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Protocol summary
Intervention group:30 patients with bipolar disorder who received omega-3 supplement.
Control group:30 patients with bipolar disorder receiving a placebo containing olive oil.
Intervention group:30 patients with bipolar disorder who received omega-3 supplement.
Control group:30 patients with bipolar disorder receiving a placebo containing edible paraffin oil .
Intervention group:30 patients with bipolar disorder who received omega-3 supplement. Control group:30 patients with bipolar disorder receiving a placebo containing oliveedible paraffin oil.
گروه مداخله : 30 بیمار مبتلا به دوقطبی که مکمل امگا3 دریافت می کنند.
گروه کنترل: 30 بیمار مبتلا به دوقطبی که پلاسبو حاوی روغن زیتون دریافت می کنند.
گروه مداخله : 30 بیمار مبتلا به دوقطبی که مکمل امگا3 دریافت می کنند.
گروه کنترل: 30 بیمار مبتلا به دوقطبی که پلاسبو حاوی روغن پارافین خوراکی دریافت می کنند.
گروه مداخله : 30 بیمار مبتلا به دوقطبی که مکمل امگا3 دریافت می کنند. گروه کنترل: 30 بیمار مبتلا به دوقطبی که پلاسبو حاوی روغن زیتونپارافین خوراکی دریافت می کنند.
General information
empty
Incorrect registration of the type of placebo used:
In the present study, the type of placebo used was oral paraffin oil, which was incorrectly registered as olive oil.
Incorrect registration of the type of placebo used: In the present study, the type of placebo used was oral paraffin oil, which was incorrectly registered as olive oil.
empty
ثبت اشتباه نوع پلاسبو مصرفی:
در مطالعه حاضر نوع پلاسبو مصرفی روغن پارافین خوراکی بوده است که به اشتباه روغن زیتون ثبت شده است.
ثبت اشتباه نوع پلاسبو مصرفی: در مطالعه حاضر نوع پلاسبو مصرفی روغن پارافین خوراکی بوده است که به اشتباه روغن زیتون ثبت شده است.
Intervention groups
#1
Control group: 30 patients with bipolar disorder, in addition to their usual treatment, will receive 2 placebo capsules containing olive oil (made by Barij Pharmaceutical Company) , each capsule containing 1 gram of olive oil, for 8 weeks, which is recommended to be taken with lunch and dinner.
Control group: 30 patients with bipolar disorder, in addition to their usual treatment, will receive 2 placebo capsules containing edible paraffin oil (made by Barij Pharmaceutical Company) , each capsule containing 1 gram of edible paraffin oil , for 8 weeks, which is recommended to be taken with lunch and dinner.
Control group: 30 patients with bipolar disorder, in addition to their usual treatment, will receive 2 placebo capsules containing oliveedible paraffin oil (made by Barij Pharmaceutical Company) , each capsule containing 1 gram of oliveedible paraffin oil, for 8 weeks, which is recommended to be taken with lunch and dinner.
گروه کنترل: 30 بیمار مبتلا به اختلال دو قطبی علاوه بر درمان معمول خود،روزانه 2 کپسول دارونما حاوی روغن زیتون (ساخت شرکت داروسازی باریج) که هر کپسول محتوی1 گرم روغن زیتون است به مدت 8 هفته دریافت خواهند کردکه توصیه می شود همراه با ناهار و شام آن را مصرف نماید.
گروه کنترل: 30 بیمار مبتلا به اختلال دو قطبی علاوه بر درمان معمول خود،روزانه 2 کپسول دارونما حاوی روغن پارافین خوراکی (ساخت شرکت داروسازی باریج) که هر کپسول محتوی1 گرم روغن پارافین خوراکی است به مدت 8 هفته دریافت خواهند کردکه توصیه می شود همراه با ناهار و شام آن را مصرف نماید.
گروه کنترل: 30 بیمار مبتلا به اختلال دو قطبی علاوه بر درمان معمول خود،روزانه 2 کپسول دارونما حاوی روغن زیتونپارافین خوراکی (ساخت شرکت داروسازی باریج) که هر کپسول محتوی1 گرم روغن زیتونپارافین خوراکی است به مدت 8 هفته دریافت خواهند کردکه توصیه می شود همراه با ناهار و شام آن را مصرف نماید.
