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The effect of oral quercetin supplement intake on oxidative markers , serum iron, liver enzymes and inflammatory indices in β-thalassemia major patients,a double-blind placebo-controlled clinical trial

Protocol summary

Summary
The aim of this study is to determine the effect of oral quercetin supplement intake on oxidative markers , serum iron, liver enzymes and inflammatory indices in β-thalassemia major patients. 84 beta thalassemia major patieents, 18 to 30 years old with serume ferritin level between 2500 to 3500 ng/ml and iron chelation therapy with desferrioxamine will be enrolled and allocated double-blinded and 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. There will be two blood specimen collection before and after the intervention to measure Malondialdehyde (MDA), Super Oxide Dismutase (SOD) and Glutathione peroxidase (GPx), total antioxidant capacity (TAC) as the primary outcomes and serum iron, ferritin, transferrin, total iron binding capacity (TIBC), transferrin saturation (TS), Alanine transaminase (ALT), Aspartate transaminase (AST), Alkaline phosphatase (ALP), high-sensitivity C-reactive protein (hs-CRP) and tumor necrosis factor (TNF) as the secondry outcomes.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201701172709N43
Registration date: 2017-04-13, 1396/01/24
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2017-04-13, 1396/01/24
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
Vice Chancellor for research, Iran University of Medical Siences
Expected recruitment start date
2017-03-21, 1396/01/01
Expected recruitment end date
2017-07-21, 1396/04/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of oral quercetin supplement intake on oxidative markers , serum iron, liver enzymes and inflammatory indices in β-thalassemia major patients,a double-blind placebo-controlled clinical trial
Public title
Quercetin in thalassemia
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: 18 to 30 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; Serum ferritin level between 2500 to 3500 ng/ml 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; Splenectomy; 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 30 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size: 84
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
The method of "permuted block randomization" will be used for the randomization.

Secondary Ids

1

Registry name
Secondary trial Id
Registration date
2017-11-21, 1396/08/30

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Iran University of Medical Sciences
Street address
before the Chamran intersection, East Hemmat highway,Tehran
City
Tehran
Postal code
Approval date
2017-01-16, 1395/10/27
Ethics committee reference number
IR.IUMS.REC 1395.9411323006

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
malone dialdehyde (MDA)
Timepoint
before and after the intervention
Method of measurement
nmol/gHb, colorimetry

2

Description
total antioxidant capacity (TAC)
Timepoint
before and after the intervention
Method of measurement
mmol/L, colorimetry

3

Description
Superoxide dismutase (SOD)
Timepoint
before and after the intervention
Method of measurement
U/gHb, colorimetry

4

Description
Glutathione peroxidase (GPx)
Timepoint
before and after the intervention
Method of measurement
U/gHb, colorimetry

Secondary outcomes

1

Description
serum Fe
Timepoint
before and after the intervention
Method of measurement
spectrophotometry,µg/dl

2

Description
serum transferrin
Timepoint
before and after the intervention
Method of measurement
immunoturbidometry, mg/dl

3

Description
serum ferritin
Timepoint
before and after the intervention
Method of measurement
spectrophotometry, ng/ml

4

Description
total antioxidant capacity (TIBC)
Timepoint
before and after the intervention
Method of measurement
calorimetry, µg/dl

5

Description
transferrin saturation
Timepoint
before and after the intervention
Method of measurement
formula, %

6

Description
Aspartate transaminase (AST)
Timepoint
before and after the intervention
Method of measurement
enzymatic calorimetry, IU/L

7

Description
Alanin transaminase (ALT)
Timepoint
before and after the intervention
Method of measurement
enzymatic calorimetry, IU/L

8

Description
Alkaline phosphatase (ALP)
Timepoint
before and after the intervention
Method of measurement
enzymatic calorimetry, IU/L

9

Description
high-sensitivity C reactive protein (hs-CRP)
Timepoint
before and after the intervention
Method of measurement
ELISA, µg/ml

10

Description
tumor necrosis factor alpha (TNF)
Timepoint
before and after the intervention
Method of measurement
Elisa, pg/ml

Intervention groups

1

Description
quercetin,90 tablets,500mg,3 months, once a day after a meal
Category
Treatment - Drugs

2

Description
starch placebo, 90 tablets,500 mg, 3 months, once a day after a meal
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Adult Thalassemia Clinic
Full name of responsible person
Street address
Ladan square, Zafar avenue, Tehran
City
Tehran

2

Recruitment center
Name of recruitment center
Iran Thalassemia Community
Full name of responsible person
Street address
Number 22, Keshavarz Boulevard, Valiasr avenue, Tehran
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research, Iran University of Medical Sciences
Full name of responsible person
Dr. Morteza Naser Bakht
Street address
before the Chamran intersection, East Hemmat highway,Tehran
City
Tehran
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, Iran University of Medical Sciences
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
High Institute for Research and Education in Transfusion Medicine
Full name of responsible person
Dr. Azita Azarkeivan
Position
Pediatric Hematology Oncology
Other areas of specialty/work
Street address
before the Chamran intersection, East Hemmat highway,Tehran
City
Tehran
Postal code
Phone
+98 22920088
Fax
Email
azazarkeivan@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Dr. Farzad Shidfar
Position
PHD of Nutrition Sciences
Other areas of specialty/work
Street address
before the Chamran intersection, East Hemmat highway,Tehran
City
Tehran
Postal code
Phone
+98 88607945
Fax
Email
Farzadshidfar@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Zohreh Sajady Hezaveh
Position
M.Sc. student of Health in Nutrition
Other areas of specialty/work
Street address
before the Chamran intersection, East Hemmat highway,Tehran
City
Tehran
Postal code
Phone
Fax
Email
zohre_sjd@yahoo.com
Web page address

Sharing plan

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