Zinc Supplementation and Behçet's Syndrome

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05098678

Enrollment

Registered

2021-10-28

Start date

2020-08-22

Completion date

2021-09-22

Last updated

2021-11-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Behcet Syndrome

Brief summary

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.

Interventions

DIETARY_SUPPLEMENTZinc gluconate

120 mg each tablet containing 30 mg elemental zinc

DIETARY_SUPPLEMENTPlacebo

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

20 Years to 50 Years

Healthy volunteers

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

Design outcomes

Primary

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

Secondary

Measure	Time frame	Description
Disease activity	12 weeks	Behcets Disease Activity
Behçet's disease quality-of-life	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.

Countries

Iran

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 18, 2026