Zinc Supplementation and Behçet's Syndrome

Behcet Syndrome Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05098678
• Other study ID #: 64693
• Status: Completed
• Phase: N/A
• Start date: August 22, 2020
• Est. completion date: September 22, 2021

Study information

• Verified date: October 2021
• Source: Tabriz University of Medical Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: September 22, 2021
• Est. primary completion date: May 22, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Behcet Syndrome
• Syndrome

Intervention

Dietary Supplement:
• Zinc gluconate
120 mg each tablet containing 30 mg elemental zinc
• Placebo
Placebo (microcrystalline cellulose): 1 tablet (120 mg each)

Locations

Country	Name	City	State
Iran, Islamic Republic of	Tabriz University of Medical Sciences	Tabriz	East Azerbaijan

Sponsors (1)

Lead Sponsor	Collaborator
Tabriz University of Medical Sciences

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Toll-like Receptor-2 gene expression	2-??CT	12 weeks
Primary	Toll-like Receptor-4 gene expression	2-??CT	12 weeks
Primary	Toll-like Receptor-2 protein expression	The mean fluorescence intensity	12 weeks
Primary	Toll-like Receptor-4 protein expression	The mean fluorescence intensity	12 weeks
Primary	Serum level of tumor necrosis factor-alpha	pg/ml	12 weeks
Primary	NLRP3 gene expression	2-??CT	12 weeks
Primary	Caspase-1 gene expression	2-??CT	12 weeks
Primary	Serum level of interleukin-1 beta	pg/ml	12 weeks
Primary	Serum level of zinc	ug/dl	12 weeks
Secondary	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
Secondary	Disease activity	Behcets Disease Activity	12 weeks