The effect of concurrent curcumin and vitamin D supplementation on headache symptoms and calcitonin gene-related peptide level (CGRP) in patients with migraine
The effect of concurrent curcumin and vitamin D supplementation on headache symptoms and calcitonin gene-related peptide level (CGRP) in patients with migraine
Design
Randomized clinical trial
Settings and conduct
Migraine patients who refer to clinics affiliated to Shahrekord University of Medical Sciences are treated with curcumin and vitamin D supplements.
Participants/Inclusion and exclusion criteria
1.Willingness to cooperate with the plan ۲. Diagnosis of migraine by a neurologist based on ICHD-3 criteria. 3. Age 20 to 50 years. 4. No chronic diseases 5. Absence during pregnancy and lactation .. Taking dietary supplements or medication (nutritional supplements, multivitamin mineral and W3 supplements or anti-migraine medications (valproate, amitriptyline, etc.), anti-inflammatory and anti-depressant pills, Aspirin and NSAIDs, contraceptives in the last three months 6. No alcohol and smoking Exclusion criteria: 1. Failure to follow the recommendations and diet. ۲. Failure to refer the person at different stages of the study. 3. Cardiovascular disease, hypertension, diabetes, liver, kidney, thyroid, malignancies and other neurological disorders. 4. Taking nutritional and herbal supplements that affect migraines
Intervention groups
"Intervention group": migraine patients intake curcumin supplement in the form of 500 mg capsules, one per day with routine treatment(Two 200 mg sodium valproate tablets and two 20 mg propranolol tablets) and a soft oral vitamin D capsule with a dose of 2000 international units daily. "Control group": migraine patients intake placebo of curcumin and vitamin D supplement one per day with routine treatment (Two 200 mg sodium valproate tablets and two 20 mg propranolol tablets).
The effect of concurrent curcumin and vitamin D supplementation on headache symptoms and calcitonin gene-related peptide level (CGRP) in patients with migraine
Public title
The effect of curcumin and vitamin D s on headache symptoms and inflammation in patients with migraine
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Willingness to cooperate with the plan
Diagnosis of migraine by a neurologist based on ICHD-3 criteria.
Age 20 to 50 years.
No chronic diseases (liver, kidney, cardiovascular disease, secondary headache or other types of primary headache except migraine)
Absence during pregnancy and lactation
No taking dietary supplements or medication (nutritional supplements, multivitamin mineral and W3 supplements or anti-migraine medications (valproate, amitriptyline, etc.), anti-inflammatory and anti-depressant pills, Aspirin and NSAIDs, contraceptives in the last three months
Failure to follow a specific diet or exercise program during the last three months
Exclusion criteria:
alcohol and smoking
Age
From 20 years old to 50 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Eligible subject be selected with convenience sampling and be randomly assigned into 2 groups of 25 subjects as treatment and control with block sizes of 3 and 6 with proportion 1:1. A person from research team not involved in the recruitment and assigning participants generate allocation sequence using web site of www.Randomization.com.
Blinding (investigator's opinion)
Double blinded
Blinding description
After explaining the purpose of the study, all participants and investigators are blinded to random allocation. Participants in vitamin D group receive vitamin D 1000 IU supplement and curcumin capsules while control group take placebo with the same size and color as vitamin D(Oral paraffin) soft gels and curcumin.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Shahrekord University of Medical Science
Street address
Kashani Street
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
۸۸۱۳۸۳۳۴۳۵
Approval date
2021-05-11, 1400/02/21
Ethics committee reference number
IR.SKUMS.REC.1400.047
Health conditions studied
1
Description of health condition studied
Migraine
ICD-10 code
G43
ICD-10 code description
Migraine without aura [common migraine]
Primary outcomes
1
Description
Severity of migraine
Timepoint
Before the intervention and at the end of the study
Method of measurement
Visual Analogue Scale
2
Description
Migraine frequency
Timepoint
Before the intervention and at the end of the study
Method of measurement
Question / Number of attacks per month
3
Description
Duration of migraine headache
Timepoint
Before the intervention and at the end of the study
Method of measurement
Question / Number of attacks per month
4
Description
The degree of disability caused by migraines
Timepoint
Before the intervention and at the end of the study
Method of measurement
Headache Impact Test Questionnaire
5
Description
Calcitonin gene-related peptide
Timepoint
Before the intervention and at the end of the study
Method of measurement
blood test
Secondary outcomes
empty
Intervention groups
1
Description
"Intervention group": migraine patients intake curcumin supplement in the form of 500 mg capsules from Karen Company, one per day with routine treatment (200 mg sodium valproate tablets from Sajad Darou 2/day and two 20 mg propranolol tablets from Tolid Darou) and a soft oral vitamin D capsule with a dose of 2000 international units produce by Zahravi Company daily for 60 days.
Category
Treatment - Other
2
Description
"Control group": migraine patients intake placebo of curcumin and vitamin D supplement one per day with routine treatment (two 200 mg sodium valproate tablets and two 20 mg propranolol tablets) for 60 days.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Clinic Affiliated to Shahrekord University of Medical Sciences
Full name of responsible person
Siavash Fazelian
Street address
Kashani Streets
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
88138334335
Phone
+98 38 3333 5652
Email
Siavashfazelian@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahre-kord University of Medical Sciences
Full name of responsible person
Mehraban Sadeghi
Street address
Kashani Street, Vice Chancellor of Research and Technology Shahrekord University of Medical Sciences
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
۸۸۱۵۷۱۳۴۷۱
Phone
+98 38 3334 2414
Email
Siavashfazelian@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahre-kord 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
Shahre-kord University of Medical Sciences
Full name of responsible person
Siavash Fazelian
Position
PhD in Nutrition
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Kashani Street
City
Shahrekod
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8813833435
Phone
+98 912 839 0366
Email
Siavashfazelian@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahre-kord University of Medical Sciences
Full name of responsible person
Siavash Fazelian
Position
PhD in Nutrition
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Kashani Street
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
۸۸۱۳۸۳۳۴۳۵
Phone
+98 912 839 0366
Email
Siavashfazelian@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Shahre-kord University of Medical Sciences
Full name of responsible person
Siavash Fazelian
Position
PhD in Nutrition
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Kashani Street
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8813833435
Phone
+98 912 839 0366
Email
Siavashfazelian@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
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