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Effect of oral Co-Q10 supplementation on nutrition status, migrane attacks, inflammatory biomarkers, oxidative stress and CGRP neuropeptide in women with migraine

Protocol summary

Summary
The aim of the current study is to determine the effect of oral Co-Q10 supplementation on nutrition status, migraine attacks, inflammatory biomarkers, oxidative stress and CGRP neuropeptide in women with migraine. Eighty four female patients with aged 18-50 years old suffering from migraine based on ICH criteria with the history of at least two episodic migraine (with or without aura) attacks per month for more than one year will be studied in a double blind randomized control clinical trial . Patients will be randomized to one of the Co-Q10 or placebo groups. Intervention duration will be three months (after a month for run-in period) and intervention group will receive 400 mg/day Co-Q10 as 2 capsules of 200 mg besides their usual anti-migraine treatments and control group will receive placebo capsules besides their usual anti-migraine drugs. Nutritional status, migraine attacks (frequency, severity and duration) with valid specific migraines questionnaires , anthropometric indexes and physical activity levels at the base, middle and at the end of the study and also inflammatory factors( TNF-α, IL-10 and IL-6), Oxidative factors (MDA, TAC), CGRP neuropeptide, lipid profile(TG, HDL-C, LDL-C and TC) and serum Co-Q10 level at the base and the end of the study will be measured.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201508265670N10
Registration date: 2015-12-29, 1394/10/08
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2015-12-29, 1394/10/08
Registrant information
Name
Ali Tarighat-Esfanjani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 914 300 5895
Email address
tarighata@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for research of Tabriz University of Medical Sciences - Nutrition Research Center
Expected recruitment start date
2015-12-21, 1394/09/30
Expected recruitment end date
2016-08-21, 1395/05/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of oral Co-Q10 supplementation on nutrition status, migrane attacks, inflammatory biomarkers, oxidative stress and CGRP neuropeptide in women with migraine
Public title
Effect of Co-Q10 in migraine
Purpose
Supportive
Inclusion/Exclusion criteria
inclusion criteria: Female; patient tendency and ability to participate in the study; age between 18-50; a definitive diagnosis of migraine based on IHS criteria; headache history for at least one year; episodic migraine with or without aura; having at least two headaches per month. Exclusion criteria: Menopause; suffering from tension type or other headaches; having chronic disease (such as diabetes, cardiovascular disease, chronic kidney disorders and functional liver disorders and cancers); having history of stroke or MI; smoking; pregnancy or intend to pregnancy or lactation; using CO-Q10 during the last three month before study; daily or almost daily using(>15/month) of narcotics; using antioxidant supplements; consuming anti-hypertention and anti-hyperlipidemia drugs.
Age
From 18 years old to 50 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 84
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Tabriz University of Medical Sciences
Street address
Tabriz University of Medical Sciences, Golgasht street, Tabriz
City
Tabriz
Postal code
Approval date
2015-12-07, 1394/09/16
Ethics committee reference number
TBZMED.REC.1394.835

Health conditions studied

1

Description of health condition studied
Migraine
ICD-10 code
G43.0, G43
ICD-10 code description
Migraine without aura [common migraine], Migraine with aura [classical migraine]

Primary outcomes

1

Description
migriane frequency
Timepoint
at the baseline, 6 and 12 weeks after the intervention
Method of measurement
questionnaire

2

Description
migraine severity
Timepoint
at the baseline, 6 and 12 weeks after the intervention
Method of measurement
questionnaire

3

Description
migraine duration
Timepoint
at the baseline, 6 and 12 weeks after the intervention
Method of measurement
questionnaire

4

Description
CGRP Neuropeptide
Timepoint
at the baselinen and 12 weeks after the intervention
Method of measurement
ELISA kit

5

Description
TNF-a
Timepoint
at the baseline and 12 weeks after the intervention
Method of measurement
ELISA kit

