Zinc Supplementation and Behçet's Syndrome

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Behcet Syndrome

Intervention / Treatment
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* Dietary Supplement: Zinc gluconate
* Dietary Supplement: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age range 20 to 50 years (premenopausal woman) Diagnosis of Behcet's disease by a rheumatologist according to IBCD (The International Criteria for Behcet's Disease) Patients who want to participate in the study Exclusion Criteria: Pregnancy and lactation History of diabetes and other chronic diseases Smoking and alcohol consumption over the past year History of other autoimmune diseases Consumption of nutritional and antioxidant supplements over two months prior to the study

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Zinc gluconate<br>zinc gluconate tablet daily (120 mg each tablet containing 30 mg elemental zinc) | Dietary Supplement: Zinc gluconate<br>* 120 mg each tablet containing 30 mg elemental zinc<br>|
| Placebo Comparator: Control<br>Placebo (microcrystalline cellulose): 1 tablet (120 mg each) | Dietary Supplement: Placebo<br>* Placebo (microcrystalline cellulose): 1 tablet (120 mg each)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Toll-like Receptor-2 gene expression | 2-ΔΔCT | 12 weeks | 
| Toll-like Receptor-4 gene expression | 2-ΔΔCT | 12 weeks | 
| Toll-like Receptor-2 protein expression | The mean fluorescence intensity | 12 weeks | 
| Toll-like Receptor-4 protein expression | The mean fluorescence intensity | 12 weeks | 
| Serum level of tumor necrosis factor-alpha | pg/ml | 12 weeks | 
| NLRP3 gene expression | 2-ΔΔCT | 12 weeks | 
| Caspase-1 gene expression | 2-ΔΔCT | 12 weeks | 
| Serum level of interleukin-1 beta | pg/ml | 12 weeks | 
| Serum level of zinc | ug/dl | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 12 weeks | 
| Disease activity | Behcets Disease Activity | 12 weeks |