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Completed

NCT Number: NCT05098678

Zinc Supplementation and Behçet's Syndrome

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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Key information

Conditions

Behcet Syndrome Cardiovascular Diseases Congenital, Hereditary, and Neonatal Diseases and Abnormalities Eye Diseases Genetic Diseases, Inborn Hereditary Autoinflammatory Diseases Mouth Diseases Panuveitis Skin Diseases Skin Diseases, Genetic Skin Diseases, Vascular Skin and Connective Tissue Diseases Stomatognathic Diseases Uveal Diseases Uveitis Uveitis, Anterior Vascular Diseases Vasculitis

Age range

20 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Tabriz University of Medical Sciences

Tabriz, East Azerbaijan Province, 5166614756, Iran

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Zinc gluconate

Dietary Supplement

120 mg each tablet containing 30 mg elemental zinc

Placebo

Dietary Supplement

Placebo (microcrystalline cellulose): 1 tablet (120 mg each)

Primary outcomes

  1. Toll-like Receptor-2 gene expression

    Time frame: 12 weeks

    2-ΔΔCT

  2. Toll-like Receptor-4 gene expression

    Time frame: 12 weeks

    2-ΔΔCT

  3. Toll-like Receptor-2 protein expression

    Time frame: 12 weeks

    The mean fluorescence intensity

  4. Toll-like Receptor-4 protein expression

    Time frame: 12 weeks

    The mean fluorescence intensity

  5. Serum level of tumor necrosis factor-alpha

    Time frame: 12 weeks

    pg/ml

  6. NLRP3 gene expression

    Time frame: 12 weeks

    2-ΔΔCT

  7. Caspase-1 gene expression

    Time frame: 12 weeks

    2-ΔΔCT

  8. Serum level of interleukin-1 beta

    Time frame: 12 weeks

    pg/ml

  9. Serum level of zinc

    Time frame: 12 weeks

    ug/dl

Secondary outcomes

  1. Behçet's disease quality-of-life

    Time frame: 12 weeks

    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.

  2. Disease activity

    Time frame: 12 weeks

    Behcets Disease Activity

Sponsors and collaborators

Lead sponsor

Tabriz University of Medical Sciences

Other

Registry information

Official study 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

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Oct 28, 2021
Registry last updated
Nov 4, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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