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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Zinc gluconate | Experimental | zinc gluconate tablet daily (120 mg each tablet containing 30 mg elemental zinc) |
|
| Control | Placebo Comparator | Placebo (microcrystalline cellulose): 1 tablet (120 mg each) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Zinc gluconate | Dietary Supplement | 120 mg each tablet containing 30 mg elemental zinc |
| |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tabriz University of Medical Sciences | Tabriz | East Azerbaijan Province | 5166614756 | Iran |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35413570 | Derived | Faghfouri AH, Khabbazi A, Baradaran B, Khajebishak Y, Baghbani E, Noorolyai S, Rahmani S, Seyyed Shoura SM, Alipour M, Alipour B. Immunomodulatory and clinical responses to zinc gluconate supplementation in patients with Behcet's disease: A double-blind, randomized placebo-controlled clinical trial. Clin Nutr. 2022 May;41(5):1083-1092. doi: 10.1016/j.clnu.2022.03.019. Epub 2022 Mar 30. |
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| ID | Term |
|---|---|
| D001528 | Behcet Syndrome |
| ID | Term |
|---|---|
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
| D014606 | Uveitis, Anterior |
| D015864 | Panuveitis |
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| ID | Term |
|---|---|
| C030691 | gluconic acid |
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| Placebo |
| Dietary Supplement |
Placebo (microcrystalline cellulose): 1 tablet (120 mg each) |
|
Behcets Disease Activity
| 12 weeks |
| D014605 |
| Uveitis |
| D014603 | Uveal Diseases |
| D005128 | Eye Diseases |
| D014657 | Vasculitis |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D056660 | Hereditary Autoinflammatory Diseases |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D012873 | Skin Diseases, Genetic |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D017445 | Skin Diseases, Vascular |