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 plus vitamin E supplementation on levels of gene expression related with glycemic control, lipid and inflammatory factors in in patients with Parkinson's.
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Design
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This study is a parallel double-blind (both patients and researchers) randomized controlled clinical trial.
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Settings and conduct
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40 patients with Parkinson's of eligible and referred to Shahid Beheshti Clinic , Kashan, Iran in the study will be selected.
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Participants/Inclusion and exclusion criteria
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Inclusion criteria is PD patients aged 50–80 years old. Exclusion criteria are subjects who were already taking omega-3 and/or vitamin E, taking DDP4 inhibitors, statins and anti-inflammatory drugs, have depression and have severe psychosis.
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Intervention groups
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Patients will be assigned to receive either omega-3 plus vitamin E (n=20) or placebo (n=20). Omega-3 plus vitamin E and placebos capsules are similar in shape and size.
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Main outcome variables
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Fasting blood samples will be taken at baseline and 12 weeks after the intervention. Levels of gene expression related with glycemic control, lipid and inflammatory factors will be quantified at study baseline and end-of-trial.
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:
IRCT2017061234497N1
Registration date:
2017-06-20, 1396/03/30
Registration timing:
retrospective
Last update:
2019-09-15, 1398/06/24
Update count:
1
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Registration date
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2017-06-20, 1396/03/30
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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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2017-04-20, 1396/01/31
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Expected recruitment end date
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2017-04-30, 1396/02/10
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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 levels of gene expression related with glycemic control, lipid and inflammatory factors in patients with Parkinson's
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Public title
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Effect of omega-3 plus vitamin E 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:
Subjects who were already taking omega-3 and/or vitamin E
Subjects who were taking DDP4 inhibitors, statins and anti-inflammatory drugs
Subjects who had depression and 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:
40
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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, after balance randomization, subjects will be randomly divided into two groups to take either vitamin E plus omega-3 supplements (n = 20) or placebo (n = 20). 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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2017-04-19, 1396/01/30
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Ethics committee reference number
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IR.Kaums.REC.1396.3
Health conditions studied
1
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Description of health condition studied
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Parkinson disease
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ICD-10 code
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G20
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ICD-10 code description
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Parkinson disease
Primary outcomes
1
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Description
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Tumor necrosis factor alpha
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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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PCR
2
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Description
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Interleukin-1
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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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PCR
3
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Description
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Interleukin-8
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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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PCR
Secondary outcomes
1
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Description
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Peroxisome proliferator–activated receptor γ (PPARγ)
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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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PCR
2
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Description
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Low Density Lipoprotein Receptor (LDLR)
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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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PCR
Intervention groups
1
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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
2
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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
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