The effect of omega-3 and zinc supplements on liver and kidney parameters in type 2 diabetic patients
Design
This study was performed as a randomized, parallel controlled clinical trial on 80 patients with type 2 diabetes.
Settings and conduct
This study was performed as a randomized, parallel controlled clinical trial on 80 patients with type 2 diabetes. In this study, while receiving written informed consent from patients, participants were blinded to receiving drugs and placebo.
Participants/Inclusion and exclusion criteria
Criteria for entering the study: type 2 diabetes and age range older than 18 years Non-inclusion criteria: insulin infusion. kidney disease. Severe physical activity during the intervention
Intervention groups
Patients were divided into three groups of intervention and one control group.
The intervention group with Omega-3,The intervention group with Zinc, the intervention group with omega-3 and zinc and placebo group
Main outcome variables
Indicators of liver (ALT, AST, ALP, GGT and albumin) and renal indices (creatinine, uric acid and blood urea)
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180201038585N1
Registration date:2018-03-10, 1396/12/19
Registration timing:retrospective
Last update:2018-03-10, 1396/12/19
Update count:0
Registration date
2018-03-10, 1396/12/19
Registrant information
Name
Karim Parastouei
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8248 3516
Email address
parastouei@bmsu.ac.ir
Recruitment status
Recruitment complete
Funding source
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 supplementation of omega-3 and zinc on liver and kidney parameters in type 2 diabetic patients
Public title
The effect of supplementation of omega-3 and zinc on the treatment of type 2 diabetes
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Adults with Type 2 Diabetes
Exclusion criteria:
Insulin injection
Pregnancy and lactation
Pancreatic cancer
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 groups 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).
Blinding (investigator's opinion)
Double blinded
Blinding description
Intervention and randomization through a random allocation list was made by a member of the research team as the only non-blind person to be assigned. Other team members (including team leader and study coordinator), as well as all participants, were randomly allocated to blind groups and remained blind until the end of the study.
Placebo
Used
Assignment
Factorial
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
The Ethics Committee of the University of Medical Sciences
Street address
Mollasadra street, Vanak Square, Baqiyatallah University of Medical Sciences
City
Tehran
Province
Tehran
Postal code
1435916471
Approval date
2017-05-02, 1396/02/12
Ethics committee reference number
IR.BMSU.REC.1396.6992
Health conditions studied
1
Description of health condition studied
Type 2 diabetes
ICD-10 code
E11
ICD-10 code description
Diabetes mellitus
Primary outcomes
1
Description
Alanine aminotransferase
Timepoint
At weeks 0, 8
Method of measurement
Enzymatic method-IU/Lit
2
Description
Aspartate aminotransferase
Timepoint
At weeks 0, 8
Method of measurement
Enzymatic method-IU/Lit
3
Description
Gamma glutamyl transpeptidase
Timepoint
At weeks 0, 8
Method of measurement
Enzymatic method-IU/Lit
4
Description
Alkaline phosphatase
Timepoint
At weeks 0, 8
Method of measurement
Enzymatic method-IU/Lit
5
Description
Creatinine
Timepoint
At weeks 0, 8
Method of measurement
Enzymatic method, mg/dl
6
Description
Uric acid
Timepoint
At weeks 0, 8
Method of measurement
Enzymatic method, mg/dl
7
Description
Urea
Timepoint
At weeks 0, 8
Method of measurement
Enzymatic method, mg/dl
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Group A = Intervention with omega-3 at a dose of 1000 mg daily one number capsule for 8 weeks - Dana Pharmaceutical Company
Category
Treatment - Drugs
2
Description
Intervention group: Group B: Intervention with zinc at a dose of 30 mg daily One number tablet for 8 weeks - Dine Pharmaceutical Company
Category
Treatment - Drugs
3
Description
Intervention group: Group C: Intervention with omega-3 at a dose of 1000 mg plus zinc at a dose of 30 mg daily for 8 weeks
Category
Treatment - Drugs
4
Description
Control group: Group D:In this study, individuals in the control group received one capsule 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
Street address
Floor 2, Imam Khomeini Hospital professional clinic (1), Ershad Ave
City
Urmia
Province
West Azarbaijan
Postal code
5715799313
Phone
+98 44 3223 7601
Fax
+98 44 3278 0801
Email
mehdikhakian1371@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Bagheiat-allah University of Medical Sciences
Full name of responsible person
Karim Parastouei
Street address
Mollasadra street, Vanak Square, Tehran
City
Tehran
Province
Tehran
Postal code
1435916471
Phone
+98 21 8804 0060
Email
parastouei@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Baqiyatallah 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
Bagheiat-allah University of Medical Sciences
Full name of responsible person
Karim Parastouei
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Mollasadra street, Vanak Square, Baqiyatallah University of Medical Sciences
City
Tehran
Province
Tehran
Postal code
1435916471
Phone
+98 21 8804 0060
Fax
+98 21 8804 0060
Email
parastouei@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Bagheiat-allah University of Medical Sciences
Full name of responsible person
Karim Parastouei
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Mollasadra street, Vanak Square, Baqiyatallah University of Medical Sciences
City
Tehran
Province
Tehran
Postal code
1435916471
Phone
+98 21 8804 0060
Fax
+98 21 8804 0060
Email
parastouei@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Bagheiat-allah University of Medical Sciences
Full name of responsible person
Karim Parastuie
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Mullasadra Street, Vanak Square, Baqiyatollah University of Medical Sciences
City
Tehran
Province
Tehran
Postal code
1435916471
Phone
+98 21 8804 0060
Fax
+98 21 8804 0060
Email
parastouei@gmail.com
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