Protocol summary
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Study aim
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The aim of this study is to determine the effects of omega-3 supplementation on disease severity and metabolic profiles in patients with Parkinson's.
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Design
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Parallel double-blind (both patients and researchers) randomized controlled clinical trial.
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Settings and conduct
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patients with Parkinson's of eligible and referred to Shahid Beheshti Clinic affiliated to Kashan University of Medical Sciences, Kashan, Iran in the study will be selected.
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Participants/Inclusion and exclusion criteria
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Patients with Parkinson's and aged 50 to 80 years will be included in this study. Exclusion criteria are patients who were already taking omega-3 and/or vitamin E, had depression and had severe psychosis.
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Intervention groups
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Patients will be assigned to receive either omega-3 plus vitamin E supplements (intervention group: n=30) and placebo (control group: n=30).
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Main outcome variables
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Fasting blood glucose, insulin resistance, insulin, inflammatory factors, oxidative stress and disease severity
General information
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Reason for update
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT201604035623N73
Registration date:
2016-04-07, 1395/01/19
Registration timing:
registered_while_recruiting
Last update:
2019-09-15, 1398/06/24
Update count:
1
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Registration date
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2016-04-07, 1395/01/19
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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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Kashan University of Medical Sciences
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Expected recruitment start date
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2016-03-10, 1394/12/20
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Expected recruitment end date
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2016-04-10, 1395/01/22
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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Clinical trial of the effect of omega-3 plus vitamin E supplementation compared with the placebo on disease severity and metabolic profiles in patients with Parkinson's
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Public title
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Effect of supplementation in treatment of patients with Parkinson's
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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Inclusion criteria:
Patients with Parkinson's
Aged 50 to 80 years
Exclusion criteria:
Patients who were already taking omega-3 and/or vitamin E
Patients who had depression
Patients who had severe psychosis.
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Age
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From 50 years old to 80 years old
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Gender
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Both
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Phase
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2
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Groups that have been masked
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- Participant
- Investigator
- Outcome assessor
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Sample size
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Target sample size:
60
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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At study baseline and after balanced block randomization, subjects will be randomly divided into two groups to take either omega-3 plus vitamin E supplementation (n = 30) or placebo (n = 30). Randomization will be done by the use of computer-generated random numbers.
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Blinding (investigator's opinion)
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Double blinded
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Blinding description
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Randomization and allocation will be concealed from the researchers and participants until the final analyses are completed. Another person at the Shahid Beheshti Clinic, who is not involved in the trial and not aware of random sequences, will be assigned the participants to the numbered bottles of capsules.
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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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2016-03-09, 1394/12/19
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Ethics committee reference number
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IR.Kaums.REC.1394.141
Health conditions studied
1
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Description of health condition studied
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Parkinson's disease
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ICD-10 code
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G31
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ICD-10 code description
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Other degenerative diseases of nervous system, not elsewhere classified
Primary outcomes
1
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Description
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High-sensitivity C-reactive protein
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Timepoint
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At the beginning of the study and after 12 weeks of intervention
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Method of measurement
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Elisa kit
2
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Description
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Unified Parkinson's Disease Rating Stage (UPDRS)
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Timepoint
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At the beginning of the study and after 12 weeks of intervention
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Method of measurement
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Physical Examination by Neurologist
Secondary outcomes
1
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Description
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Triglycerides
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Timepoint
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At the beginning of the study and after 12 weeks of intervention
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Method of measurement
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Enzymatic kit
2
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Description
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HDL-cholesterol
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Timepoint
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At the beginning of the study and after 12 weeks of intervention
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Method of measurement
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Enzymatic kit
3
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Description
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Total cholesterol
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Timepoint
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At the beginning of the study and after 12 weeks of intervention
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Method of measurement
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Enzymatic kit
4
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Description
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Insulin
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Timepoint
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At the beginning of the study and after 12 weeks of intervention
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Method of measurement
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Elisa kit
5
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Description
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Fasting plasma glucose
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Timepoint
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At the beginning of the study and after 12 weeks of intervention
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Method of measurement
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Enzymatic kit
6
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Description
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LDL-cholesterol
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Timepoint
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At the beginning of the study and after 12 weeks of intervention
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Method of measurement
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Enzymatic kit
7
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Description
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Insulin resistance
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Timepoint
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At the beginning of the study and after 12 weeks of intervention
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Method of measurement
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Calculation using HOMA formula
Intervention groups
1
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Description
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Intervention group: Omega-3 fatty acid plus vitamin E capsule, 1000 mg omega-3 fatty acid plus 400 IU vitamin E, daily for 12 weeks orally.
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Category
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Treatment - Drugs
2
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Description
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Control group: Placebo, daily, for 12 weeks orally.
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Category
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Treatment - Drugs
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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Kashan 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