Determination and comparison of mood score based on the Beck questionnaire between the Quercetin group and the placebo at the end of the intervention and within each group before and after the intervention
Design
In this research, 84 eligible patients referring to Zafar Thalassemia Clinic were chosen purposefully and a code was allocated to each one of them. Then, patients were randomly divided into two control and intervention groups.
Settings and conduct
This clinical trial will be held in Zafar thalassemia clinic. 84 eligible patients will be chosen and allocated randomly to the quercetin or the placebo group. The quercetin group will recieve a 500 mg quercetin tablet each day and the placebo group will recieve a 500 mg starch tablet each day for 3 months this is a double blind trial and neither the researcher nor the patients will be aware of the supplement being placebo or quercetin. once before and once after the intervention Beck's questionnaire will be filled to determine mood changes.
Participants/Inclusion and exclusion criteria
84 beta thalassemia major patients will be enrolled in this study.
Inclusion criteria: 18 to 40 year old male and female beta thalassemia major patients
Inclination to cooperate and signing the written informed consent
A minimum of 2 years of blood transfusion history
blood specimen collection 20 days after the last blood transfusion
Regular and peculiar iron-chelating therapy with desferrioxamine
Vitamin C supplement intake with desferrioxamine
Exclusion criteria: A change in type or amount of the iron chelator
Pregnancy or lactation
Hepatitis infection and other metabolic or infectious diseases
Less than 80% compliance of supplement intake
Consumption of drugs that interfere with quercetin
Drinking more than 500 mg/day of beverages rich in flavonoids
Smoking or alcohol consumption
Intervention groups
There will be two interventional groups: 42 patients in the quercetin group will recieve a 500 mg quercetin tablet each day and 42 patients in the placebo group will recieve a 500 mg starch tablet each day for 3 months
Main outcome variables
mood changes
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20091114002709N46
Registration date:2018-02-11, 1396/11/22
Registration timing:retrospective
Last update:2018-02-11, 1396/11/22
Update count:0
Registration date
2018-02-11, 1396/11/22
Registrant information
Name
Farzad Shidfar
Name of organization / entity
Iran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8862 2755
Email address
shidfar.f@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-04-22, 1396/02/02
Expected recruitment end date
2017-10-24, 1396/08/02
Actual recruitment start date
2017-04-22, 1396/02/02
Actual recruitment end date
2017-12-13, 1396/09/22
Trial completion date
empty
Scientific title
Study of the effect of oral quercetin supplement intake on mood in β-thalassemia major patients
Public title
Quercetin on thalassemia induced depression
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
18 to 40 year old male and female beta thalassemia major patients
Inclination to cooperate and signing the written informed consent
A minimum of 2 years of blood transfusion history
blood specimen collection 20 days after the last blood transfusion
Regular and peculiar iron-chelating therapy with desferrioxamine
Vitamin C supplement intake with desferrioxamine
Exclusion criteria:
Uncontrollable and life threatening complication due to due to the supplement intake;; ; ; ; ; ;
A change in type or amount of the iron chelator
Pregnancy or lactation
Hepatitis infection and other metabolic or infectious diseases
Less than 80% compliance of supplement intake
Consumption of drugs that interfere with quercetin
Drinking more than 500 mg/day of beverages rich in flavonoids
Smoking or alcohol consumption
Age
From 18 years old to 40 years old
Gender
Both
Phase
2-3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
84
Actual sample size reached:
84
Randomization (investigator's opinion)
Randomized
Randomization description
The method of "permuted block randomization" will be used for the randomization.
Blinding (investigator's opinion)
Double blinded
Blinding description
the researcher, participants, practitioner, and the statistical analyzer were all blinded in this study, which means non of them were aware of the supplement given to and consumed by patients were Quercetin or placebo.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Iran University of Medical Sciences
Street address
After the Chamran Intersection, East Hemmat Highway
City
Tehran
Province
Tehran
Postal code
88654
Approval date
2017-01-20, 1395/11/01
Ethics committee reference number
IR.IUMS.REC 1395.95-04-207-30254
Health conditions studied
1
Description of health condition studied
beta thalassemia major
ICD-10 code
D56.1
ICD-10 code description
Cooley anaemia Severe beta thalassaemia Thalassaemia: intermedia major
Primary outcomes
1
Description
depression
Timepoint
before and after the intervention
Method of measurement
Beck's questionnaire
Secondary outcomes
1
Description
high-sensitivity C-reactive protein(hs-CRP)
Timepoint
before and after the intervention
Method of measurement
using ELISA kit in Microgram/milliliter(micg/ml)
2
Description
Tumor necrosis factor α(TNF-α)
Timepoint
before and after the intervention
Method of measurement
using ELISA kit in Picrogram/milliliter(pg/ml)
Intervention groups
1
Description
Intervention group: a group of 42 thalassemia patients recieved quercetin tablets.They consumed one tablet containing 500 mg quercetin after lunch every day for 3 months and they were given information on possible side effects.
Category
Treatment - Drugs
2
Description
Control group: a group of 42 thalassemia patients recieved placebo tablets.They consumed one tablet containing 500 mg starch, cellulose, etc. after lunch every day for 3 months and they were given information on possible side effects.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
zafar thalassemia clinic
Full name of responsible person
Dr. Amirhossein Tarvand
Street address
Ladan square, Zafar avenue, Tehran
City
Tehran
Province
Tehran
Postal code
19541
Phone
+98 21 2292 0088
Email
info@tehranbtc.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Dr. Seyed Kazem Malakooti
Street address
before the Chamran intersection, East Hemmat highway
City
Tehran
Province
Tehran
Postal code
۱۴۴۹۶۱۴۵۳۵
Phone
+98 21 86701
Email
adminsite@iums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran 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
Blood Transfusion Education & Research Institute.
Full name of responsible person
Dr Azita Azarkeivan
Position
Children's Hematology and Oncology
Latest degree
Subspecialist
Other areas of specialty/work
Thalassemia
Street address
before Chamran intersection, East Hemmat Highway
City
Tehran
Province
Tehran
Postal code
2155888
Phone
+98 21 8800 9222
Email
azazarkeivan@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Dr Farzad Shidfar
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
before the Chamran Intersection, East Hemmat Highway
City
Tehran
Province
Tehran
Postal code
866974
Phone
+98 21 8670 4711
Email
farzadshidfar@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Zohreh Sajadi Hezaveh
Position
M.Sc. Student
Latest degree
Bachelor
Other areas of specialty/work
Nutrition
Street address
before the Chamran Intersection, East Hemmat Highway
City
Tehran
Province
Tehran
Postal code
88564
Phone
+98 21 8860 7945
Email
zohre_sjd@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
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
after making the participants unrecognizable, some personal data like age, marrital status, etc. will be shared to control the confounders.
When the data will become available and for how long
the access period starts a year after printing the results
To whom data/document is available
Researchers and students who need the data for their research projects.
Under which criteria data/document could be used
The use of this study's data is subject to the permission of all project partners. All statistical analyses can be implemented on the data.
From where data/document is obtainable
Dr Farzad Shidfar, School of Paramedical Sciences, Iran university of Medical Sciences
What processes are involved for a request to access data/document
If Dr. Shidfar permits, In less thana month, this study's data will be sent to the requestor in a SPSS file via email.