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Investigating the effect of co-supplementation with alpha-linolenic acid and L-carnitine on inflammatory status, oxidative stress, clinical symptoms, mental health and quality of life in women with migraine

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History
# Registration date Revision Id
3 2024-09-08, 1403/06/18 313750
2 2023-09-17, 1402/06/26 289269
1 2023-03-29, 1402/01/09 260078
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  • Protocol summary

    A controlled, randomized, triple-blind clinical trial with parallel groups, phase 3 on 80 women with migraine. Randomization based on the permuted blocks randomization according to age and body mass index
    A controlled, randomized, triple-blind clinical trial with parallel groups, phase 3 on 80 women with migraine. Randomization based on the permuted blocks randomization according to age
    کارآزمایی بالینی شاهدار، تصادفی، سه سو کور از نوع گروه‌های موازی، فاز 3 بر روی 80 خانم مبتلا به میگرن. تصادفی سازی به روش بلوک های جایگشتی بر اساس سن و نمایه توده بدنی
    کارآزمایی بالینی شاهدار، تصادفی، سه سو کور از نوع گروه‌های موازی، فاز 3 بر روی 80 خانم مبتلا به میگرن. تصادفی سازی به روش بلوک های جایگشتی بر اساس سن
    Intervention: Daily supplement of alpha-linolenic acid (1000 mg of flaxseed oil, one capsule containing 350 mg of alpha-linolenic acid, Barij company) and supplement of L-carnitine (500 mg of L-carnitine, one tablet, Behta Daro company) Control group: Alpha-linolenic acid placebo (parafin oil, one capsul) and L-carnitine placebo (corn starch, one tablet) The duration of the intervention: 12 weeks
    Intervention: Daily supplement of alpha-linolenic acid (1000 mg of flaxseed oil, one capsule containing 350 mg of alpha-linolenic acid, Barij company) and supplement of L-carnitine (500 mg of L-carnitine, one tablet, Behta Daro company) Control group: Alpha-linolenic acid placebo (parafin oil, one capsul) and L-carnitine placebo (maltodextrin, one tablet) The duration of the intervention: 12 weeks
    مداخله: روزانه مکمل آلفالینولنیک اسید ( 1000 میلی‌گرم روغن بذر کتان، یک کپسول حاوی 350 میلی‌گرم آلفالینولنیک اسید، محصول شرکت باریج ) و مکمل ال-کارنیتین (500 میلی‌گرم ال-کارنیتین، یک قرص، محصول شرکت بهتا دارو) گروه کنترل: پلاسبوی آلفالینولنیک اسید (روغن پارافین، یک کپسول) و پلاسبوی ال-کارنیتین (نشاسته ذرت، یک قرص) طول مدت مداخله: 12 هفته
    مداخله: روزانه مکمل آلفالینولنیک اسید ( 1000 میلی‌گرم روغن بذر کتان، یک کپسول حاوی 350 میلی‌گرم آلفالینولنیک اسید، محصول شرکت باریج ) و مکمل ال-کارنیتین (500 میلی‌گرم ال-کارنیتین، یک قرص، محصول شرکت بهتا دارو) گروه کنترل: پلاسبوی آلفالینولنیک اسید (روغن پارافین، یک کپسول) و پلاسبوی ال-کارنیتین (مالتودکسترین، یک قرص) طول مدت مداخله: 12 هفته

  • General information

    Reducing the sample size due to time and financial limitations and the small number of patients based on the inclusion and exclusion criteria
    Changing the block criteria in the randomization of participants
    کاهش حجم نمونه به دلیل محدودیت زمانی و مالی و تعداد کم بیماران بر اساس معیارهای ورود و خروج
    تغییر معیارهای بلوک بندی در تصادفی سازی شرکت کنندگان
    The samples will be randomly placed in one of the four intervention or control groups using permuted block randomization, with blocks of 4. In order to distribute patients into intervention and control groups, first, people are classified into four states in terms of age (less than 35 years/35 years and older) and body mass index (less than 30 and more than 30). Then, people with the same conditions will be randomly assigned to one of the intervention and control groups. Also, the researcher evaluating the intended outcomes is unaware of the random allocation process and the type of treatment performed.
    The samples will be randomly placed in one of the four intervention or control groups using permuted block randomization, with blocks of 4. In order to distribute patients into intervention and control groups, first, people are classified into two states in terms of age (less than 35 years/35 years and older). Then, people with the same conditions will be randomly assigned to one of the intervention and control groups. Also, the researcher evaluating the intended outcomes is unaware of the random allocation process and the type of treatment performed.
    نمونه‌ها به صورت تصادفی به روش بلوک‌های جایگشتی با بلوک‌هایی به حجم 4 در یکی از چهار گروه مداخله یا کنترل قرار می گیرند. به منظور توزیع بیماران در گروه های مداخله و کنترل، ابتدا افراد از نظر سن (کمتر از 35 سال/ 35 سال و بالاتر) و نمایه توده بدنی (کمتر از 30 و بیشتر از 30) به چهار حالت طبقه بندی می شوند. سپس، افراد با حالت های یکسان به صورت تصادفی در یکی از گروه های مداخله و کنترل قرار خواهند گرفت. همچنین محقق ارزیابی‌کننده پیامدهای موردنظر از فرایند تخصیص تصادفی و نوع درمان انجام‌شده بی‌خبر است.
    نمونه‌ها به صورت تصادفی به روش بلوک‌های جایگشتی با بلوک‌هایی به حجم 4 در یکی از چهار گروه مداخله یا کنترل قرار می گیرند. به منظور توزیع بیماران در گروه های مداخله و کنترل، ابتدا افراد از نظر سن (کمتر از 35 سال/ 35 سال و بالاتر) به دو حالت طبقه بندی می شوند. سپس، افراد با حالت های یکسان به صورت تصادفی در یکی از گروه های مداخله و کنترل قرار خواهند گرفت. همچنین محقق ارزیابی‌کننده پیامدهای موردنظر از فرایند تخصیص تصادفی و نوع درمان انجام‌شده بی‌خبر است.

