Effect of combined supplementation Coenzyme Q10 with L-carnitine on mitochondrial metabolic disorders markers and migraine symptoms among patient with migraine by following a tyramine-controlled diet.
Evaluation the impact of combined supplementation Coenzyme Q10 with L-carnitine on mitochondrial metabolic disorders markers and migraine symptoms among patient with migraine
Design
we will enroll 56 eligible patients with migraine aged 20- 49 years that will be recruited from Imam Mousa Sadr Clinic will randomly assigned into treatment and placebo groups.
Settings and conduct
The present study is a double-blind randomized clinical trial study and participants, researcher, and statistical analyser will not know from assigned intervention. The population includes 56 patients with migraine that will be recruited from Imam Mousa Sadr Clinic. The participants will randomly assigned into treatment and placebo groups to receive Coenzyme Q10 with L-carnitine or placebo tablets for 8 weeks. migraine symptoms, depression and biochemical assessment will be measured at the beginning and end of each phases.
Participants/Inclusion and exclusion criteria
patients with migraine (with or without aura), both sex, nonpregnant, nonlactative, nonsmokers, non-alcoholic and willing to participate in the study/contain history of chronic diseases, chronic tension-type headache or secondary headaches.
Intervention groups
The treatment group will receive 30 mg/day Coenzyme Q10 with 250 mg/day L-carnitine at the same time for 8- weeks and subject in the other group also will receive the placebo tablets. Individuals in both group will receive a list of tyramine contains foods and will be asked not to consume any of these foods during the study.
Main outcome variables
Migraine symptoms ( severity , frequency and average duration of migraine attacks), Serum Lactate.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20121216011763N21
Registration date:2017-12-03, 1396/09/12
Registration timing:retrospective
Last update:2017-12-03, 1396/09/12
Update count:0
Registration date
2017-12-03, 1396/09/12
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
Isfahan University of Medical Sciences
Expected recruitment start date
2017-05-22, 1396/03/01
Expected recruitment end date
2017-08-22, 1396/05/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of combined supplementation Coenzyme Q10 with L-carnitine on mitochondrial metabolic disorders markers and migraine symptoms among patient with migraine by following a tyramine-controlled diet.
Public title
Effect of combined supplementation Coenzyme Q10 with L-carnitine on migraine
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
patients with migraine (with or without aura)
both sex
nonpregnant
nonlactative
nonsmokers
non-alcoholic
willing to participate in the study
Exclusion criteria:
contain history of chronic diseases
chronic tension-type headache or secondary headaches
medication or supplements use
following a diet program during the past 6 month
following exercise program during the past 6 month
Age
From 20 years old to 40 years old
Gender
Both
Phase
0
Groups that have been masked
Participant
Investigator
Data analyser
Sample size
Target sample size:
56
Randomization (investigator's opinion)
Randomized
Randomization description
In present study, simple randomization method will be used. The randomization unit is individually and we will use the random number table method for random sequences. A random numbered table is a collection of numbers that are without a specific pattern, completely random and as table. The next step is allocation concealment and will use sequentially numbered, sealed, opaque envelopes. Then, based on the sample size, number of envelopes with aluminum surface are provided and each random sequence created on a card and the cards are inserted into the envelopes, respectively. At the time of registration for the participants, according to eligible participants, one of the envelopes is opened and the allocated group for participants is revealed.
Blinding (investigator's opinion)
Double blinded
Blinding description
The present study is a double blind method and participants, researcher, and statistical analyser will not know according to assigned intervention.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethical Committee of Isfahan University of Medical Sciences
Street address
Isfahan University of Medical Sciences, Hezar Jerib Avenue
City
Isfahan
Province
Isfehan
Postal code
8135798111
Approval date
2017-05-01, 1396/02/11
Ethics committee reference number
IR.MUI.REC.1396.3.054
Health conditions studied
1
Description of health condition studied
migraine
ICD-10 code
G43.9
ICD-10 code description
Migraine, unspecified
Primary outcomes
1
Description
Migraine symptoms ( severity , frequency and average duration of migraine attacks)
Timepoint
week 0 and week 8
Method of measurement
Questionaire
2
Description
Serum Lactate
Timepoint
week 0 and week 8
Method of measurement
Laboratory analysis (blood test)
Secondary outcomes
1
Description
Migraine Disability Assessment
Timepoint
week 0 and week 8
Method of measurement
Questinaire
2
Description
Depression
Timepoint
week 0 and week 8
Method of measurement
Questinaire
Intervention groups
1
Description
Intervention group: 30 mg/day Coenzyme Q10 with 250 mg/day L-carnitine at the same time for 8- weeks
control group: placebo tablets for 8 weeks
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Mousa Sadr Clinic
Full name of responsible person
Parisa Hashemi
Street address
Isfahan University of Medical Sciences, Hezar Jerib Avenue
City
Isfahan
Province
Isfehan
Postal code
8135798111
Phone
+98 31 3792 3172
Email
hashemi_p@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Amir mansour alavi
Street address
Hezarjarib streetو Isfahan University of Medical Sciences
City
Isfahan
Province
Isfehan
Postal code
8135798111
Phone
+98 31 3792 3175
Email
am.alavi@nutr.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
Isfahan University of Medical Sciences
Full name of responsible person
Parisa Hashemi
Position
PhD candidate
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Hezarjarib streetو Isfahan University of Medical Sciences
City
Isfahan
Province
Isfehan
Postal code
8135798111
Phone
+98 31 3792 3171
Fax
Email
hashemi_p@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Mojgan nourian
Position
PhD of Nutrition sciences
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Hezarjarib streetو Isfahan University of Medical Sciences
City
Isfahan
Province
Isfehan
Postal code
8135798111
Phone
+98 31 3792 3172
Fax
Email
nourian@hlth.mui.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Isfahan university of medical sciences
Full name of responsible person
Parisa Hashemi
Position
PhD candidate
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Isfahan University of Medical Sciences, Hezar Jerib Avenue
City
Isfahan
Province
Isfehan
Postal code
8135798111
Phone
+98 31 3792 3172
Fax
Email
hashemi_p@yahoo.com
Web page address
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