Comparison of the effect of green tea and black tea on the iron overload in patients with thalassemia major
Design
Randomized controlled clinical trial with two intervention groups, parallel groups, without blinding, phase 4 on 75 patients, randomized using table of random numbers.
Settings and conduct
This clinical trial study was performed on 75 patients with thalassemia major treated with blood transfusion in Zabol city who had the criteria to enter the study. Samples were randomly divided into three groups. First, patients' serum ferritin levels were measured. Intermediate consumption of green or black tea, 2 grams of tea provided by the researcher, three times a day, after each main meal was performed for one month, and patients' serum ferritin levels were measured again after the intervention.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Age between 8 and 20 years; Frequent blood transfusions; Ferrtin serum levels above 1000 ng / dL. Exclusion criteria: sensitivity to tea; diseases such as stomach ulcers that are exacerbated by tea consumption.
Intervention groups
The intervention was performed in two groups. Intervention group 1: green tea. Intervention group 2: black tea. In both groups 2 grams of tea was given for 1 month on a daily basis after each meal. No intervention was made in the control group.
Main outcome variables
Iron overload depletion; iron accumulation in different parts of the body
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200606047670N1
Registration date:2020-07-06, 1399/04/16
Registration timing:retrospective
Last update:2020-07-06, 1399/04/16
Update count:0
Registration date
2020-07-06, 1399/04/16
Registrant information
Name
sadegh dehghanmehr
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 54 3344 2481
Email address
sa.dehghanmehr@zaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-06-10, 1396/03/20
Expected recruitment end date
2017-07-23, 1396/05/01
Actual recruitment start date
2017-06-10, 1396/03/20
Actual recruitment end date
2017-07-23, 1396/05/01
Trial completion date
2018-01-02, 1396/10/12
Scientific title
Comparative study of the effect of Green tea and black tea on the Iron overload in patients with thalassemia major
Public title
Comparative study of the effect of Green tea and black tea on the Iron overload in patients with thalassemia major
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Having thalassemia major and 2 blood transfusions per month for treatment
not suffering from metabolic diseases and cancer
willingness to participate in the study
serum ferritin level above 1000 micrograms per liter
Exclusion criteria:
Eat foods rich in polyphenols such as chocolate and coffee over the past week
Allergies and allergies to a variety of teas
Illnesses such as stomach ulcers that can be exacerbated by tea consumption
Age
From 8 years old to 20 years old
Gender
Both
Phase
4
Groups that have been masked
No information
Sample size
Target sample size:
75
Actual sample size reached:
75
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization Method: Simple Randomization, Randomization Unit: Individual and Instrumental Random Tools: Using Lottery.Write from 1 to 75 on small pieces of paper and put them in a bag, and each research unit takes a piece of paper at random without reading the written number. Then patients 1 to 25 were in the intervention group 1, patients from the 26th to the 50th intervention 2 and the rest up to 75 were in the control group.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Zabol University of Medical Sciences
Street address
Health Crossroads
City
Zabol
Province
Sistan-va-Balouchestan
Postal code
9861844863
Approval date
2017-05-22, 1396/03/01
Ethics committee reference number
IR.ZBMU.REC.1396.68
Health conditions studied
1
Description of health condition studied
thalassemia major
ICD-10 code
D56.1
ICD-10 code description
Beta thalassemia
Primary outcomes
1
Description
Serum ferritin levels more than 1000 ng / dL
Timepoint
Measurement of serum ferritin at the beginning of the study and 30 days after tea consumption
Method of measurement
Eliza Method and Tecan a-55-82 machin
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: First intervention: Green tea was consumed 2 grams daily after each meal for 1 month, prepared and packed by the researcher from reputable stores.
Category
Treatment - Other
2
Description
Intervention group: Intervention 2: black tea 2 grams per day after each meal for 1 month prepared and packed by the researcher from reputable stores.
Category
Treatment - Other
3
Description
Control group: No intervention was performed for the control group, and patients received their routine treatment as usual.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Khomeini Hospital, Special Diseases Center
Full name of responsible person
Dr. Mirzaie
Street address
Hospital Crossroads
City
Zabol
Province
Sistan-va-Balouchestan
Postal code
98618-44863
Phone
+98 54 3222 6069
Email
sadeghmehr3405@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Zabol University of Medical Sciences
Full name of responsible person
Dr.Rezaei
Street address
Health Quarters
City
Zabol
Province
Sistan-va-Balouchestan
Postal code
9861844862
Phone
+98 54 3223 5299
Email
safora3405@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Zabol 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
Zahedan University of Medical Sciences
Full name of responsible person
Sadegh Dehghanmehr
Position
Lecturer
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Celebrity Square
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9818686653
Phone
+98 54 3344 2481
Email
sadeghdehghan3407@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Sadegh Dehghanmehr
Position
Lecturer
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Celebrity Square
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9818686653
Phone
+98 54 3344 2481
Email
sadeghdehghan3407@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Sadegh Dehghanmehr
Position
Lecturer
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Celebrity Square
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9818686653
Phone
0098 54 332481
Email
sadeghdehghan3407@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
There is no further information.
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not 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
To help reduce the iron Overload and its side effects in patients, and for other researchers to use this study for future studies.
When the data will become available and for how long
After printing the information in the articles
To whom data/document is available
Interested in all people including researchers, patients and others
Under which criteria data/document could be used
For new studies - if the data is not used exactly.
From where data/document is obtainable
To sadeghdehghan3407@gmail.com
What processes are involved for a request to access data/document
The reason for using the documents and how to conduct the study should be clearly stated in the application.