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Effect of green tea consumption on iron stores, metabolic and oxidative status in beta-thalassemia major patients

Protocol summary

Summary
Objective: Effects of green tea consumption on iron stores, metabolic and oxidative status in beta-thalassemia major. Design: This study is designed as a randomized clinical, not blined and phase 3 trial in patients with thalassemia major who will be referred the Tabriz Ghazi Tabatabaei hospital. Inclusions criteria؛ Including beta-thalassemia disease, usage of chelator drug deferoxamine, not suffering from viral hepatitis B and C, having over 18 years of age and not use of any antioxidant supplements 3 months before intervention. Absence of any of the above conditions will result in withdrawal from the study subjects. 52 patients (sample size) will be divided into 2 groups randomly, intervention and control. Intervention: Intervention groups will receive daily 3 cups of green tea (each cups contain a 2.5 grams of green tea bag in 150 cc boiled water) immediately after the meal for 8 weeks and control group use the same amount of boiled water daily instead of green tea in this period. Outcome: Iron stores levels (Iron serum, Ferritin serum, Transferrin Saturation and TIBC), liver enzymes (AST, ALT), lipid profiles (Total cholesterol, Triglyceride, HDL-C and LDL-C) and indicators of oxidative stress (total antioxidant capacity and malondialdehyde) in both groups before and after the intervention will be measured.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201403303664N10
Registration date: 2014-11-29, 1393/09/08
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2014-11-29, 1393/09/08
Registrant information
Name
Maryam Rafraf
Name of organization / entity
Tabriz University Of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 1335 7580
Email address
rafrafm@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for Research, Tabriz University of Medical Sciences
Expected recruitment start date
2014-11-22, 1393/09/01
Expected recruitment end date
2015-02-20, 1393/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of green tea consumption on iron stores, metabolic and oxidative status in beta-thalassemia major patients
Public title
Effect of green tea consumption in the treatment of patients with beta-thalassemia major
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Beta-thalassemia disease; usage of chelator drug deferoxamine; not suffering from viral hepatitis B and C; having over 18 years of age and not use of any antioxidant supplements 3 months before intervention. Exclusion criteria: Absence of any of the above conditions will result in withdrawal from the study subjects
Age
From 18 years old to 50 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size: 52
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

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Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Tabriz University of Medical Sciences
Street address
Sience Medical of University Tabriz of department Central, Street Azadi, Street Golgasht, Tabriz
City
Tabriz
Postal code
Approval date
2014-05-18, 1393/02/28
Ethics committee reference number
9327

Health conditions studied

1

Description of health condition studied
Beta thalassaemia
ICD-10 code
D56.1
ICD-10 code description
Beta thalassaemia

Primary outcomes

1

Description
Iron stores levels ( Iron serum, Ferritin serum, Transferrin Saturation and TIBC)
Timepoint
Baseline and after 8 weeks of intervention
Method of measurement
Spectrophotometry for Iron serum and TIBC, ELISA assay for ferritin and Iron serum/TIBC* 100 for Transferrin Saturation

2

Description
liver enzymes (AST, ALT)
Timepoint
Baseline and after 8 weeks of intervention
Method of measurement
Spectrophotometry

3

Description
Lipid profiles (TC, TG, LDL-C, HDL-C)
Timepoint
Baseline and after 8 weeks of intervention
Method of measurement
Enzymatic methods for TC,TG and HDL-C For LDL-C : Freidwald’s formula: LDL-C = TC- HDL-C - (TG/5)

4

Description
Serum Total Antioxidant Capacity
Timepoint
Baseline and after 8 weeks of intervention
Method of measurement
Spectrophotometry

5

Description
Serum Malondialdehyde (MDA)
Timepoint
Baseline and after 8 weeks of intervention
Method of measurement
Spectrophotometry

Secondary outcomes

1

Description
Macronutrients intake
Timepoint
Before and after 8 weeks intervention
Method of measurement
24-h Recall Questionnaire

2

Description
Anthropometric index(weight and Body Mass Index)
Timepoint
Before and after 8 weeks intervention
Method of measurement
Analogue scale for weight and weight (Kg) /Square Height for Body Mass Index

Intervention groups

1

Description
Intervention group will receive daily 3 cups of green tea immediately after the meal for 8 weeks (each cup of green tea is produced by putting green tea bag contains 2.5 grams in 150 cc of boiled water). Green tea bags will be purchased from the tea Research Center in North. All the patients will receive the Tea bags on every two weeks base and will be monitored for consumption continuation and any possible adverse effects by telephone interviews.
Category
Treatment - Drugs

2

Description
Control group 3 cups lukewarm boiled water daily over the same period (per cup after meal consumption).
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Tabriz Qazi Tabatabaei hospital
Full name of responsible person
Ehsan Soeizi
Street address
Next to the School of Dentistry, University Ave, Tabriz
City
Tabriz

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research, Tabriz University of Medical Sience
Full name of responsible person
Dr Bahram Pourghasem Gagari
Street address
Tabriz University of Medical Sience, Golgasht Street, Azadi Street, Tabriz
City
Tabriz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Tabriz University of Medical Sience
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Tabriz University of Medical Siences
Full name of responsible person
Ehsan Soeizi
Position
MSc student of nutrition
Other areas of specialty/work
Street address
Sience Medical of University of Tabriz of faculty Nutrition, Golgasht Street, Tabriz
City
Tabriz
Postal code
Phone
+98 41 3656 0683
Fax
Email
Esoeizi@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tabriz University of Medical Siences
Full name of responsible person
Ehsan Soeizi
Position
MSc student of nutrition
Other areas of specialty/work
Street address
Sience Medical of University Tabriz of faculty Nutririn, Golgasht Street, Tabriz
City
Tabriz
Postal code
Phone
+98 41 3656 0638
Fax
Email
Esoeizi@gmail.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Tabriz University of Medical Siences
Full name of responsible person
Ehsan Soeizi
Position
MSc student of nutrition
Other areas of specialty/work
Street address
Sience Medical of University Tabriz of faculty Nutrition, Golgasht street, Tabriz
City
Tabriz
Postal code
Phone
+98 41 3656 0638
Fax
Email
Esoeizi@gmail.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
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Informed Consent Form
empty
Clinical Study Report
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Analytic Code
empty
Data Dictionary
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