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 determine the effects of zinc gluconate supplementation on several genes expression, serum level of inflammatory factors, quality of life, and disease activity in patients with Behcet syndrome

Double-blind randomized controlled clinical trial (RCT) with parallel design in phase 2-3 on 52 patients with Behcet's syndrome. The STATA software will be used for randomization using ralloc command

A double-blind (participants and researchers) RCT will be performed on 52 Behcet's syndrome patients referred to the Rheumatology Clinic of Tabriz University of Medical Sciences. After random allocation, the intervention group will receive 1 tablet of zinc gluconate (30 mg of elemental zinc) daily and the control group will receive similar placebo for 12 weeks. For blinding, coding of containers is performed by a third person. At the beginning and end of the intervention, 5 cc of fasting blood samples will be collected and international questionnaire of physical activity, quality of life, disease activity and 3-day food record will be completed

Participants: 52 people with Behcet's syndrome of both genders. Inclusion criteria: Aged 18 to 50 years, ability to give informed consent Exclusion criteria: Intake of supplements less than 70%, change in the dosage and type of medication received during the study, pregnancy, lactation, history of chronic diseases and consumption of nutritional supplements during one month prior to the study

The intervention group will receive 1 daily tablet of 30 mg elemental zinc (231 mg zinc gluconate tablet) and the control group will receive similar placebo (cornstarch, and microcrystalline cellulose) for 12 weeks

Inflammatory and antioxidant parameters, quality of life and disease activity

To revise the respondent person

After reaching the inclusion criteria, individuals will be randomly divided into two groups of intervention and placebo by blocking method. Blocking will be performed based on gender and age and whereby the two groups will be matched in terms of age and gender. The four blocks will be created by STATA statistical software using ralloc command, which will be identified by the letters A, B, C, D. The assigned group is not known before the individual assignment.

All tablets (zinc and placebo) in the same shape and color are placed and labeled in the containers by a third person, and two codes are given to individuals, and the codes will be unknown to the researcher until the end of the study.