Effect of co-administration of zinc and vitamin E supplements on plasma concentrations cytokines secreted by T-helper1, 2, and 17 in cardiac surgery patients: Randomized controlled trial

Comparison of the post surgery length of hospital stay in each group and between the two groups Comparison of the plasma concentration of the interferon gamma (Th1 cells cytokine) at the beginning and end of the study Comparison of the plasma concentration of the interleukin 4 (Th2 cells cytokine) at the beginning and end of the study Comparison of the plasma concentration of the interleukin 17 (Th 17 cells cytokine) at the beginning and end of the study

Two arm, parallel, randomized trial with blinded outcome assessment. The sequence of assigning individuals to the study groups is done using Random Allocation Software.

Patient assignment is done by stratified permuted Block Randomization sampling method (stratification by history of diabetes) to two study groups. After surgery, from the second day after admission to the intensive care unit to 3 weeks after surgery, patients of the Intervention group will receive 200 units per day of vitamin E supplement + 40 mg zinc supplement (5 days per week) and the control group will receive the placebo capsules.

Inclusion criteria: -Patients who are candidates for open heart surgery Exclusion criteria: -Frequent use of zinc, vitamin E, multivitamin, and omega-3 supplements during the past month -Chronic rheumatic disease, active cancer treatment, severe infection (WBC>12000 mm3) before surgery, ESRD, liver cirrhosis -Regular use of corticosteroids before heart surgery or continuous use of NSAID drugs during two weeks before admission (except A.S.A.) -Off-pump surgery -Need for re-surgery

Placebo group: Patients will take two placebo tablets daily Zinc+Vitamin E group (Vitamin E in a daily dose of 200 units of alpha tocopherol and zinc in the form of zinc gluconate in a dose of 40 mg, five times a week)

IL-17; IFN gamma concentration

Participants will be randomized to receive vitamin supplement or the placebo. To ensure that the study participants were balanced in two groups, stratified block randomization will be used. Stratification will be based on having/not having diabetes. In each stratum, randomization will be in blocks of four. The sequence of each block will be determined using random assignment software (RAS) with a 1:1 ratio between the two groups in the block. The allocation sequence is placed in an opaque envelope and they are numbered, and during the study they are opened sequentially and people are assigned to groups based on it.

The researcher is aware of the type of supplements used, but due to similar shape and color, they cannot be distinguished by the patient. Also, those responsible for data collection and outcome assessment are blinded to the type of supplement used by the patient.