  • Primary outcomes

    #1
    Total oxidant status
    total antioxidant capacity
    وضعیت تام اکسیدانی
    ظرفیت تام آنتی اکسیدانی

  • Intervention groups

    #1
    Control group: Alpha-linolenic acid placebo (paraffin oil, one 1000 mg capsule per day) and L-carnitine placebo (corn starch, one 500 mg tablet per day)
    Control group: Alpha-linolenic acid placebo (paraffin oil, one 1000 mg capsule per day) and L-carnitine placebo (maltodextrin, one 500 mg tablet per day)
    گروه کنترل: پلاسبوی آلفالینولنیک اسید (روغن پارافین، یک کپسول 1000 میلی گرمی در روز) و پلاسبوی ال-کارنیتین (نشاسته ذرت، یک قرص 500 میلی گرمی در روز)
    گروه کنترل: پلاسبوی آلفالینولنیک اسید (روغن پارافین، یک کپسول 1000 میلی گرمی در روز) و پلاسبوی ال-کارنیتین (مالتودکسترین، یک قرص 500 میلی گرمی در روز)

Protocol summary

Study aim
Investigating the effect of co-supplementation with alpha-linolenic acid and L-carnitine on inflammatory status, oxidative stress, clinical symptoms, mental health and quality of life in women with migraine
Design
A controlled, randomized, triple-blind clinical trial with parallel groups, phase 3 on 80 women with migraine. Randomization based on the permuted blocks randomization according to age
Settings and conduct
The participants will be selected from women migraine patients who refer to the neurologist's office in Isfahan city. At the beginning and end of the study, venous blood samples, anthropometric measurements, questionnaires related to migraine, demographic information and socio-economic status of patients will be measured and recorded.
Participants/Inclusion and exclusion criteria
Inclusion criteria: willingness to participate in the study, diagnosed with migraine by a neurologist, age 20 to 50 years, at least one year has passed after migraine diagnosis. Exclusion criteria: Migraine with aura, suffering from chronic diseases, pregnancy and lactation, taking nutritional supplements in the past 3 months, taking anticoagulants, smoking, and following a special diet.
Intervention groups
Intervention: Daily supplement of alpha-linolenic acid (1000 mg of flaxseed oil, one capsule containing 350 mg of alpha-linolenic acid, Barij company) and supplement of L-carnitine (500 mg of L-carnitine, one tablet, Behta Daro company) Control group: Alpha-linolenic acid placebo (parafin oil, one capsul) and L-carnitine placebo (maltodextrin, one tablet) The duration of the intervention: 12 weeks
Main outcome variables
Clinical symptoms of migraine, oxidative stress and inflammatory status, mental health and quality of life

General information

Reason for update
Changing the block criteria in the randomization of participants
Acronym
IRCT registration information
IRCT registration number: IRCT20121216011763N57
Registration date: 2023-03-29, 1402/01/09
Registration timing: prospective

