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The combined effects of omega3 fatty acids and curcumin supplementation on Oxidative Stress in migraine patients

Protocol summary

Summary
Present study aimed to examination the effects of supplementation of omega-3, nano-curcumin and combination of them on oxidative stress in patients with migraine. Inclusion criteria included age 20-50, patients with episodic migraine, any other disorders, avoidance of consumption of supplements or vitamins and any use of special diet, supplements or activity. Exclusion criteria comprise of allergic reaction to omega-3 or nano-curcumin compounds, unwilling of patient to cooperation, pregnancy, any sever changes in diet, usual lifestyle, taking drugs or dosage and any inflammatory disorders that patients have to take anti-inflammatory drugs more than 2 weeks. Eighty migraine patients enrolled in this randomized double-blind clinical trial study and allocated to 4 groups based on stratified randomization method including: 1) receiving combination of omega-3 and nano-curcumin 2) receiving omega-3 and placebo of nano-curcumin 3) receiving nano-curcumin and placebo of omega-3 and 4) receiving omega-3 placebo and nano-curcumin placebo. Patients in omega-3 group take 2 capsules of 1250 mg twice/day, in nano-curcumin group the patients take one capsule of 80 mg nao-curcumin once/day and the combined group take both of them. Control group also take placebo. At the beginning and the end of the study, serum levels of malondialdehyde, glutathione peroxidase and superoxide dismutase will be evaluated by ELISA method.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2015073123434N1
Registration date: 2017-07-23, 1396/05/01
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2017-07-23, 1396/05/01
Registrant information
Name
Mina Abdolahi
Name of organization / entity
School of Nutritional Sciences and Dietetics, Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8895 5975
Email address
m-abdolahi@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran University of Medical Sciences
Expected recruitment start date
2013-05-22, 1392/03/01
Expected recruitment end date
2016-08-22, 1395/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
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Scientific title
The combined effects of omega3 fatty acids and curcumin supplementation on Oxidative Stress in migraine patients
Public title
The effects of Omega-3 and nano-curcumin on migraine disorder
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: age 20-50; patients with episodic migraine; any other disorders; avoidance of consumption of supplements or vitamins at least 4-6 weeks before intervention and during study; any use of special diet, supplements of activity. Exclusion criteria: Allergic reaction to omega-3 or nano-curcumin compounds; Cancel of patient from cooperation; pregnancy; any sever changes in diet, usual lifestyle or taking drugs; any inflammatory disorders that have to take anti-inflammatory drugs (more than 2 weeks).
Age
From 20 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 80
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Factorial
Other design features

Secondary Ids

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Ethics committees

1

Ethics committee
Name of ethics committee
Tehran University of Medical Sciences
Street address
Poursina St, Boulvar Keshavarz
City
Tehran
Postal code
Approval date
2017-04-26, 1396/02/06
Ethics committee reference number
IR.TUMS.VCR.REC.1396.2138

Health conditions studied

1

Description of health condition studied
Migraine
ICD-10 code
G43.0
ICD-10 code description
Migraine without aura

Primary outcomes

1

Description
serum levels of Malondialdehyde
Timepoint
before and after 2 months intervention
Method of measurement
ELISA (Pg/ml)

2

Description
serum levels of Glutathione peroxidase
Timepoint
before and after 2 months intervention
Method of measurement
ELISA (Pg/ml)

3

Description
serum levels of Superoxide dismutase
Timepoint
before and after 2 months intervention
Method of measurement
ELISA (Pg/ml)

Secondary outcomes

1

Description
Body Mass Index
Timepoint
befor and after 2 months intervention
Method of measurement
calculating from weight (kg)/height (m2)

2

Description
weight
Timepoint
befor and after 2 months intervention
Method of measurement
Scales (kg)

3

Description
waist circumference
Timepoint
befor and after 2 months intervention
Method of measurement
tape meter (cm)

Intervention groups

1

Description
Group 1: receiving omega-3 fatty acids capsules, 1250 twice per day with lunch, for 2 months and nano-curcumin capsule, 80 mg once per day with dinner for 2 months
Category
Treatment - Drugs

2

Description
Group 2: receiving omega-3 fatty acids capsules, 1250 twice per day with lunch, for 2 months and placebo of nano-curcumin capsule, 80 mg included oral paraffin once per day with dinner for 2 months
Category
Treatment - Drugs

3

Description
Group 3: receiving nano-curcumin capsule, 80 mg once per day with dinner for 2 months and placebo of omega-3 fatty acids capsules, 1250 mg included oral paraffin twice per day with lunch, for 2 months
Category
Treatment - Drugs

4

Description
group 4 (control): receiving placebo of omega-3 fatty acids capsules, 1250 mg included oral paraffin twice per day with lunch, for 2 months and placebo of nano-curcumin capsule, 80 mg included oral paraffin once per day with dinner for 2 months
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Iranian center of neurological researchers
Full name of responsible person
Dr. Abass Tafakhori
Street address
Imam Khomeini Hospital, Boulvar Keshavarz Terminal
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
School of Nutritional Sciences and Dietetics, Tehran University of Medical Sciences
Full name of responsible person
Ms. Fatemeh Javadi
Street address
No. 44, HojatDost alley, Naderi Street, Boulvar Keshavarz
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
School of Nutritional Sciences and Dietetics, Tehran 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
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Faculty of Nutritional Sciences and Dietetics, Tehran University of Medical Sciences
Full name of responsible person
Dr. Mina A bdolahi
Position
Ph.D in Nutrition sciences
Other areas of specialty/work
Street address
No. 44, Hojatdoust alley, Naderi Street, Boulvar Keshavarz
City
Tehran
Postal code
Phone
+98 21 8895 5975
Fax
Email
m-abdolahi@razi.tums.ac.irabdolahimina.n@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Faculty of Nutritional Sciences and Dietetics, Tehran University of Medical Sciences
Full name of responsible person
Dr. Mahmoud Djalali
Position
Ph.D in Clinical Biochemistry
Other areas of specialty/work
Street address
No. 44, Hojatdoust alley, Naderi Street, Boulvar Keshavarz
City
Tehran
Postal code
Phone
+98 21 8895 5975
Fax
Email
mjalali87@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Tehran University Medical of Sciences
Full name of responsible person
Ms. Mina Abdolahi
Position
Ph.D in Nutritional Sciences
Other areas of specialty/work
Street address
City
Tehran
Postal code
Phone
00
Fax
Email
m-abdolahi@razi.tums.ac.irabdolahimina.n@gmail.com
Web page address

Sharing plan

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