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Comparing Green Tea and Placebo on Blood iron indices, Sputum Smear Conversion and Expression of Hepcidin and Transferrin receptor Genes in Smear Positive TB Patients

Protocol summary

Summary
This study aims to determine the effects of green tea on the treatment course of smear positive tuberculosis patients. Inclusion criteria include: age older than 16 years with definitive TB diagnosis, not affecting by hepatitis or diabetes mellitus type 1, and exclusion criteria include: severe changes in liver function tests, any autoimmune diseases and allergy to green tea. After acquiring sufficient information and signing informed consent, 88 patients with smear positive TB in the Golestan province will be randomly assigned to intervention and control groups in a double-blinded manner. Besides treatment with antibiotics, the intervention group will receive supplementation with daily green tea capsules contains 400 mg catechins and control group with placebo for 2 months. Demographic data, Food Frequency Questionnaires and anthropometric measurements will perform for patients before and after intervention. Clinical examination at baseline study and follow-up visits (1st & 2nd month) will be done. Food recall will be completed in the 3 inconsecutive days each month. Hemoglobin, TIBC, Ferritin, Transferrin, serum iron, serum malondialdehyde measurement will be done before and after intervention. From third to the ninth weeks every 10 days sputum smear samples will be examined for bacterial load. Cellular mRNA using standard protocol will be purified from biological samples and Transferrin receptor and Hepcidin expression at the transcriptional level will be measured semi-quantitatively. Comparing two groups before and after, statistical analysis will be performed.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201212232602N11
Registration date: 2013-04-07, 1392/01/18
Registration timing: prospective

Last update:
Update count: 0
Registration date
2013-04-07, 1392/01/18
Registrant information
Name
Shahryar Eghtesadi
Name of organization / entity
Iran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8877 9118
Email address
egtesadi@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Research Council of Golestan University of Medical Sciences Research Council of Tehran University of Medical Sciences
Expected recruitment start date
2013-04-21, 1392/02/01
Expected recruitment end date
2013-10-21, 1392/07/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing Green Tea and Placebo on Blood iron indices, Sputum Smear Conversion and Expression of Hepcidin and Transferrin receptor Genes in Smear Positive TB Patients
Public title
Clinical and laboratory study on the effects of green tea on the treatment of patients with Smear positive TB
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: Definitive diagnosis of TB according to Ministry of Health criteria; Location in Golestan Province ; treatment of patients under DOTS strategy; Age 15 years and over; Willingness to cooperate in study Exclusion criteria : Allergic symptoms or side effects of green tea consumption; Severe changes in liver function tests due to anti-TB drugs; Side-effects of anti-TB drugs
Age
From 16 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 88
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Golestan University of Medical Sciences, Deputy of Research and Technology
Street address
Shast Cola Road, Falsafi Estate
City
Gorgan
Postal code
4934174515
Approval date
2012-09-02, 1391/06/12
Ethics committee reference number
G P/ 132414/35

Health conditions studied

1

Description of health condition studied
Respiratory Tuberculosis
ICD-10 code
A15.0
ICD-10 code description
Tuberculosis of lung, confirmed by sputum microscopy with or without culture

Primary outcomes

1

Description
sputum smear conversion
Timepoint
from day 20 to 60 every 10 days
Method of measurement
microscopic smear of sputum

Secondary outcomes

1

Description
Hemoglobin
Timepoint
begining of treatment and end of second month
Method of measurement
laboratory measurement

2

Description
Transferrin receptor gene expression
Timepoint
begining of treatment and end of second month
Method of measurement
real time PCR

3

Description
Hepcidin gene expression
Timepoint
begining of treatment and end of second month
Method of measurement
real time PCR

4

Description
TIBC
Timepoint
begining of treatment and end of second month
Method of measurement
laboratory measurement

5

Description
Transferrin
Timepoint
begining of treatment and end of second month
Method of measurement
laboratory measurement

6

Description
Ferritin
Timepoint
begining of treatment and end of second month
Method of measurement
laboratory measurement

Intervention groups

1

Description
The control group will receive placebo capsules for two months daily beside the anti-tuberculosis therapy.
Category
Other

2

Description
The intervention group will receive green tea capsules 400 mg daily beside the anti-tuberculosis therapy.
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Golestan Province Health Center
Full name of responsible person
Mohammad Reza Honarvar
Street address
Glolestan Medical University, Research Council, Shast Cola Road
City
Gorgan

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Research Council of Golestan University of Medical Sciences
Full name of responsible person
Mohammad Jafar Golalipoor
Street address
Gorgan Golestan Medical University shast cola
City
Gorgan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Research Council of Golestan 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
Golestan University of Medical Sciences
Full name of responsible person
Mohammad Reza Honarvar
Position
PhD student
Other areas of specialty/work
Street address
Glolestan Medical University, Research Council, Shast Cola Road.
City
Gorgan
Postal code
493417515
Phone
+98 17 1442 0199
Fax
+98 17 1442 2658
Email
honarvar@goums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Shahryar Eqtesadi
Position
PhD
Other areas of specialty/work
Street address
Health Colllege of Tehran University, Alvand Street , Argentina square
City
Tehran
Postal code
Phone
+98 21 8877 9487
Fax
Email
egtesadi@iums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Golestan University of Medical Sciences
Full name of responsible person
Mohammad Reza Honarvar
Position
PhD Student
Other areas of specialty/work
Street address
Shast Cola Road, Research Council, Glolestan Medical University.
City
Gorgan
Postal code
493417515
Phone
+98 17 1442 0199
Fax
+98 17 1442 2658
Email
honarvar@goums.ac.ir
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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