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The effects of zinc gluconate supplementation on several genes expression, the serum level of inflammatory factors, quality of life, and disease activity in patients with Behcet syndrome: double-blind randomized controlled clinical trial

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History
# Registration date Revision Id
3 2022-06-22, 1401/04/01 234890
2 2021-03-18, 1399/12/28 186212
1 2020-08-02, 1399/05/12 145563
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  • Protocol summary

    Determining the effects of zinc gluconate supplementation on the TLR2 and TLR4 expression, the serum level of TNF-α, quality of life, and disease activity in patients with Behcet syndrome
    To determine the effects of zinc gluconate supplementation on several genes expression, serum level of inflammatory factors, quality of life, and disease activity in patients with Behcet syndrome
    تعیین تاثیر مکمل یاری گلوکونات روی بر بیان TLR2 و TLR4، سطح سرمی TNF-α ، کیفیت زندگی و فعالیت بیماری در بیماران مبتلا به سندرم بهجت
    تعیین تاثیر مکمل یاری گلوکونات روی بر بیان ژن های مختلف، سطح سرمی فاکتورهای التهابی، کیفیت زندگی و فعالیت بیماری در بیماران مبتلا به سندرم بهجت
    Expression of TLR2 and TLR4 genes; Protein expression of TLR2 and TLR4; Serum level of TNF-α; Serum level of zinc; Quality of life and disease activity
    Inflammatory and antioxidant parameters, quality of life and disease activity
    بیان ژن TLR2 و TLR4، بیان پروتئین های TLR2 و TLR4، سطح سرمی TNFα ، سطح سرمی روی، کیفیت زندگی و فعالیت بیماری
    پارامترهای التهابی و آنتی اکسیدانی، کیفیت زندگی و فعالیت بیماری

  • General information

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    52
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    2020-09-01, 1399/06/11
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    2020-11-18, 1399/08/28
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    2021-02-16, 1399/11/28
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    To add some new parameters to the project
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    جهت افزودن برخی پارامترهای جدید به پروژه حاضر
    The effects of zinc gluconate supplementation on the TLR2 and TLR4 genes expression, the serum level of TNF-α, quality of life, and disease activity in patients with Behcet syndrome: double-blind randomized controlled clinical trial
    The effects of zinc gluconate supplementation on several genes expression, the serum level of inflammatory factors, quality of life, and disease activity in patients with Behcet syndrome: double-blind randomized controlled clinical trial
    تاثیر مکمل یاری گلوکونات روی بر بیان ژن های TLR2 و TLR4، سطح سرمی TNFα، کیفیت زندگی و فعالیت بیماری در بیماران مبتلا به سندرم بهجت: کارآزمایی بالینی تصادفی کنترل دار دوسوکور
    تاثیر مکمل یاری گلوکونات روی بر بیان ژن های مختلف، سطح سرمی فاکتورهای التهابی، کیفیت زندگی و فعالیت بیماری در بیماران مبتلا به سندرم بهجت: کارآزمایی بالینی تصادفی کنترل دار دوسوکور

  • Ethics committees

    #1
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    2021-04-12, 1400/01/23
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    IR.TBZMED.REC.1400.070

  • Primary outcomes

    #1
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    NLRP3 gene expression
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    بیان ژن NLRP3
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    Before and the end of the intervention (twelfth week)
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    قبل از مداخله و بعد از اتمام مداخله (هفته دوازدهم)
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    Real time PCR
    empty
    Real time PCR
    #2
    empty
    Caspase-1 gene expression
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    بیان ژن Caspase-1
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    Before and the end of the intervention (twelfth week)
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    قبل از مداخله و بعد از اتمام مداخله (هفته دوازدهم)
    empty
    Real time PCR
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    Real time PCR
    #3
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    Serum level of interleukin-1 beta
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    سطح سرمی اینترلوکین- 1 بتا
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    Before and the end of the intervention (twelfth week)
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    قبل از مداخله و بعد از اتمام مداخله (هفته دوازدهم)
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    ELISA
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    الایزا
    #4
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    Serum level of malondialdehyde
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    سطح سرمی مالون دی آلدئید
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    Before and the end of the intervention (twelfth week)
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    قبل از مداخله و بعد از اتمام مداخله (هفته دوازدهم)
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    ELISA
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    الایزا
    #5
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    Serum level of C-reactive protein
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    سطح سرمی پروتئین واکنشی C
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    Before and the end of the intervention (twelfth week)
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    قبل از مداخله و بعد از اتمام مداخله (هفته دوازدهم)
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    ELISA
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    الایزا

