
Total antioxidant
Timepoint
At the beginning of the study and after 6 weeks of intervention
Method of measurement
Spectrophotometry

2

Description
Glutathione
Timepoint
At the beginning of the study and after 6 weeks of intervention
Method of measurement
Spectrophotometry

3

Description
Malondialdehyde
Timepoint
At the beginning of the study and after 6 weeks of intervention
Method of measurement
Spectrophotometry

4

Description
Newborns' weight
Timepoint
The first 24 h after birth
Method of measurement
Scale

5

Description
Newborns' length
Timepoint
The first 24 h after birth
Method of measurement
Girth measuring tape

6

Description
Newborns' head circumference
Timepoint
The first 24 h after birth
Method of measurement
Girth measuring tape

7

Description
Polyhydramnios
Timepoint
Post-intervention
Method of measurement
Sonography

8

Description
Newborn's head circumference
Timepoint
Delivery time
Method of measurement
Tape

9

Description
Newborn's bilirubin
Timepoint
Delivery time
Method of measurement
Enzymatic kit

10

Description
Apgar score
Timepoint
Delivery time
Method of measurement
Clinical observation

11

Description
Newborns' hypoglycemia
Timepoint
After delivery
Method of measurement
Enzymatic kit

12

Description
Preterm delivery
Timepoint
After delivery
Method of measurement
Medical record

13

Description
Maternal pre-eclampsia
Timepoint
After delivery
Method of measurement
Medical record

14

Description
Newborns' hospitalization
Timepoint
After delivery
Method of measurement
Medical record

Intervention groups

1

Description
Intervention group: Probiotic capsule containing four strains of Lactobacillus acidophilus (2×109 CFU/g), Lactobacillus casei (2×109 CFU/g) and Bifidobacterium bifidum (2×109 CFU/g) (Tak Gen Zist, Tehran, Iran), daily, for 6 weeks orally.
Category
Treatment - Drugs

2

Description
Control group: Placebo (Tak Gen Zist, Tehran, Iran), daily, for 6 weeks orally.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Akbarabadi Clinic
Full name of responsible person
Maryam Karamali
Street address
Akbarabadi Hospital, Mowlavi Street, Tehran
City
Tehran
Province
Tehran
Postal code
1168743514
Phone
+98 21 5560 6034
Email
akbarabadihosp@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research, Iran University of Medical Sciences
Full name of responsible person
Seyed Ali Javad Moosavi
Street address
Vice chancellor for research, Iran University of Medical Sciences, Hemmat Highway, Tehran
City
Tehran
Province
Tehran
Postal code
009886704768
Phone
+98 21 8670 4768
Email
PR@iums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Iran 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
Kashan University of Medical Sciences
Full name of responsible person
Zatollah Asemi
Position
PhD of Nutrition
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Ghotbe Ravandi Boulevard, Kashan
City
Kashan
Province
Isfehan
Postal code
1771844351
Phone
+98 31 5546 3378
Email
asemi_z@kaums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Zatollah Asemi
Position
PhD of Nutrition
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Ghotbe Ravandi Boulevard, Kashan
City
Kashan
Province
Isfehan
Postal code
1771844351
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
PhD of Nutrition
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Ghotbe Ravandi Boulevard, Kashan
City
Kashan
Province
Isfehan
Postal code
1771844351
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
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