To study the effects of zinc gluconate supplementation on patients with Behçet's syndrome, 50 patients will be randomly allocated to two groups: placebo group or zinc group (one tablet of 30 mg/day elemental zinc) for 12 weeks. All participants will be asked not to alter their diet, medication, and physical activity during the study. At the first and the end of the intervention, genes and proteins expression, the serum level of inflammatory factors, quality of life, disease activity, anthropometric measures, physical activity and serum level of zinc will be assessed and compared between groups.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
50
120 mg each tablet containing 30 mg elemental zinc
Placebo (microcrystalline cellulose): 1 tablet (120 mg each)
Tabriz University of Medical Sciences
Tabriz, East Azerbaijan Province, Iran
Toll-like Receptor-2 gene expression
2-ΔΔCT
Time frame: 12 weeks
Toll-like Receptor-4 gene expression
2-ΔΔCT
Time frame: 12 weeks
Toll-like Receptor-2 protein expression
The mean fluorescence intensity
Time frame: 12 weeks
Toll-like Receptor-4 protein expression
The mean fluorescence intensity
Time frame: 12 weeks
Serum level of tumor necrosis factor-alpha
pg/ml
Time frame: 12 weeks
NLRP3 gene expression
2-ΔΔCT
Time frame: 12 weeks
Caspase-1 gene expression
2-ΔΔCT
Time frame: 12 weeks
Serum level of interleukin-1 beta
pg/ml
Time frame: 12 weeks
Serum level of zinc
ug/dl
Time frame: 12 weeks
Behçet's disease quality-of-life
Behçet's disease quality-of-life. The score ranged between 0-30. Zero means high quality of life and 30 means low quality of life.
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Time frame: 12 weeks
Disease activity
Behcets Disease Activity
Time frame: 12 weeks