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General information
Not blinded
Double blinded
notbldoubl
1
1
1
1
1
1
Parallel
Factorial
paralfacto
empty
Randomization was assigned to a random assignment list by a research team member as the only non-blind person. Other members of the research team (including team leader and study coordinator) as well as all participants participated in the random allocation of blind groups and remained blind until the end of the study.In fact, in this study, patients were blinded to use of placebo or supplementation. Also, all of the study subjects were blind except for one group.
Randomization was assigned to a random assignment list by a research team member as the only non-blind person. Other members of the research team (including team leader and study coordinator) as well as all participants participated in the random allocation of blind groups and remained blind until the end of the study.In fact, in this study, patients were blinded to use of placebo or supplementation. Also, all of the study subjects were blind except for one group.
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تصادفی سازی از طریق یک لیست تخصیص تصادفی توسط یکی از اعضای تیم تحقیقاتی به عنوان تنها فرد غیر کور شده به تخصیص صورت گرفت. دیگر اعضای تیم تحقیقاتی (از جمله سرپرست تیم و هماهنگ کننده مطالعه (study coordinator)) و همچنین تمامی افراد شرکت کننده، به تخصیص تصادفی گروه ها کور بودند و تا انتها ی مطالعه کور باقی ماندند.
در واقع در این مطالعه بیماران نسبت به مصرف دارونما و یا مکمل کور شده بودند. همچنین تمامی افراد مطالعه به غیر از یک نفر نسبت به دسته بندی گروه ها کور بودند.
تصادفی سازی از طریق یک لیست تخصیص تصادفی توسط یکی از اعضای تیم تحقیقاتی به عنوان تنها فرد غیر کور شده به تخصیص صورت گرفت. دیگر اعضای تیم تحقیقاتی (از جمله سرپرست تیم و هماهنگ کننده مطالعه (study coordinator)) و همچنین تمامی افراد شرکت کننده، به تخصیص تصادفی گروه ها کور بودند و تا انتها ی مطالعه کور باقی ماندند. در واقع در این مطالعه بیماران نسبت به مصرف دارونما و یا مکمل کور شده بودند. همچنین تمامی افراد مطالعه به غیر از یک نفر نسبت به دسته بندی گروه ها کور بودند.
Intervention groups
#1
Group D = Receptor of Starch Placebo with Miglly Oil
Group D = Receptor of Starch Placebo
Group D = Receptor of Starch Placebo with Miglly Oil
گروه D= دریافت کننده پلاسبو نشاسته به همراه روغن میگلیول
گروه D= دریافت کننده پلاسبو نشاسته
گروه D= دریافت کننده پلاسبو نشاسته به همراه روغن میگلیول
Recruitment centers
#1
Name of recruitment center - English: Imam Khomeini Hospital of Urmia
Name of recruitment center - Persian: بیمارستان امام خمینی ارومیه
Full name of responsible person - English: Dr. Peyvand Mohammadi Endocrinologist
Full name of responsible person - Persian: دکتر پیوند محمدی فوق تخصص غدد
Street address - English: Floor 2, Imam Khomeini Hospital professional clinic (1), Ershad Ave urmia West Azarbgijan
Street address - Persian: خیابان ارشاد، درمانگاه تخصصی شماره 1 بیمارستان امام خمینی، طبقه دوم ارومیه آذربایجان غربی
City - English: Urmia
City - Persian: ارومیه
Province:
Country: Iran (Islamic Republic of)
Postal code:
Phone:
Fax:
Email:
Web page address:
Name of recruitment center - English: Imam Khomeini Hospital of Urmia
Name of recruitment center - Persian: بیمارستان امام خمینی ارومیه
Full name of responsible person - English: Dr. Peyvand Mohammadi Endocrinologist
Full name of responsible person - Persian: دکتر پیوند محمدی فوق تخصص غدد
Street address - English: Floor 2, Imam Khomeini Hospital professional clinic (1), Ershad Ave urmia West Azarbgijan
