Zinc Supplementation and Behçet's Syndrome

Not Applicable

Completed

• Conditions: Behcet Syndrome
• Interventions: Dietary Supplement: Placebo; Dietary Supplement: Zinc gluconate

• Registration Number: NCT05098678
• Lead Sponsor: Tabriz University of Medical Sciences

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-08-22
• Primary Completion: 2021-05-22
• Study Completion: 2021-09-22
• Status Verified: 2021-10
• Study First Submitted: 2021-10-15
• Study First Submitted QC: 2021-10-15
• Last Update Submitted: 2021-10-27
• Study First Posted: 2021-10-28
• Last Update Posted: 2021-11-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control	Placebo	Placebo (microcrystalline cellulose): 1 tablet (120 mg each)
Zinc gluconate	Zinc gluconate	zinc gluconate tablet daily (120 mg each tablet containing 30 mg elemental zinc)

Primary Outcome Measures

Name	Time	Method
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
Caspase-1 gene expression	12 weeks	2-ΔΔCT
Serum level of interleukin-1 beta	12 weeks	pg/ml
Serum level of zinc	12 weeks	ug/dl
NLRP3 gene expression	12 weeks	2-ΔΔCT
Serum level of tumor necrosis factor-alpha	12 weeks	pg/ml

Secondary Outcome Measures

Name	Time	Method
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.
Disease activity	12 weeks	Behcets Disease Activity

Trial Locations

Locations (1)

Tabriz University of Medical Sciences; 🇮🇷 Tabriz, East Azerbaijan, Iran, Islamic Republic of