6

Description
IN-6
Timepoint
at the baseline and 12 weeks after the intervention
Method of measurement
ELISA kit

7

Description
IL-10
Timepoint
at the baseline and 12 weeks after the intervention
Method of measurement
ELISA kit

8

Description
TAC
Timepoint
at the baseline and 12 weeks after the intervention
Method of measurement
spectrophotometry

9

Description
MDA
Timepoint
at the baseline and 12 weeks after the intervention
Method of measurement
TBA (Thio Barbituric Acid)

10

Description
triglyceride(TG)
Timepoint
at the baseline and 12 weeks after the intervention
Method of measurement
enzymatic method

11

Description
total cholesterol (TC)
Timepoint
at the baseline and 12 weeks after the intervention
Method of measurement
anzymatic method

12

Description
high density lipoprotein cholesterol (HDL-c)
Timepoint
at the baseline and 12 weeks after the intervention
Method of measurement
anzymatic method

13

Description
low density lipoprotein cholesterol (LDL-c)
Timepoint
at the baseline and 12 weeks after the intervention
Method of measurement
Friedewald Equation

14

Description
serum Co-Q10 levels
Timepoint
at the baseline and 12 weeks after the intervention
Method of measurement
HPLC

15

Description
dietary intake
Timepoint
at the baseline, 6 and 12 weeks after the intervention
Method of measurement
3 days food record

16

Description
anthropometric measurements
Timepoint
at the baseline, 6 and 12 weeks after the intervention
Method of measurement
BMI, waist circumference and body fat percent

17

Description
Added at 2017-02-08: pyruvate
Timepoint
Added at 2017-02-08: at the baseline and 12 weeks after the intervention
Method of measurement
Added at 2017-02-08: ELISA kit

18

Description
Added at 2017-02-08: Nitric oxide
Timepoint
Added at 2017-02-08: at the baseline and 12 weeks after the intervention
Method of measurement
Added at 2017-02-08: Elisa kit

19

Description
Added at 2017-02-08: Lactate
Timepoint
Added at 2017-02-08: at the baseline and 12 weeks after the intervention
Method of measurement
Added at 2017-02-08: Elisa Kit

20

Description
Added at 2017-02-08: Matrix metalloproteinases9
Timepoint
Added at 2017-02-08: at the baseline and 12 weeks after the intervention
Method of measurement
Added at 2017-02-08: ELISA kit

Secondary outcomes

1

Description
physical activity
Timepoint
at the baseline, 6 and 12 weeks after the intervention
Method of measurement
IPAQ questionnaire

Intervention groups

1

Description
Intervention group will receive daily two 200 mg capsule of Coenzyme Q10 with meal for three months besides their usual treatments
Category
Prevention

2

Description
control group will receive daily two capsule of placebol for three months besides their usual treatments
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Golgasht Medical center
Full name of responsible person
Dr.Maziar Hashemilar
Street address
Tabriz,Golgasht st,Golgasht medical center, fourth floor
City
Tabriz

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice Chancellor for research of Tabriz University of Medical Sciences - Nutrition Research Center
Full name of responsible person
Dr. Alireza Ostadrahimi
Street address
Nutrition Faculty, Attarneyshabouri street, Golgasht street, Tabriz
City
Tabriz
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 of Tabriz University of Medical Sciences - Nutrition Research Center
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

Person responsible for scientific inquiries

Contact
Name of organization / entity
Nutrition Faculty, Tabriz University of Medical Scienses
Full name of responsible person
Dr.Ali Tarighat-Esfanjani
Position
Ph.D. of Nutrition
Other areas of specialty/work
Street address
Nutrition Faculty, Attarneyshabouri street, Golgasht street
City
Tabriz
Postal code
Phone
+98 41 3335 2292
Fax
Email
tarighata@tbzmed.ac.ir
Web page address

Person responsible for updating data

Contact

Sharing plan

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