Street address - Persian: خیابان ارشاد، درمانگاه تخصصی شماره 1 بیمارستان امام خمینی، طبقه دوم ارومیه آذربایجان غربی
City - English: Urmia
City - Persian: ارومیه
Province: West Azarbaijan
Country: Iran (Islamic Republic of)
Postal code: 5715799313
Phone: +98 38 3333 3792
Fax: +98 44 3278 0801
Email: mehdikhakian1371@yahoo.com
Web page address:
Name of recruitment center - English: Imam Khomeini Hospital of Urmia Name of recruitment center - Persian: بیمارستان امام خمینی ارومیه Full name of responsible person - English: Dr. Peyvand Mohammadi Endocrinologist Full name of responsible person - Persian: دکتر پیوند محمدی فوق تخصص غدد Street address - English: Floor 2, Imam Khomeini Hospital professional clinic (1), Ershad Ave urmia West Azarbgijan Street address - Persian: خیابان ارشاد، درمانگاه تخصصی شماره 1 بیمارستان امام خمینی، طبقه دوم ارومیه آذربایجان غربی City - English: Urmia City - Persian: ارومیه Province: West Azarbaijan Country: Iran (Islamic Republic of) Postal code: 5715799313 Phone: +98 38 3333 3792 Fax: +98 44 3278 0801 Email: mehdikhakian1371@yahoo.com Web page address:
Sponsors / Funding sources
#1
contact.organization_id:
Name of organization / entity - English: Urmia University of Medical Sciences
Name of organization / entity - Persian: دانشگاه علوم پزشکی ارومیه
Full name of responsible person - English: Mehdikhakian
Full name of responsible person - Persian: مهدی خاکیان
Street address - English: Nutrition counseling office and diet therapy,Imam Khomeini Hospital, Ershad Ave Urmia West Azarbgijan Iran, Islamic Republic Of
Street address - Persian: خیابان ارشاد، بیمارستان امام خمینی، دفتر مشاوه تغذیه و رژیم درمانی ارومیه آذربایجان غربی ایران
City - English: Urmia
City - Persian: ارومیه
Province:
Country: Iran (Islamic Republic of)
Postal code:
Phone:
Fax:
Email:
Web page address:
contact.organization_id:
Name of organization / entity - English: Urmia University of Medical Sciences
Name of organization / entity - Persian: دانشگاه علوم پزشکی ارومیه
Full name of responsible person - English: Mehdikhakian
Full name of responsible person - Persian: مهدی خاکیان
Street address - English: Nutrition counseling office and diet therapy,Imam Khomeini Hospital, Ershad Ave Urmia West Azarbgijan Iran, Islamic Republic Of
Street address - Persian: خیابان ارشاد، بیمارستان امام خمینی، دفتر مشاوه تغذیه و رژیم درمانی ارومیه آذربایجان غربی ایران
City - English: Urmia
City - Persian: ارومیه
Province: West Azarbaijan
Country: Iran (Islamic Republic of)
Postal code: 5715799313
Phone: +98 44 3223 6151
Fax: +98 44 3278 0801
Email: mehdikhakian1371@yahoo.com
Web page address:
contact.organization_id: Name of organization / entity - English: Urmia University of Medical Sciences Name of organization / entity - Persian: دانشگاه علوم پزشکی ارومیه Full name of responsible person - English: Mehdikhakian Full name of responsible person - Persian: مهدی خاکیان Street address - English: Nutrition counseling office and diet therapy,Imam Khomeini Hospital, Ershad Ave Urmia West Azarbgijan Iran, Islamic Republic Of Street address - Persian: خیابان ارشاد، بیمارستان امام خمینی، دفتر مشاوه تغذیه و رژیم درمانی ارومیه آذربایجان غربی ایران City - English: Urmia City - Persian: ارومیه Province: West Azarbaijan Country: Iran (Islamic Republic of) Postal code: 5715799313 Phone: +98 44 3223 6151 Fax: +98 44 3278 0801 Email: mehdikhakian1371@yahoo.com Web page address:
Protocol summary
Study aim
The aim of this study is evaluate the effect of omega-3 and zinc supplements on inflammatory status, lipid profiles and antioxidant capacity in type 2 diabetic patients.
