1. Home
  2. Approved trials
  3. » فارسی

Evaluating the effects of viamin D on CGRP levels, inflammatory markers, Treg/Th17 balance and episodic migraine characteristics in Adult migraineurs

Protocol summary

Study aim
To determine the effects of vitamin D compared to placebo on CGRP levels, inflammatory markers, Treg/Th17 balance and episodic migraine characteristics in Adults migraine
Design
The present study will be conducted as a 16-week phase 1 randomized double-blind placebo-controlled trial on 80 episodic migraineurs allocated in 2 parallel groups each consisted of 40 episodic migraine patients who will receive vitamin D or placebo. From the beginning of the study, A and B codes are available to researchers to recruit the patients using twenty 4-Block Randomizations.
Settings and conduct
The study will perform at the tertiary headache clinic of Sina University Hospital. Information on demographic data and headache characteristics will be collected. A blood sample will be taken at 8 cc. Patients will be randomized to either the intervention or placebo group at the beginning of the fifth week for 12 weeks.
Participants/Inclusion and exclusion criteria
episodic migraine patients according to ICHDIII criteria aged 18 to 45 years
Intervention groups
Patients in the intervention group will receive 1 capsule containing 2,000 IU of vitamin D per day in addition to routine medications prescribed by our study neurologist. While the placebo group will receive 1 placebo capsule which will be indistinguishable from vitamin D capsules in taste and appearance. Patients will be asked to not change their medications during the study.
Main outcome variables
headache attack frequency per month; headache severity (VAS); attack duration (min per month)

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20151128025267N6
Registration date: 2018-07-11, 1397/04/20
Registration timing: registered_while_recruiting

Last update: 2018-07-11, 1397/04/20
Update count: 0
Registration date
2018-07-11, 1397/04/20
Registrant information
Name
Maryam Mahmoudi
Name of organization / entity
School of Nutritional Sciences & Dietetics, Tehran University of Medical Sciences,
Country
Iran (Islamic Republic of)
Phone
+98 21 8895 5975
Email address
m-mahmoudi@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-06-22, 1397/04/01
Expected recruitment end date
2020-02-20, 1398/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluating the effects of viamin D on CGRP levels, inflammatory markers, Treg/Th17 balance and episodic migraine characteristics in Adult migraineurs
Public title
Evaluating the effects of vitamin D on migraine headache and its possible associated factors
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
having BMI between 18.5-30 kg/m2 Migraine diagnosis according to The International Classification of Headache Disorders 3rd edition having 3-15 migraine headache attacks in last 3 months suffering from migraine for at least 6 months prior to study
Exclusion criteria:
unwillingness to participate in the study daily consumption of NSAIDs in 3 months prior to study taking vitamin D supplements in 3 months prior to study taking magnesium, calcium, zinc, vitamin B groups and vitamin C supplements during the study period taking anti-epileptic drugs such as topiramate, sodium valproate and carbamazepine taking thiazide diuretics, Glucocorticoid, statins and orlistat taking anti-psychotic drugs menopause pregnancy and lactation suffering from gastrointestinal disorders (IBD, IBS,...), liver and kidney disorders, cancer, Sarcoidosis, rickets, and osteomalacia based on physician diagnosis and/or past medical history
Age
From 18 years old to 45 years old
Gender
Both
Phase
0
Groups that have been masked
  • Participant
  • Care provider
  • Investigator
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 80
Randomization (investigator's opinion)
Randomized
Randomization description
according to double-blind nature of this trial, from the beginning of the study, A and B codes are available to researchers to recruit the patients using twenty 4-Block Randomization.
Blinding (investigator's opinion)
Double blinded
Blinding description
Only one of the staff of the headache department is aware of the type of assigned intervention for each patient (vitamin D or placebo, which are marked by A or B codes). Finally, after collecting the data, she unseals the codes for researchers, the statistical analyst, and those who prepare the manuscript.
Placebo
Used
Assignment
Parallel
Other design features
The duration of this randomized, double-blind, placebo controlled trial will be 16 weeks, consisting of 4-week of baseline following by 12-week intervention. Also, patients will be instructed to fill out a headache diary designed by our headache specialist neurologist in order to provide headache characteristics including headache severity, duration of attacks, number of attacks, and number of days with headache in the month. Patients will be asked to not change their medications during the study.

