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The effects of alpha-lipoic acid supplementation on oxidative stress status, inflammatory markers, VCAM-I serum levels, lactate and clinical symptoms in women with migraine.

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History
# Registration date Revision Id
2 2021-04-05, 1400/01/16 177396
1 2020-11-09, 1399/08/19 158045
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  • Primary outcomes

    #1
    empty
    C-reactive protein (CRP)
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    پروتئین واکنشی C
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    At baseline and after 3 month.
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    ابتدا و 3 ماه پس از شروع مداخله.
    empty
    Colorimetric method.
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    روش رنگ سنجی
    #2
    empty
    Serum glutathion
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    گلوتاتیون سرم
    empty
    At baseline and after 3 month.
    empty
    ابتدا و 3 ماه پس از شروع مداخله.
    empty
    Colorimetric method.
    empty
    روش رنگ سنجی.
    #3
    empty
    Total antioxidant capacity
    empty
    ظرفیت تام آنتی اکسیدانی
    empty
    At baseline and after 3 month.
    empty
    ابتدا و 3 ماه پس از شروع مداخله.
    empty
    Colorimetric method.
    empty
    روش رنگ سنجی.
    #4
    empty
    Total oxidant capacity
    empty
    ظرفیت تام اکسیدانی
    empty
    At baseline and after 3 month.
    empty
    ابتدا و 3 ماه پس از شروع مداخله.
    empty
    Colorimetric method.
    empty
    روش رنگ سنجی.
    #5
    empty
    Malondialdehyde
    empty
    مالون دی آلدهید
    empty
    At baseline and after 3 month.
    empty
    ابتدا و 3 ماه پس از شروع مداخله.
    empty
    Colorimetric method.
    empty
    روش رنگ سنجی.

  • Secondary outcomes

    #1
    Total antioxidant capacity
    Depression
    ظرفیت تام آنتی اکسیدانی
    افسردگی
    Colorimetric method.
    DASS questionnaire
    روش رنگ سنجی.
    پرسشنامه DASS
    #2
    Total oxidant capacity
    Anxiety
    ظرفیت تام اکسیدانی
    اضطراب
    Colorimetric method.
    DASS questionnaire
    روش رنگ سنجی.
    پرسشنامه DASS
    #3
    empty
    Stress
    empty
    استرس
    empty
    At baseline and after 3 month.
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    در شروع مطالعه و 3 ماه پس از شروع مداخله.
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    DASS questionnaire.
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    پرسشنامه DASS

  • Recruitment centers

    #1
    Name of recruitment center - English: Imam Musa Sadr Clinic in Isfahan
    Name of recruitment center - Persian: کلینیک درمانی امام موسی صدر اصفهان
    Full name of responsible person - English: Dr. Fariborz Khorvash neurologist
    Full name of responsible person - Persian: دکتر فریبرز خوروش متخصص مغز و اعصاب
    Street address - English: Republic Square - Foroughi Street
    Street address - Persian: میدان جمهوری- خیابان فروغی
    City - English: Isfahan
    City - Persian: اصفهان
    Province: Isfehan
    Country: Iran (Islamic Republic of)
    Postal code: 8174673461
    Phone: +98 31 1792 2110
    Fax:
    Email: am.alavi@nutr.mui.ac.ir
    Web page address:
    Name of recruitment center - English: Imam Musa Sadr Clinic in Isfahan
    Name of recruitment center - Persian: کلینیک درمانی امام موسی صدر اصفهان
    Full name of responsible person - English: Dr. Fariborz Khorvash neurologist
    Full name of responsible person - Persian: دکتر فریبرز خوروش متخصص مغز و اعصاب
    Street address - English: Foroughi Street
    Street address - Persian: خیابان فروغی
    City - English: Isfahan
    City - Persian: اصفهان
    Province: Isfehan
    Country: Iran (Islamic Republic of)
    Postal code: 8174673461
    Phone: +98 31 1792 2110
    Fax:
    Email: am.alavi@nutr.mui.ac.ir
    Web page address:

