The effect of selenium supplementation on inflammatory markers and blood cells in patients with Covid 19 double-blind randomized clinical trial

The effect of selenium supplementation on inflammatory markers and blood cells in patients with Covid 19 double-blind randomized clinical trial

This study is a randomized double-blind controlled clinical trial with parallel groups. Random assignment of individuals to the intervention or control group will be done using SPSS software.

The study will be performed at Imam Khomeini Hospital in Tehran. The evaluation of variables is done at the beginning and end of the study by sampling the patient's blood. The intervention group received selenium supplementation for two weeks and the control group received the same number of placebo.

We will invite 40 patients with COVID-19 based on inclusion and non-inclusion criteria. Inclusion criteria: 1. Being 20 to 60 years old 2. Diagnosis of COVID-19 based on PCR test 3. Willingness to participate in study 4 Not breastfeeding and not pregnant 5. No advanced respiratory distress syndrome leading to intubation. Exclusion criteria during the study Use of antioxidant supplements during the study.

Intervention group: includes 20 patients with COVID-19 who, in addition to their usual treatments, will take 1 capsule of 200 micrograms of selenium daily for 2 weeks (14 days) after meals. Control group: includes 20 patients with COVID-19 who, in addition to their usual treatments, will take 1 placebo tablet (maltodextrin) daily for 2 weeks after meals. Placebo capsules are very similar in appearance, color, smell and shape to selenium capsules.

1. Serum level of C-reactive protein 2. Serum level of interleukin-6 3. Total number of leukocytes 4. Total number of lymphocytes 5. Total number of neutrophils

Due to the fact that the diagnostic parameters of Covid_19 have changed over the past year, and now the relevant experts use laboratory indicators such as ferritin and lactate dehydrogenase to determine the degree of inflammation caused by the disease, as well as the healing process and the status of Covid_19 patients. Therefore, according to the experts in this field as well as the professors of the infectious diseases and lungs, we decided to add these two laboratory variables to our study. Therefore, in vitro parameters of ferritin and lactate dehydrogenase were added to the initial outcome variables.

Due to the fact that the sample size of these studies is 40 people, to maintain the balance between the two groups, the block randomization method will be used so that 10 four-person blocks including 2 people in the intervention group and 2 others in the placebo group will be formed and distinguished. The placement of individuals in each block will be using a table of random numbers so that in the table of random numbers from top to bottom even numbers will be assigned to the intervention group and odd numbers to the placebo group.

The subjects will be assigned to two groups receiving selenium supplementation and placebo group. The subjects in the intervention group, in addition to their usual treatments, will take 1 capsule of 200 micrograms daily for 2 weeks, and the placebo group will have 1 capsule of placebo daily, which is completely similar in appearance, color, smell and shape to selenium capsules. . The placebo capsule will contain maltodextrin. Supplements and placebos will be provided to patients by a third party who is not directly involved in the research process. Therefore, all patients and researchers will be unaware of the existing grouping. To assess patient admission, a checklist will be prepared and provided to the patient and they will be asked to record their daily intake.

All information can be shared two months after the results are published

Two months after the publication of the results

Physicians, nurses, and infectious disease specialists

To evaluate other complementary therapies and compare its effect with existing treatment related to COVID-19 disease

Send an email to mortezakhamoushi@gmail.com

Two months after the results are published, send a written request to mortezakhamoushi@gmail.com. In this case, and finally within one month after receiving the email, the request will be answered.