Protocol summary

Summary
Objective: 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 and inflammatory factors in in patients with Parkinson's. Study design: Parallel double-blind (both patients and researchers) randomized controlled clinical trial. Random assignment will be done by the use of computer-generated random numbers. Inclusion criteria: in Patients with Parkinson's and aged 50 to 90 years will be included in this study. Exclusion criteria: Unwillingness to cooperate will be excluded in the study. Population and sample size: 40 patients with Parkinson's of eligible and referred to Naghavi Clinic affiliated to Kashan University of Medical Sciences, Kashan, Iran in the study will be selected. Intervention: 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. Fasting blood samples will be taken at baseline and 12 weeks after the intervention. At the beginning and end of the intervention: 12 weeks. Outcomes: Levels of gene expression related with glycemic control and inflammatory factors will be quantified at study baseline and end-of-trial.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2017061234497N1
Registration date: 2017-06-20, 1396/03/30
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2017-06-20, 1396/03/30
Registrant information
Name
Omid Reza Tamtaji
Name of organization / entity
Kashan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 5562 1157
Email address
tamtaji-or@kaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Kashan University of Medical Sciences
Expected recruitment start date
2017-04-20, 1396/01/31
Expected recruitment end date
2017-04-30, 1396/02/10
Actual recruitment start date
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Actual recruitment end date
empty
Trial completion date
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Scientific title
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 and inflammatory factors in patients with Parkinson's
Public title
Effect of omega-3 plus vitamin E supplementation in treatment of patients with Parkinson's
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Patients with Parkinson's; aged 50 to 90 years. Exclusion criteria: Unwillingness to cooperate.
Age
From 50 years old to 90 years old
Gender
Both
Phase
2
Groups that have been masked
None
Sample size
Target sample size: 40
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

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Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Kashan University of Medical Sciences
Street address
Ghotbe Ravandi Boulevard, Kashan
City
Kashan
Country
Iran (Islamic Republic of)
Postal code
Iran, Islamic Republ
Approval date
2017-04-19, 1396/01/30
Ethics committee reference number
IR.Kaums.REC.1396.3

Health conditions studied

1

Description of health condition studied
Parkinson disease
ICD-10 code
G20
ICD-10 code description
Parkinson disease

Primary outcomes

1

Description
Tumor necrosis factor alpha
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
PCR

Secondary outcomes

1

Description
Interleukin 6
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
PCR

Intervention groups

1

Description
Control group: Placebo, daily, for 12 weeks orally.
Category
Treatment - Drugs

2

Description
Intervention group: Omega-3 fatty acid plus vitamin E capsule, 1800 mg omega-3 fatty acid plus 200 IU vitamin E, daily for 12 weeks orally.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Naghavi Clinic
Full name of responsible person
Zatollah Asemi
Street address
Shahid Rajaee Avenue, Kashan
City
Kasham
Country
Iran (Islamic Republic of)

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research, Kashan University of Medical Sciences
Full name of responsible person
Gholamali Hamidi
Street address
Ghotbe Ravandi Boulevard, Kashan
City
Kashan
Country
Iran (Islamic Republic of)
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Kashan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
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Person responsible for general inquiries

Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Zatollah Asemi
Position
PhD of Nutrition
Other areas of specialty/work
Street address
Ghotbe Ravandi Boulevard, Kashan
City
Kashan
Country
Iran (Islamic Republic of)
Postal code
Phone
+98 31 5546 3378
Fax
Email
asemi_z@kaums.ac.ir; asemi_r@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Zatollah Asemi
Position
PhD of Nutrition
Other areas of specialty/work
Street address
Ghotbe Ravandi Boulevard, Kashan
City
Kashan
Country
Iran (Islamic Republic of)
Postal code
Phone
+98 31 5546 3378
Fax
Email
asemi_z@kaums.ac.ir; asemi_r@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Omid Reza Tamtaji
Position
MSc student of medical physiology
Other areas of specialty/work
Street address
Ghotbe Ravandi Boulevard, Kashan
City
Kashan
Country
Iran (Islamic Republic of)
Postal code
Phone
+98 31 5562 1157
Fax
Email
tamtaji_or@yahoo.comtamtaji-or@kaums.ac.ir
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
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Study Protocol
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Statistical Analysis Plan
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Informed Consent Form
empty
Clinical Study Report
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Analytic Code
empty
Data Dictionary
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