Protocol summary

Study aim
To determine the effects of zinc gluconate supplementation on several genes expression, serum level of inflammatory factors, quality of life, and disease activity in patients with Behcet syndrome
Design
Double-blind randomized controlled clinical trial (RCT) with parallel design in phase 2-3 on 52 patients with Behcet's syndrome. The STATA software will be used for randomization using ralloc command
Settings and conduct
A double-blind (participants and researchers) RCT will be performed on 52 Behcet's syndrome patients referred to the Rheumatology Clinic of Tabriz University of Medical Sciences. After random allocation, the intervention group will receive 1 tablet of zinc gluconate (30 mg of elemental zinc) daily and the control group will receive similar placebo for 12 weeks. For blinding, coding of containers is performed by a third person. At the beginning and end of the intervention, 5 cc of fasting blood samples will be collected and international questionnaire of physical activity, quality of life, disease activity and 3-day food record will be completed
Participants/Inclusion and exclusion criteria
Participants: 52 people with Behcet's syndrome of both genders. Inclusion criteria: Aged 18 to 50 years, ability to give informed consent Exclusion criteria: Intake of supplements less than 70%, change in the dosage and type of medication received during the study, pregnancy, lactation, history of chronic diseases and consumption of nutritional supplements during one month prior to the study
Intervention groups
The intervention group will receive 1 daily tablet of 30 mg elemental zinc (231 mg zinc gluconate tablet) and the control group will receive similar placebo (cornstarch, and microcrystalline cellulose) for 12 weeks
Main outcome variables
Inflammatory and antioxidant parameters, quality of life and disease activity

General information

Reason for update
To add some new parameters to the project
Acronym
IRCT registration information
IRCT registration number: IRCT20100606004105N30
Registration date: 2020-08-02, 1399/05/12
Registration timing: prospective

Last update: 2021-06-12, 1400/03/22
Update count: 2
Registration date
2020-08-02, 1399/05/12
Registrant information
Name
Beit Allah Alipour
Name of organization / entity
Health & Nutrition Faculty
Country
Iran (Islamic Republic of)
Phone
+98 41 1335 7580
Email address
alipourb@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-08-22, 1399/06/01
Expected recruitment end date
2020-11-21, 1399/09/01
Actual recruitment start date
2020-09-01, 1399/06/11
Actual recruitment end date
2020-11-18, 1399/08/28
Trial completion date
2021-02-16, 1399/11/28
Scientific title
The effects of zinc gluconate supplementation on several genes expression, the serum level of inflammatory factors, quality of life, and disease activity in patients with Behcet syndrome: double-blind randomized controlled clinical trial
Public title
Effect of zinc in treatment of Behcet syndrome
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Age range 18 to 50 years (premenopausal woman) Diagnosis of Behcet's disease by a rheumatologist according to IBCD (The International Criteria for Behcet’s Disease) which vascular, eyes, and joints complications indicate the severity of the disease Patients who want to participate in the study
Exclusion criteria:
Pregnancy and lactation History of diabetes and other chronic diseases History of other autoimmune diseases Taking nutritional supplements and antioxidants and alpha lipoic acid during the month before the study
Age
From 18 years old to 50 years old
Gender
Both
Phase
2-3
Groups that have been masked
  • Participant
  • Care provider
  • Investigator
  • Outcome assessor
Sample size
Target sample size: 52
Actual sample size reached: 52
Randomization (investigator's opinion)
Randomized
Randomization description
After reaching the inclusion criteria, individuals will be randomly divided into two groups of intervention and placebo by blocking method. Blocking will be performed based on gender and age and whereby the two groups will be matched in terms of age and gender. The four blocks will be created by STATA statistical software using ralloc command, which will be identified by the letters A, B, C, D. The assigned group is not known before the individual assignment.
Blinding (investigator's opinion)
Double blinded
Blinding description
All tablets (zinc and placebo) in the same shape and color are placed and labeled in the containers by a third person, and two codes are given to individuals, and the codes will be unknown to the researcher until the end of the study.
Placebo
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
Tabriz University of Medical Sciences, Golgasht street
City
Tabriz
Province
East Azarbaijan
Postal code
5165687386
Approval date
2020-06-29, 1399/04/09
Ethics committee reference number
IR.TBZMED.REC.1399.356

2

Ethics committee
Name of ethics committee
Ethics committee of Tabriz University of Medical Sciences
Street address
Tabriz University of Medical Sciences, Golgasht street
City
Tabriz
Province
East Azarbaijan
Postal code
5165687386
Approval date
2021-04-12, 1400/01/23
Ethics committee reference number
IR.TBZMED.REC.1400.070