  • Sponsors / Funding sources

    #1

    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: دکتر شقایق حق جوی جوانمرد
    Full name of responsible person - Persian: Dr. Shaghayegh Haghjoi Javanmard
    Street address - English: Azadi Square - Hezar Jerib St. - Isfahan University of Medical Sciences
    Street address - Persian: میدان آزادی - خیابان هزار جریب- دانشگاه علوم پزشکی اصفهان
    City - English: Isfahan
    City - Persian: اصفهان
    Province: Isfehan
    Country: Iran (Islamic Republic of)
    Postal code: 81746-73461
    Phone: +98 31 3668 8138
    Fax:
    Email: sh_haghjoo@med.mui.ac.ir
    Web page address:

    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: Dr Shaghayegh Haghjoi Javanmard
    Full name of responsible person - Persian: دکتر شقایق حق جوی جوانمرد
    Street address - English: Hezarjarib Ave
    Street address - Persian: خیابان هزار جریب
    City - English: Isfahan
    City - Persian: اصفهان
    Province: Isfehan
    Country: Iran (Islamic Republic of)
    Postal code: 81746-73461
    Phone: +98 31 3668 8138
    Fax:
    Email: sh_haghjoo@med.mui.ac.ir
    Web page address:

Protocol summary

Study aim
The effect of alpha-lipoic acid supplementation on the clinical symptoms of migraine, serum lactate levels, vascular adhesion molecule, oxidative status, nitric oxide, in women with migraine
Design
Two arm parallel group randomized trial with blinded postoperative care and outcome assessment.
Settings and conduct
Participants will be selected from among women with migraines who go to the special clinic of Imam Musa Sadr Hospital in Isfahan. According to the case file of the sick people, the patients will be examined according to the criteria for entering the study and the people who have the conditions to participate in the study will enter the study. The study was two-way blind.
Participants/Inclusion and exclusion criteria
Inclusion criteria: 1) Willingness to participation in the study; 2) Diagnosis of migraine by a neurologist based on ICHD-3 criteria. 3)Age 20 to 50 years. Exclusion criteria: 1) History of any allergies, intolerances or harmful drug reactions to the supplement under study 2) History of intestinal bypass.
Intervention groups
Patients in the intervention group will receive 300 mg alpha-lipoic acid twice a day and control group will receive placebo.
Main outcome variables
The effects of Alpha-lipoic acid supplement on clinical signs of migraine (severity , frequency and duration), MHI, HIT-6, Nitric oxide, Lactate, VCAM-I, Oxidative status, in woman with migraine is assessed.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20161203031212N3
Registration date: 2020-11-09, 1399/08/19
Registration timing: registered_while_recruiting

Last update: 2021-04-05, 1400/01/16
Update count: 1
Registration date
2020-11-09, 1399/08/19
Registrant information
Name
Forugh Fasihi
Name of organization / entity
Isfahan University of Medical Sciences, School of Nutrition and Food Sciences, Dept
Country
Iran (Islamic Republic of)
Phone
+98 21 4426 7331
Email address
am.alavi@nutr.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-10-22, 1399/08/01
Expected recruitment end date
2020-11-21, 1399/09/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effects of alpha-lipoic acid supplementation on oxidative stress status, inflammatory markers, VCAM-I serum levels, lactate and clinical symptoms in women with migraine.
Public title
The effect of alpha-lipoic acid on migraine.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Willingness to participation in the study. Diagnosis of migraine by a neurologist based on ICHD-3 criteria. Age 20 to 50 years. Non-menopausal women.
Exclusion criteria:
History of any allergies, intolerances or adverse drug reactions to the supplement. Pregnancy and lactation. History of intestinal bypass. Follow a special diet for the past 6 months. Smoking or alcohol. Take any supplements. Cardiovascular disease, diabetes, liver, kidney, thyroid, malignant disease and other neurological disorders are diagnosed based on the patient interview. Start taking the new drug within the last 1 month
Age
From 20 years old to 50 years old
Gender
Female
Phase
3
Groups that have been masked
  • Participant
  • Care provider
  • Investigator
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 90
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization will conduct based on permuted block randomization method. Each block will have capacity for 4 subjects. Randomization within each block will be done based on a table of random numbers using a valid random number generation website.Reputable website for generating random numbers: https://www.sealedenvelope.com/simple-randomiser/v1/lists
Blinding (investigator's opinion)
Double blinded
Blinding description
Supplementary and placebo packages will be prepared and coded by Raha Pharmaceutical Company and are completely the same in terms of all appearance, color, smell and label, and each patient is randomly assigned a number using the order obtained from the reputable website. And the researcher and patients will not be informed of the contents of the packages until the end of the study.
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 Isfahan University of Medical Sciences
Street address
Hezarjarib street
City
Isfahan
Province
Isfehan
Postal code
8174673461
Approval date
2020-10-11, 1399/07/20
Ethics committee reference number
IR.MUI.RESEARCH.REC.1399.436

