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
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
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
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
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20100606004105N30
Registration date:2020-08-02, 1399/05/12
Registration timing:prospective
Last update:2020-08-02, 1399/05/12
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
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
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
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
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
empty
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
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
Secondary outcomes
1
Description
Quality of life
Timepoint
Before, middle (sixth week) and end of intervention (twelfth week)