Protocol summary
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Study aim
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Determining the effect of omega-3 supplementation on serum interleukin 6 level, tumor necrosis factor alpha and depressive status in bipolar patients
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Design
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Clinical trial with control group, with parallel groups, double-blind, randomized, phase 3 on 60 patients.
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Settings and conduct
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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.
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Participants/Inclusion and exclusion criteria
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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.
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Intervention groups
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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 .
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Main outcome variables
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1) Means of interleukin 6 and tumor necrosis factor-alpha
2) Depression score in the Hamilton questionnaire
General information
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Reason for update
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Termination of the trial
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20211220053469N1
Registration date:
2021-12-29, 1400/10/08
Registration timing:
prospective
Last update:
2022-04-17, 1401/01/28
Update count:
2
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Registration date
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2021-12-29, 1400/10/08
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2022-01-27, 1400/11/07
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Expected recruitment end date
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2022-04-13, 1401/01/24
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Actual recruitment start date
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2022-01-09, 1400/10/19
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Actual recruitment end date
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2022-01-12, 1400/10/22
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Trial completion date
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2022-03-14, 1400/12/23
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Scientific title
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The assessment of the effect of omega-3 supplementation on serum interleukin-6, alpha tumor necrosis factor and depression status in bipolar patients
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Public title
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The assessment of the effect of omega-3 supplementation on serum interleukin-6, alpha tumor necrosis factor and depression status in bipolar patients
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Purpose
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Supportive
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Inclusion/Exclusion criteria
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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
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Age
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From 16 years old to 50 years old
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Gender
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Both
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Phase
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3
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Groups that have been masked
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- Care provider
- Outcome assessor
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Sample size
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Target sample size:
60
Actual sample size reached:
60
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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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)
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Blinding (investigator's opinion)
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Double blinded
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Blinding description
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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.
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Placebo
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Used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2021-12-25, 1400/10/04
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Ethics committee reference number
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IR.ZAUMS.REC.1400.319
Health conditions studied
1
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Description of health condition studied
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Bipolar disorder
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ICD-10 code
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F31.3
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ICD-10 code description
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Bipolar disorder, current episode depressed, mild or moderate severity
Primary outcomes
1
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Description
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Mean of interleukin 6
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Timepoint
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At the beginning of the study (before the intervention) and 60 days after the start of omega-3 supplementation
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Method of measurement
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Commercial Kit / ELISA
2
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Description
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Mean of alpha tumor necrosis factor
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Timepoint
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At the beginning of the study (before the intervention) and 60 days after the start of omega-3 supplementation
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Method of measurement
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Commercial Kit / ELISA
3
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Description
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Depression score on the Hamilton questionnaire
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Timepoint
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At the beginning of the study (before the intervention) and 60 days after the start of omega-3 supplementation
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Method of measurement
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Hamilton questionnaire
Intervention groups
1
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Description
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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.
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Category
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Rehabilitation
2
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Description
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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.
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Category
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Rehabilitation
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Zahedan University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Undecided - It is not yet known if there will be a plan to make this available
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Study Protocol
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Undecided - It is not yet known if there will be a plan to make this available
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Statistical Analysis Plan
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Undecided - It is not yet known if there will be a plan to make this available
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Informed Consent Form
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Undecided - It is not yet known if there will be a plan to make this available
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Clinical Study Report
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Undecided - It is not yet known if there will be a plan to make this available
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Analytic Code
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Undecided - It is not yet known if there will be a plan to make this available
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Data Dictionary
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Undecided - It is not yet known if there will be a plan to make this available