Recruitment centers
#1
Name of recruitment center - English: Baharan hospital
Name of recruitment center - Persian: بیمارستان بهاران
Full name of responsible person - English: Azizullah Mujahid
Full name of responsible person - Persian: عـزیـزالله مجــاهد
Street address - English: Imam Khomeini St.,in front of the Grain Department
Street address - Persian: خیابان امام خمینی (ره) ، روبری اداره غله
City - English: Zahedan
City - Persian: زاهدان
Province: Sistan-va-Balouchestan
Country: Iran (Islamic Republic of)
Postal code: 9813913777
Phone: +98 54 3351 3777
Fax:
Email: baharanhospital@zaums.ac.ir
Web page address:
Name of recruitment center - English: Baharan hospital
Name of recruitment center - Persian: بیمارستان بهاران
Full name of responsible person - English: Azizullah Mujahed
Full name of responsible person - Persian: عـزیـزالله مجــاهد
Street address - English: Imam Khomeini St.,in front of the Grain Department
Street address - Persian: خیابان امام خمینی (ره) ، روبری اداره غله
City - English: Zahedan
City - Persian: زاهدان
Province: Sistan-va-Balouchestan
Country: Iran (Islamic Republic of)
Postal code: 9813913777
Phone: +98 54 3351 3777
Fax:
Email: baharanhospital@zaums.ac.ir
Web page address:
Name of recruitment center - English: Baharan hospital Name of recruitment center - Persian: بیمارستان بهاران Full name of responsible person - English: Azizullah MujahidMujahed Full name of responsible person - Persian: عـزیـزالله مجــاهد Street address - English: Imam Khomeini St.,in front of the Grain Department Street address - Persian: خیابان امام خمینی (ره) ، روبری اداره غله City - English: Zahedan City - Persian: زاهدان Province: Sistan-va-Balouchestan Country: Iran (Islamic Republic of) Postal code: 9813913777 Phone: +98 54 3351 3777 Fax: Email: baharanhospital@zaums.ac.ir Web page address:
Protocol summary
Study aim
Determining the effect of omega-3 supplementation on serum interleukin 6 level, tumor necrosis factor alpha and depressive status in bipolar patients
Design
Clinical trial with control group, with parallel groups, double-blind, randomized, phase 3 on 60 patients.
Settings and conduct
The study will be conducted on 60 patients with bipolar disorder in depressed phase who have been ill for at least 6 months. Eligible individuals will be randomly divided into two groups. In addition to their usual treatment, one group will receive 2 gr omega-3 supplement for 8 weeks and the other group or control group will receive their usual placebo for 8 weeks. Double blinding method is used. A person who is responsible for giving supplements and the intervention and the technician responsible for recording the consequences will not be aware the study.
Participants/Inclusion and exclusion criteria
Inclusion criteria
1)The involvement with bipolar disease
2)16-50 years of age
3)Patients with minimum six months after onset of disease.
4)Informed and freely consent for participation in study.
5)The lack of receiving omega-3 supplement several months before of participation in the study.
6)The lack of programmed surgery in three months future and consumption of drugs interfering with omega-3.
7)The lack of high blood pressure and consumption of alcohol and drugs.
Exclusion criteria
1)Change in drug dose and type.
2)Reactivity against omega-3
3)The consumption of lesser than 80% supplement.
4)Having inflammation and infectious diseases.
5)Withdrawal of the study for any reason.
Intervention groups
Intervention group:30 patients with bipolar disorder who received omega-3 supplement.
Control group:30 patients with bipolar disorder receiving a placebo containing edible paraffin oil .
Main outcome variables
1) Means of interleukin 6 and tumor necrosis factor-alpha
2) Depression score in the Hamilton questionnaire
General information
Reason for update
Incorrect registration of the type of placebo used:
In the present study, the type of placebo used was oral paraffin oil, which was incorrectly registered as olive oil.
Acronym
IRCT registration information
IRCT registration number:IRCT20211220053469N1
Registration date:2021-12-29, 1400/10/08
Registration timing:prospective
Last update:2022-03-09, 1400/12/18
Update count:2
Registration date
2021-12-29, 1400/10/08
Registrant information
Name
Hadi Eslahi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 54 3348 4862
Email address
hadi_eslahi2015@zaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-01-27, 1400/11/07
Expected recruitment end date
2022-04-13, 1401/01/24
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The assessment of the effect of omega-3 supplementation on serum interleukin-6, alpha tumor necrosis factor and depression status in bipolar patients
Public title
The assessment of the effect of omega-3 supplementation on serum interleukin-6, alpha tumor necrosis factor and depression status in bipolar patients
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
The involvement with bipolar disease
Patients with minimum six months after onset of disease
Informed and freely consent for participation in the design by patient and family members.