Design
In this study, 80 patients with type 2 diabetes who were admitted to study at the endocrine clinic of Imam Khomeini Hospital in Urmia were selected. The participants are randomly divided into four intervention and control groups and each participant is assigned a code.
Settings and conduct
This study will be conducted at Urmia University of Medical Sciences for 8 weeks. In this study, 1000 mg of omega-3 (180 mg of eicosapentaenoic acid and 120 mg of deca-hexaenoic acid) and 30 mg of zinc per day will be given.
Participants/Inclusion and exclusion criteria
Inclusion criteria include people with type 2 diabetes without insulin injections. Insulin infusion and kidney problems are among the criteria for withdrawal.
Intervention groups
Patients were randomly will be divided into 3 intervention groups including interventional group with omega-3 (n = 20), interventional group with Zn (n = 20), interventional group omega-3 with zinc (n = 20) and placebo group (n = 20).
Main outcome variables
Lipid profile (total cholesterol; HDL; LDL; triglyceride); inflammatory status (Hs-CRP); total antioxidant capacity (TAC) in this study once at the beginning of the study and once at the end of the study will be evaluated.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20170214032571N2
Registration date:2018-01-13, 1396/10/23
Registration timing:retrospective
Last update:2018-03-11, 1396/12/20
Update count:1
Registration date
2018-01-13, 1396/10/23
Registrant information
Name
Majid Manafi
Name of organization / entity
Urmia University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 32770698
Email address
manafi.m@umsu.ac.ir
Recruitment status
Recruitment complete
Funding source
Support by Urmia University of Medical Sciences
Expected recruitment start date
2016-09-30, 1395/07/09
Expected recruitment end date
2016-11-20, 1395/08/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of supplemental omega-3 and zinc supplementation on inflammation, lipid profiles and antioxidant capacity in type 2 diabetic patients
Public title
The effect of omega-3 and zinc in the treatment of diabetes
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
tendency to Cooperation
Type 2 diabetic patients ; taking metformin or glibenclamide glucose or similar drugs by patients
Age range 18 to 65 years
use of lipid lowering statin drugs and a blood pressure lowering drugs
Exclusion criteria:
Unwillingness to participate in the study
Insulin injection
Do not consume 80% of supplements per course
People with pancreatic cancer and patients receiving steroidal anti-inflammatory drugs (due to secondary hyperglycemia)
severe physical activity
Use of omega-3 and zinc supplementation in the last three months
developing any underlying coronary artery disease and cancer
taking antidepressants (because of interactions with zinc supplementation)
Age
From 18 years old to 65 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
Patients were divided into 4 equal groups of 20 (A total of 80),A , B, C and D,
by using simple randomization method.The study groups included omega-3 (A), zinc (B), omega-3 and zinc (C), and placebo-control group (D).Randomization was assigned to a random assignment list by a research team member.
Blinding (investigator's opinion)
Double blinded
Blinding description
Randomization was assigned to a random assignment list by a research team member as the only non-blind person. Other members of the research team (including team leader and study coordinator) as well as all participants participated in the random allocation of blind groups and remained blind until the end of the study.In fact, in this study, patients were blinded to use of placebo or supplementation. Also, all of the study subjects were blind except for one group.