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Tehran University of Medical Sciences
Street address
Ghods Street
City
Tehran
Province
Tehran
Postal code
1417653761
Approval date
2018-04-08, 1397/01/19
Ethics committee reference number
IR.TUMS.VCR.REC.1397.094

Health conditions studied

1

Description of health condition studied
migraine headache
ICD-10 code
G43
ICD-10 code description
Migraine

Primary outcomes

1

Description
migraine attack frequency per month
Timepoint
baseline-end of study
Method of measurement
headache diary

2

Description
attack severity
Timepoint
baseline-end of study
Method of measurement
headache diary-visual analogue scale

3

Description
headache attack duration (min per month)
Timepoint
baseline-end of study
Method of measurement
headache diary-visual analogue scale

Secondary outcomes

1

Description
serum 25 (OH) D3
Timepoint
baseline- end of study
Method of measurement
laboratory test

2

Description
serum vitamin D receptor
Timepoint
baseline- end of study
Method of measurement
laboratory test

3

Description
determining inflammatory status (including serum levels of iNOS, IL 6, Cox 2, CGRP, and IL10 )
Timepoint
baseline- end of study
Method of measurement
laboratory test

4

Description
Determining Treg/th17 balance (including serum levels of TGF b and IL-17)
Timepoint
baseline- end of study
Method of measurement
laboratory test

5

Description
serum prolactin levels
Timepoint
baseline- end of study
Method of measurement
laboratory test

Intervention groups

1

Description
Intervention group: intervention group will receive 1 capsule which contains 2000 of vitamin D every day for 12 weeks
Category
Prevention

2

Description
Control group: placebo group will receive 1 capsule of placebo with the same smell and taste as vitamin D during 12-week period.
Category
Prevention

Recruitment centers

1

Recruitment center
Name of recruitment center
Sina University Hospital
Full name of responsible person
Dr Mansoureh Togha
Street address
Imam Khomeini Street
City
Tehran
Province
Tehran
Postal code
1136746911
Phone
+98 21 6312 1506
Email
toghae@sina.tums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Ms Fatemeh Javadi
Street address
Shahid Naderi Street
City
Tehran
Province
Tehran
Postal code
14155-6117
Phone
+98 21 8895 5975
Email
javadi_fateme@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran University of Medical Sciences
Proportion provided by this source
60
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

2

Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Ms Bahare Pourghaz
Street address
Dr Gharib Street
City
Tehran
Province
Tehran
Postal code
1419733141
Phone
+98 21 6690 3066
Email
pourghaz.bahar@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran University of Medical Sciences
Proportion provided by this source
40
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
Tehran University of Medical Sciences
Full name of responsible person
Dr Maryam Mahmoudi
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
No: 44 Hojjat-dost Alley, Naderi St., Keshavarz Blvd, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
14155-6117
Phone
+98 21 8895 5975
Fax
+98 21 8895 5975
Email
m-mahmoudi@sina.tums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Zeinab Ghorbani
Position
PhD candidate in Nutritional sciences
Latest degree
Master
Other areas of specialty/work
Nutrition
Street address
Shahid Naderi Street
City
Tehran
Province
Tehran
Postal code
14155-6117
Phone
+98 21 8895 5975
Email
zghorbani@razi.tums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Zeinab Ghorbani
Position
PhD candidate in Nutritional sciences
Latest degree
Master
Other areas of specialty/work
Nutrition
Street address
Shahid Naderi Street
City
Tehran
Province
Tehran
Postal code
14155-6117
Phone
+98 21 8895 5975
Email
zghorbani@razi.tums.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
Loading...