The lack of receiving omega-3 supplement several months before of participation in the study
The lack of programmed surgery in three months future
The lack of consumption of drugs interfering with omega-3 such as anticoagulant drugs
The lack of high blood pressure
The lack of alcohol and drugs
Exclusion criteria:
The change in drug dose and type
Sensitive reaction against omega-3
The consumption of lesser than 80% supplement
The involvement with inflammatory and infectious diseases
Withdrawal of the study for any reason
Age
From 16 years old to 50 years old
Gender
Both
Phase
3
Groups that have been masked
Care provider
Outcome assessor
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization of patients is conducted based on permuted block stratified randomization. The patients are classed based on age and gender. The patients are randomly selected based on quadruplet blocks (two groups A & B and two replications for each group). The blocks are designed by help of R software (version of 4.02)
Blinding (investigator's opinion)
Double blinded
Blinding description
Double blinding is used in the current study, so that person giving supplements and intervention, technician responsible for registration will not be informed study details.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Zahedan University of Medical Sciences
Street address
Islamic Republic Boulevard, 18 meters Golha Street, Golha 3, Milan 2, right, second side, left
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816993353
Approval date
2021-12-25, 1400/10/04
Ethics committee reference number
IR.ZAUMS.REC.1400.319
Health conditions studied
1
Description of health condition studied
Bipolar disorder
ICD-10 code
F31.3
ICD-10 code description
Bipolar disorder, current episode depressed, mild or moderate severity
Primary outcomes
1
Description
Mean of interleukin 6
Timepoint
At the beginning of the study (before the intervention) and 60 days after the start of omega-3 supplementation
Method of measurement
Commercial Kit / ELISA
2
Description
Mean of alpha tumor necrosis factor
Timepoint
At the beginning of the study (before the intervention) and 60 days after the start of omega-3 supplementation
Method of measurement
Commercial Kit / ELISA
3
Description
Depression score on the Hamilton questionnaire
Timepoint
At the beginning of the study (before the intervention) and 60 days after the start of omega-3 supplementation
Method of measurement
Hamilton questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: 30 patients with bipolar disorder, in addition to their usual treatment, will receive 2 omega 3 capsules daily (made by Barij Pharmaceutical Company), each capsule containing 1 gram of omega 3, for 8 weeks, which is recommended to be taken with lunch and dinner.
Category
Rehabilitation
2
Description
Control group: 30 patients with bipolar disorder, in addition to their usual treatment, will receive 2 placebo capsules containing edible paraffin oil (made by Barij Pharmaceutical Company) , each capsule containing 1 gram of edible paraffin oil , for 8 weeks, which is recommended to be taken with lunch and dinner.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Baharan hospital
Full name of responsible person
Azizullah Mujahed
Street address
Imam Khomeini St.,in front of the Grain Department
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9813913777
Phone
+98 54 3351 3777
Email
baharanhospital@zaums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Noor Mohammad Bakhshani
Street address
Persian Gulf Boulevard., Dr. Hesabi Square., Campus of the University of Medical Sciences., Headquarters Building., Second Floor
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816743463
Phone
+98 54 3337 2116
Email
zaums.research@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Zahedan 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
Zahedan University of Medical Sciences
Full name of responsible person
Hadi Eslahi
Position
Masters student
Latest degree
Bachelor
Other areas of specialty/work
Nutrition
Street address
Islamic Republic Boulevard., 18 meters Golha Street., Golha 3., Milan 2., right., second side., left
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816993353
Phone
+98 54 3348 4862
Email
hadi_eslahi2015@zaums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Hadi Eslahi
Position
Masters student
Latest degree
Bachelor
Other areas of specialty/work
Nutrition
Street address
Islamic Republic Boulevard., 18 meters Golha Street., Golha 3., Milan 2., right., second side., left
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816993353
Phone
+98 54 3348 4862
Email
hadi_eslahi2015@zaums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Hadi Eslahi
Position
Masters student
Latest degree
Bachelor
Other areas of specialty/work
Nutrition
Street address
Islamic Republic Boulevard., 18 meters Golha Street., Golha 3., Milan 2., right., second side., left
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816993353
Phone
+98 54 3348 4862
Email
hadi_eslahi2015@zaums.ac.ir
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