Placebo
Used
Assignment
Factorial
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
ethics Committee of Urmia University of Medical Sciences
Street address
Nutrition Department, Faculty of Medicine, College of Medicine, Urmia University of Medical Science, 11th km of Nazloo Road, Urmia
City
Urmia
Province
West Azarbaijan
Postal code
5714783734
Approval date
2016-09-09, 1395/06/19
Ethics committee reference number
IR.UMSU.REC.1395.370
Health conditions studied
1
Description of health condition studied
Type 2 diabetes
ICD-10 code
E10, E11,
ICD-10 code description
Diabetes mellitus
Primary outcomes
1
Description
Total cholesterol
Timepoint
Before intervention and two months after intervention
Method of measurement
Enzymatic method, mg / dl
2
Description
TAC
Timepoint
Before intervention and two months after intervention
Method of measurement
Colorimetric
3
Description
hs-crp
Timepoint
Before intervention and two months after intervention
Method of measurement
Eliza-mg/dl
4
Description
HDL
Timepoint
Before intervention and two months after intervention
Method of measurement
Enzymatic method, mg / dl
5
Description
Tri glyceride
Timepoint
Before intervention and two months after intervention
Method of measurement
Enzymatic method, mg / dl
6
Description
LDL
Timepoint
Before intervention and two months after intervention
Method of measurement
Enzymatic method, mg / dl
Secondary outcomes
empty
Intervention groups
1
Description
Group A = Intervention group with omega-3 doses of 1000 mg with lunch
Category
Treatment - Drugs
2
Description
Group C = Omega 3 group with zinc
Category
Treatment - Drugs
3
Description
Group A = Intervention group with zinc dose of 30 mg in the evening meal
Category
Treatment - Drugs
4
Description
Group D = Receptor of Starch Placebo
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Khomeini Hospital of Urmia
Full name of responsible person
Dr. Peyvand Mohammadi Endocrinologist
Street address
Floor 2, Imam Khomeini Hospital professional clinic (1), Ershad Ave urmia West Azarbgijan
City
Urmia
Province
West Azarbaijan
Postal code
5715799313
Phone
+98 38 3333 3792
Fax
+98 44 3278 0801
Email
mehdikhakian1371@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Urmia University of Medical Sciences
Full name of responsible person
Mehdikhakian
Street address
Nutrition counseling office and diet therapy,Imam Khomeini Hospital, Ershad Ave Urmia West Azarbgijan Iran, Islamic Republic Of
City
Urmia
Province
West Azarbaijan
Postal code
5715799313
Phone
+98 44 3223 6151
Fax
+98 44 3278 0801
Email
mehdikhakian1371@yahoo.com
Grant name
-
Grant code / Reference number
-
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Urmia 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
Urmia University of Medical Sciences
Full name of responsible person
Majid Monafi
Position
Master of Science in Nutrition Sciences
Latest degree
Master
Other areas of specialty/work
Nutrition
Street address
Urmia University of Medical Sciences
City
Urmia
Province
West Azarbaijan
Postal code
5714783734
Phone
+98 44433659218
Fax
Email
MAJIDMANAFI@YAHOO.COM
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Urmia University of Medical Sciences
Full name of responsible person
Majid Monafi
Position
Masters
Latest degree
Master
Other areas of specialty/work
Nutrition
Street address
Urmia University of Medical Sciences
City
Urmia
Province
West Azarbaijan
Postal code
5714783734
Phone
+98 44433659218
Fax
Email
MAJIDMANAFI@YAHOO.COM
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Urmia University of Medical Sciences
Full name of responsible person
Majid Manafi
Position
Masters of Nutrition
Latest degree
Master
Other areas of specialty/work
Nutrition
Street address
Nutrition Department, Faculty of Medicine, College of Medicine, Urmia University of Medical Science, 11th km of Nazloo Road Urmia West Azarbijan Iran, Islamic Republic Of
City
Urmia
Province
West Azarbaijan
Postal code
5715799313
Phone
+98 32770698
Fax
Email
manafi.m@umsu.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
Unwillingness to publish individual data
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
In this study, only the original outcome can be published
When the data will become available and for how long
Start the access period one year after the print results
To whom data/document is available
People working in academic institutions
Under which criteria data/document could be used
is not allowed type of analysis on data
From where data/document is obtainable
Phone number 09132801511 and email mehdikhakian1371@yahoo.com
What processes are involved for a request to access data/document
Applicants will be able to access data after two months of requesting data, with full details of their profile.