UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040841 |
|---|---|
| Receipt number | R000046630 |
| Scientific Title | Green tea benefits for thalassemia intermedia |
| Date of disclosure of the study information | 2020/06/21 |
| Last modified on | 2021/06/26 05:15:37 |
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Basic information
Public title
Green tea influence on iron overload in thalassemia intermedia
Acronym
GTIIOTI
Scientific Title
Green tea benefits for thalassemia intermedia
Scientific Title:Acronym
GTBTI
Region
| Asia(except Japan) |
Condition
Condition
Green tea in thalassemia intermedia
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We aimed to estimate iron accumulation levels in TI patients treated with deferasirox after GT intake.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Measuring iron overload through serum ferritin and T2* MRI for LIC
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Open -no one is blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Green tea cap (150 ml) within an hour after each meal three times daily
Interventions/Control_2
Water cup within an hour after each meal three times daily
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 10 | years-old | <= |
Age-upper limit
| 60 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Thalassemia intermedia without complications and chronic disease
Key exclusion criteria
Transfusion dependant thalassemia
Target sample size
141
Research contact person
Name of lead principal investigator
| 1st name | Hayder |
| Middle name | |
| Last name | Al-Momen |
Organization
University of Baghdad
Division name
Al-Kindy College of Medicine
Zip code
00964
Address
Al-Nahda square, Baghdad, Iraq
TEL
009647811284169
hayder77almusawi@gmail.com
Public contact
Name of contact person
| 1st name | Hayder |
| Middle name | |
| Last name | Al-Momen |
Organization
University of Baghdad
Division name
Al-Kindy College of Medicine
Zip code
00964
Address
Al-Nahda square, Baghdad, Iraq
TEL
009647811284169
Homepage URL
hayder77almusawi@gmail.com
Sponsor or person
Institute
University of Baghdad
Institute
Department
Personal name
Funding Source
Organization
University of Baghdad
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
University of Baghdad, Al-Kindy College of Medicine
Address
Al-Nahda square, Baghdad, Iraq
Tel
009647719807372
sarmarsarmar@yahoo.com
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 06 | Month | 21 | Day |
Related information
URL releasing protocol
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7520712/
Publication of results
Published
Result
URL related to results and publications
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7520712/
Number of participants that the trial has enrolled
68
Results
At baseline, both groups were matched regarding general demographics. At 12 months, the net drop of liver iron concentration in the green tea group (7.3 mg Fe/g dry weight) was significantly higher than the control group (4.6 mg Fe/g dry weight) (p<0.05). This was also seen with serum ferritin; net reduction in green tea and control groups were 1289 ng/ml and 871 ng/ml, respectively (p<0.05).
Results date posted
| 2021 | Year | 06 | Month | 26 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2020 | Year | 09 | Month | 25 | Day |
Baseline Characteristics
Using a random selection method, 141 thalassemia intermedia patients were initially screened for inclusion in this trial
Participant flow
Only 68 patients included after applying exclusion criteria. Two equal groups were generated (n=34/group): green tea (three cups/day after meals) + usual treatment (deferasirox iron chelator and on demand blood transfusion); and control (only usual treatment)
Adverse events
None
Outcome measures
Regular green tea consumption had a significant capability to improve iron deposition in thalassemia intermedia patients who already undergo deferesirox iron chelation therapy.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2019 | Year | 01 | Month | 08 | Day |
Date of IRB
| 2020 | Year | 01 | Month | 23 | Day |
Anticipated trial start date
| 2019 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2020 | Year | 02 | Month | 29 | Day |
Date of closure to data entry
| 2020 | Year | 06 | Month | 15 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2020 | Year | 06 | Month | 21 | Day |
Last modified on
| 2021 | Year | 06 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046630
| Research Plan | |
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| Registered date | File name |
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