Effect of zinc in treatment of Behcet 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

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20100606004105N30

Enrollment

Registered

2020-08-02

Start date

2020-08-22

Completion date

Unknown

Last updated

2022-08-29

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

Conditions

Behcet Syndrome. Behcet's disease

Interventions

Intervention 1: Intervention group: one zinc gluconate tablet daily (120 mg each tablet containing 30 mg elemental zinc) with a meal for 12 weeks. Intervention 2: Control group: Placebo (microcrystall

Eligibility

Sex/Gender

All

Age

18 Years to 50 Years

Inclusion criteria

Inclusion criteria: Age range 18 to 50 years (premenopausal woman) Diagnosis of Behcet's disease by a rheumatologist according to IBCD (The International Criteria for Behcet’s Disease) which vascular, eyes, and joints complications indicate the severity of the disease Patients who want to participate in the study

Exclusion criteria

Exclusion criteria: Pregnancy and lactation History of diabetes and other chronic diseases History of other autoimmune diseases Taking nutritional supplements and antioxidants and alpha lipoic acid during the month before the study

Design outcomes

Primary

Measure	Time frame
Toll-like Receptor-2 gene expression. Timepoint: Before and the end of the intervention (twelfth week). Method of measurement: Real time PCR.;Toll-like Receptor-4 gene expression. Timepoint: Before and the end of the intervention (twelfth week). Method of measurement: Real time PCR.;Toll-like Receptor-2 protein expression. Timepoint: Before and the end of the intervention (twelfth week). Method of measurement: Flow cytometry.;Toll-like Receptor-4 protein expression. Timepoint: Before and the end of the intervention (twelfth week). Method of measurement: Flow cytometry.;Serum level of tumor necrosis factor-alpha. Timepoint: Before and the end of the intervention (twelfth week). Method of measurement: ELISA.;Serum level of zinc. Timepoint: Before and the end of the intervention (twelfth week). Method of measurement: Atomic absorption spectroscopy.;NLRP3 gene expression. Timepoint: Before and the end of the intervention (twelfth week). Method of measurement: Real time PCR.;Caspase-1 gene expression. Timepoint: Before and the end of the intervention (twelfth week). Method of measurement: Real time PCR.;Serum level of interleukin-1 beta. Timepoint: Before and the end of the intervention (twelfth week). Method of measurement: ELISA.;Serum level of malondialdehyde. Timepoint: Before and the end of the intervention (twelfth week). Method of measurement: ELISA.;Serum level of C-reactive protein. Timepoint: Before and the end of the intervention (twelfth week). Method of measurement: ELISA.	—

Measure

Time frame

Toll-like Receptor-2 gene expression. Timepoint: Before and the end of the intervention (twelfth week). Method of measurement: Real time PCR.;Toll-like Receptor-4 gene expression. Timepoint: Before and the end of the intervention (twelfth week). Method of measurement: Real time PCR.;Toll-like Receptor-2 protein expression. Timepoint: Before and the end of the intervention (twelfth week). Method of measurement: Flow cytometry.;Toll-like Receptor-4 protein expression. Timepoint: Before and the end of the intervention (twelfth week). Method of measurement: Flow cytometry.;Serum level of tumor necrosis factor-alpha. Timepoint: Before and the end of the intervention (twelfth week). Method of measurement: ELISA.;Serum level of zinc. Timepoint: Before and the end of the intervention (twelfth week). Method of measurement: Atomic absorption spectroscopy.;NLRP3 gene expression. Timepoint: Before and the end of the intervention (twelfth week). Method of measurement: Real time PCR.;Caspase-1 gene expression. Timepoint: Before and the end of the intervention (twelfth week). Method of measurement: Real time PCR.;Serum level of interleukin-1 beta. Timepoint: Before and the end of the intervention (twelfth week). Method of measurement: ELISA.;Serum level of malondialdehyde. Timepoint: Before and the end of the intervention (twelfth week). Method of measurement: ELISA.;Serum level of C-reactive protein. Timepoint: Before and the end of the intervention (twelfth week). Method of measurement: ELISA.

—

Secondary

Measure	Time frame
Quality of life. Timepoint: Before, middle (sixth week) and end of intervention (twelfth week). Method of measurement: Behçet’s disease quality-of-life (BD-QoL) questionnaire.;Disease activity. Timepoint: Before, middle (sixth week) and end of intervention (twelfth week). Method of measurement: Behcets Disease Activity Form.	—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactBeitullah Alipour

Tabriz University of Medical Sciences

alipourb@tbzmed.ac.ir+98 41 3441 5285

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026