Investigating the effect of cinnamon biscuits enriched with vitamin D compared to simple biscuits on the intensity, duration and frequency of migraine attacks and inflammatory indices in people suffering from migraine headaches: a randomized, controlled, double-blind clinical trial
Determining the effect of cinnamon biscuits enriched with vitamin D on the intensity, duration, frequency of migraine attacks and inflammatory indices in people suffering from migraine headaches.
Design
This is a double-blind randomized clinical trial with 2 parallel groups (one intervention and control groups). In present study, 58 people are randomly allocated between two groups (29 people in each group).
Settings and conduct
The current study will be conducted in Emam Reza Clinic (a clinic affiliated to Shiraz University of Medical Sciences) in Shiraz city. Participants in this study are those afflicted with migraine headache. This is a double-blind study that for the blindness, all fortified and simple biscuits are produced similarly according to the appearance (shape and total appearance) and are delivered from the factory with A and B codes in order not to allow the main researcher and the patients become informed of the grouping.
Participants/Inclusion and exclusion criteria
Inclusion criteria: suffering from migraine disease; age >18 years; people with a body mass index less than 30 (not being obese).
Exclusion criteria: sensitivity and allergy to cinnamon; taking any herbal or medicinal supplements effective on migraine; following food regimens; taking vitamin D supplements
Intervention groups
Intervention group: 29 participants will consume 3 cinnamon biscuits enriched with vitamin D (1800 mg of cinnamon and 2000 IU of vitamin D) for 10 weeks.
Control group: 29 participants will consume 3 plain biscuits daily as a snack for 10 weeks.
Main outcome variables
Intensity, duration, and frequency of migraine attacks; inflammatory indicators (nitric oxide and interleukin)
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20240212060963N1
Registration date:2024-04-17, 1403/01/29
Registration timing:prospective
Last update:2024-04-17, 1403/01/29
Update count:0
Registration date
2024-04-17, 1403/01/29
Registrant information
Name
Donya Arjmandfard
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 3632 5297
Email address
donya.arjmand9777@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-05-10, 1403/02/21
Expected recruitment end date
2024-08-22, 1403/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of cinnamon biscuits enriched with vitamin D compared to simple biscuits on the intensity, duration and frequency of migraine attacks and inflammatory indices in people suffering from migraine headaches: a randomized, controlled, double-blind clinical trial
Public title
Effect of cinnamon biscuits enriched with vitamin D on migraine headaches
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Willingness to cooperate in research
suffering from migraine disease with a definite doctor's diagnosis
Age above 18 years
People with a body mass index less than 30 (not being obese)
Exclusion criteria:
Allergy and sensitivity to cinnamon
Suffering from infectious diseases in the past month
Taking antibiotics in the past month
Being hospitalized in the past month
Taking any herbal or medicinal supplements effective on migraine
Taking excessive headache tranquilizer
Following special food regimens
Having diabetes (due to the need to consume biscuits during the study period)
Taking vitamin D supplements
Being pregnant
Breastfeeding
Age
From 18 years old
Gender
Both
Phase
1-2
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
58
Randomization (investigator's opinion)
Randomized
Randomization description
Patients will be randomly assigned in a 1:1 ratio into two groups: Blocked randomization with a fixed block size of four will be performed by one of the investigators who has no clinical involvement in the study using Random Allocation Software. The person outside our study gives the sealed envelopes to the people, who determines whether the person is in the intervention or control group.
Blinding (investigator's opinion)
Double blinded
Blinding description
For blinding of the intervention, enriched biscuits and placebo ones will be prepared similarly considering the appearance (shape and general appearance) and they will be delivered from the factory with the codes A and B so that the researcher and patient are not aware of the grouping and blindness is respected.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Shiraz University of Medical Sciences
Street address
School of Nutrition and Food Sciences; Razi boulevard; Shiraz
City
Shiraz
Province
Fars
Postal code
7134814336
Approval date
2024-03-16, 1402/12/26
Ethics committee reference number
IR.SUMS.REC.1402.604
Health conditions studied
1
Description of health condition studied
Migraine headache
ICD-10 code
G43.1
ICD-10 code description
Migraine with aura
Primary outcomes
1
Description
Frequency of headache attacks
Timepoint
At the beginning of the study (before the start of the intervention) and at the end of the study (10 weeks after the start of the intervention)
Method of measurement
Interview with patients
2
Description
Duration of headache
Timepoint
At the beginning of the study (before the start of the intervention) and at the end of the study (10 weeks after the start of the intervention)
Method of measurement
Interview with patients
3
Description
Migraine headache intensity
Timepoint
At the beginning of the study (before the start of the intervention) and at the end of the study (10 weeks after the start of the intervention)
Method of measurement
Based on Visual Analogue Scale (VAS)
4
Description
Interleukin-6 level
Timepoint
At the beginning of the study (before the start of the intervention) and at the end of the study (10 weeks after the start of the intervention)
Method of measurement
ELISA Kit
5
Description
Nitric oxide (NO) level
Timepoint
At the beginning of the study (before the start of the intervention) and at the end of the study (10 weeks after the start of the intervention)
Method of measurement
ELISA Kit
Secondary outcomes
1
Description
Sleep quality score
Timepoint
At the beginning of the study (before the start of the intervention) and at the end of the study (10 weeks after the start of the intervention)
Method of measurement
Questionnaire
Intervention groups
1
Description
Intervention group: They receive 3 cinnamon biscuits enriched with vitamin D (contains 1800 mg of cinnamon and 2000 IU of vitamin D) as a snack daily for 10 weeks.
Category
Treatment - Other
2
Description
Control group: They receive 3 simple biscuits as a snack daily for 10 weeks.