Last update: 2024-09-08, 1403/06/18
Update count: 2
Registration date
2023-03-29, 1402/01/09
Registrant information
Name
Gholamreza Askari
Name of organization / entity
Isfahan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 1792 2110
Email address
askari@mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-05-06, 1402/02/16
Expected recruitment end date
2023-11-21, 1402/08/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of co-supplementation with alpha-linolenic acid and L-carnitine on inflammatory status, oxidative stress, clinical symptoms, mental health and quality of life in women with migraine
Public title
The effect of co-supplementation with alpha-linolenic acid and L-carnitine in migraine
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients who are willing to participate in the study Migraine diagnosis by a neurologist based on the International Classification of Headache Disorders-3 (ICHD-3) Age 20 to 50 years At least one year has passed since the migraine diagnosis
Exclusion criteria:
Migraine with aura Suffering from cardiovascular diseases, hypertension, diabetes, liver and kidney diseases, malignancies and other neurological disorders Pregnancy and lactation Taking nutritional supplements (including riboflavin, feverfew, magnesium and coenzyme Q10 in the last 3 months) Taking anticoagulants Following a special diet Smoking
Age
From 20 years old to 50 years old
Gender
Female
Phase
3
Groups that have been masked
  • Participant
  • Investigator
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 80
Randomization (investigator's opinion)
Randomized
Randomization description
The samples will be randomly placed in one of the four intervention or control groups using permuted block randomization, with blocks of 4. In order to distribute patients into intervention and control groups, first, people are classified into two states in terms of age (less than 35 years/35 years and older). Then, people with the same conditions will be randomly assigned to one of the intervention and control groups. Also, the researcher evaluating the intended outcomes is unaware of the random allocation process and the type of treatment performed.
Blinding (investigator's opinion)
Triple blinded
Blinding description
The study will be conducted as a three-blind study as follows: Medicines and placebo will be provided to all groups in completely identical containers without name labels, prepared in the same color and smell, and coded based on random allocation by the researcher. Therefore, none of the patients were aware of the assigned treatment and will not be informed until the end of the study. Also, the researcher evaluating the intended outcomes is unaware of the random allocation process and the type of treatment performed.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Isfahan University of Medical Sciences
Street address
Isfahan University of Medical Sciences, Hezar Jerib street, Isfahan, Iran
City
Isfahan
Province
Isfehan
Postal code
8174673461
Approval date
2023-03-12, 1401/12/21
Ethics committee reference number
IR.MUI.RESEARCH.REC.1401.406

Health conditions studied

1

Description of health condition studied
Migraine
ICD-10 code
Migraine w
ICD-10 code description
G43.0

Primary outcomes

1

Description
clinical symptoms of migraine (severity, frequency, duration of migraine attacks)
Timepoint
At baseline and after 12 weeks
Method of measurement
Visual Analogue Scale (VAS) questionnaire and clinical examination

2

Description
Serum levels of C-reactive protein (CRP)
Timepoint
At baseline and after 12 weeks
Method of measurement
Enzyme-linked immunosorbent assay (ELISA) kits

3

Description
serum level of superoxide dismutase (SOD)
Timepoint
At baseline and after 12 weeks
Method of measurement
biochemical kit of KiaZist Co.

4

Description
Serum level of malondialdehyde (MDA)
Timepoint
At baseline and after 12 weeks
Method of measurement
biochemical kit of KiaZist Co.

5

Description
total antioxidant capacity
Timepoint
At baseline and after 12 weeks
Method of measurement
biochemical kit of KiaZist Co.

6

Description
Serum level of Nitric Oxide
Timepoint
At baseline and after 12 weeks
Method of measurement
biochemical kit of KiaZist Co.

7

Description
Mental health (Stress, anxiety, depression)
Timepoint
At baseline and after 12 weeks
Method of measurement
Depressionو Anxiety and Stress Scale-21 questionnaire (DASS-21)

8

Description
Quality of Life of Migraine Patients
Timepoint
At baseline and after 12 weeks
Method of measurement
Migraine –Specific Quality of Life (MSQ) questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: An alphal-inolenic acid supplement (daily 1000 mg flaxseed oil, one capsule containing 350 mg alphalinolenic acid) and L-carnitine supplement (500 mg L-carnitine)
Category
Treatment - Drugs

2

Description
Control group: Alpha-linolenic acid placebo (paraffin oil, one 1000 mg capsule per day) and L-carnitine placebo (maltodextrin, one 500 mg tablet per day)
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Neurologist's office located in Isfahan Khurshid Clinic
Full name of responsible person
Dr. Gholamreza Askari
Street address
khorshid medical educational research complex, Ostandari Street, Isfahan
City
Isfahan
Province
Isfehan
Postal code
8145833117
Phone
+98 31 3222 2127
Email
Askari@mui.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Dr. Gholamreza Askari
Street address
Deputy of Research & Technology of Isfahan University of Medical Sciences, Hezar Jarib Street, Isfahan
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 3060
Email
askari@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. Gholamreza Askari
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Deputy of Research & Technology of Isfahan University of Medical Sciences, Hezar Jarib Street, Isfahan
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
009837923060
Email
askari@mui.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Dr. Gholamreza Askari
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Deputy of Research & Technology of Isfahan University of Medical Sciences, Hezar Jarib Street, Isfahan
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 3060
Email
askari@mui.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Dr. Gholamreza Askari
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Deputy of Research & Technology of Isfahan University of Medical Sciences, Hezar Jarib Street, Isfahan
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 3060
Email
askari@mui.ac.ir

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
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be 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
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
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