Health conditions studied

1

Description of health condition studied
Behcet Syndrome
ICD-10 code
M35.2
ICD-10 code description
Behcet's disease

Primary outcomes

1

Description
Toll-like Receptor-2 gene expression
Timepoint
Before and the end of the intervention (twelfth week)
Method of measurement
Real time PCR

2

Description
Toll-like Receptor-4 gene expression
Timepoint
Before and the end of the intervention (twelfth week)
Method of measurement
Real time PCR

3

Description
Toll-like Receptor-2 protein expression
Timepoint
Before and the end of the intervention (twelfth week)
Method of measurement
Flow cytometry

4

Description
Toll-like Receptor-4 protein expression
Timepoint
Before and the end of the intervention (twelfth week)
Method of measurement
Flow cytometry

5

Description
Serum level of tumor necrosis factor-alpha
Timepoint
Before and the end of the intervention (twelfth week)
Method of measurement
ELISA

6

Description
Serum level of zinc
Timepoint
Before and the end of the intervention (twelfth week)
Method of measurement
Atomic absorption spectroscopy

7

Description
NLRP3 gene expression
Timepoint
Before and the end of the intervention (twelfth week)
Method of measurement
Real time PCR

8

Description
Caspase-1 gene expression
Timepoint
Before and the end of the intervention (twelfth week)
Method of measurement
Real time PCR

9

Description
Serum level of interleukin-1 beta
Timepoint
Before and the end of the intervention (twelfth week)
Method of measurement
ELISA

10

Description
Serum level of malondialdehyde
Timepoint
Before and the end of the intervention (twelfth week)
Method of measurement
ELISA

11

Description
Serum level of C-reactive protein
Timepoint
Before and the end of the intervention (twelfth week)
Method of measurement
ELISA

Secondary outcomes

1

Description
Quality of life
Timepoint
Before, middle (sixth week) and end of intervention (twelfth week)
Method of measurement
Behçet’s disease quality-of-life (BD-QoL) questionnaire

2

Description
Disease activity
Timepoint
Before, middle (sixth week) and end of intervention (twelfth week)
Method of measurement
Behcets Disease Activity Form

Intervention groups

1

Description
Intervention group: one zinc gluconate tablet daily (120 mg each tablet containing 30 mg elemental zinc) with a meal for 12 weeks
Category
Treatment - Drugs

2

Description
Control group: Placebo (microcrystalline cellulose): 1 tablet (120 mg each) with a meal for 12 weeks
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Rheumatology Clinic of Imam Reza Hospital
Full name of responsible person
Amir Hossein Faghfouri
Street address
Golgasht ST., Imam Reza Hospital
City
Tabriz
Province
East Azarbaijan
Postal code
5166614756
Phone
+98 41 3335 7584
Email
alipourb@tbzmed.ac.ir
Web page address
https://imamreza.tbzmed.ac.ir/

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Mohammad Samiei
Street address
Golgasht St., Tabriz University of Medical Sciences, Vice-chancellor for Research
City
Tabriz
Province
East Azarbaijan
Postal code
5165687386
Phone
+98 41 3335 7310
Email
research-vice@tbzmed.ac.ir
Web page address
https://researchvice.tbzmed.ac.ir/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz 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
Tabriz University of Medical Sciences
Full name of responsible person
Amir Hossein Faghfouri
Position
Ph.D. Student in Nutrition
Latest degree
Master
Other areas of specialty/work
Nutrition
Street address
Attar-e Nishaboori ST- Faculty of Nutrition and Food Sciences
City
Tabriz
Province
East Azarbaijan
Postal code
5183874384
Phone
+98 41 3441 5285
Email
amir.nut89@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr. Beit Allah Alipour
Position
Professor of Nutrition, in Faculty of Nutrition and Food Sciences
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Attar-e Nishaboori ST, Faculty of Nutrition and Food Sciences
City
Tabriz
Province
East Azarbaijan
Postal code
5183874384
Phone
+98 41 3335 7584
Email
alipourb@tbzmed.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Amir Hossein Faghfouri
Position
Ph.D. student in Nutrition
Latest degree
Master
Other areas of specialty/work
Nutrition
Street address
Attar-e Neishaboori ST-Faculty of Nutrition and Food Sciences
City
Tabriz
Province
East Azarbaijan
Postal code
5183874384
Phone
+98 41 3441 5285
Email
amir.nut89@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Not applicable
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
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