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

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.

Study Overview

• Status: Completed
• Conditions: Behcet Syndrome
• Intervention / Treatment: Dietary supplement: Zinc gluconate; Dietary supplement: Placebo

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Iran, Islamic Republic of
  • East Azerbaijan
    • Tabriz, East Azerbaijan, Iran, Islamic Republic of, 5166614756
      • Tabriz University of Medical Sciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 48 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Zinc gluconate; zinc gluconate tablet daily (120 mg each tablet containing 30 mg elemental zinc)	Dietary supplement: Zinc gluconate; 120 mg each tablet containing 30 mg elemental zinc
Placebo Comparator: Control; Placebo (microcrystalline cellulose): 1 tablet (120 mg each)	Dietary supplement: Placebo; Placebo (microcrystalline cellulose): 1 tablet (120 mg each)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	Behcets Disease Activity	12 weeks

Collaborators and Investigators

• Sponsor: Tabriz University of Medical Sciences

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): August 22, 2020
• Primary Completion (Actual): May 22, 2021
• Study Completion (Actual): September 22, 2021

Study Registration Dates

• First Submitted: October 15, 2021
• First Submitted That Met QC Criteria: October 15, 2021
• First Posted (Actual): October 28, 2021

Study Record Updates

• Last Update Posted (Actual): November 4, 2021
• Last Update Submitted That Met QC Criteria: October 27, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Skin Diseases; Eye Diseases; Disease; Genetic Diseases, Inborn; Stomatognathic Diseases; Mouth Diseases; Uveitis, Anterior; Panuveitis; Uveitis; Uveal Diseases; Vasculitis; Hereditary Autoinflammatory Diseases; Skin Diseases, Genetic; Skin Diseases, Vascular; Syndrome; Behcet Syndrome
• Other Study ID Numbers: 64693

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No