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
Migraine severity
Timepoint
At baseline and after 3 month.
Method of measurement
Visual analogue scale

2

Description
Migraine frequency .
Timepoint
At baseline and after 3 month.
Method of measurement
Clinical examination.

3

Description
Migraine duration
Timepoint
At baseline and after 3 month.
Method of measurement
Clinical examination.

4

Description
Headache impact test
Timepoint
At baseline and after 3 month.
Method of measurement
HIT questionnaire

5

Description
C-reactive protein (CRP)
Timepoint
At baseline and after 3 month.
Method of measurement
Colorimetric method.

6

Description
Serum glutathion
Timepoint
At baseline and after 3 month.
Method of measurement
Colorimetric method.

7

Description
Total antioxidant capacity
Timepoint
At baseline and after 3 month.
Method of measurement
Colorimetric method.

8

Description
Total oxidant capacity
Timepoint
At baseline and after 3 month.
Method of measurement
Colorimetric method.

9

Description
Malondialdehyde
Timepoint
At baseline and after 3 month.
Method of measurement
Colorimetric method.

Secondary outcomes

1

Description
vascular cell adhesion molecule-1
Timepoint
At baseline and after 3 month.
Method of measurement
It will be measured by ELISA kit.

2

Description
Serum lactate
Timepoint
At baseline and after 3 month.
Method of measurement
Colorimetric method.

3

Description
Serum Nitric Oxide
Timepoint
At baseline and after 3 month.
Method of measurement
Colorimetric method.

4

Description
Depression
Timepoint
At baseline and after 3 month.
Method of measurement
DASS questionnaire

5

Description
Anxiety
Timepoint
At baseline and after 3 month.
Method of measurement
DASS questionnaire

6

Description
Stress
Timepoint
At baseline and after 3 month.
Method of measurement
DASS questionnaire.

Intervention groups

1

Description
People will receive 300 mg of alpha-lipoic acid supplement twice a day for 3 months. The supplement and placebo will be provided by Raha Pharmaceutical Company.
Category
Treatment - Other

2

Description
The control group will receive an alpha-lipoic acid placebo twice daily for 3 months. Supplements and placebo will be provided by Raha Pharmaceutical Company.
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Imam Musa Sadr Clinic in Isfahan
Full name of responsible person
Dr. Fariborz Khorvash neurologist
Street address
Foroughi Street
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 1792 2110
Email
am.alavi@nutr.mui.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Dr Shaghayegh Haghjoi Javanmard
Street address
Hezarjarib Ave
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Phone
+98 31 3668 8138
Email
sh_haghjoo@med.mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Dr Amir Mansour Alavi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Hezarjarib Ave
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Phone
+98 31 3792 3154
Email
am.alavi@nutr.mui.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Dr Amir Mansour Alavi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Hezarjarib Ave
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Phone
37923154
Email
am.alavi@nutr.mui.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Mahnaz Rezaei
Position
PhD student
Latest degree
Master
Other areas of specialty/work
Nutrition
Street address
Hezarjarib Ave
City
Isfahan
Province
Isfehan
Postal code
84561-16666
Phone
+98 31 3748 4152
Email
m.rezaei81@yahoo.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
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