Comparison of the effectiveness of omega-3 and Hydroxychloroquine on Inflammatory factors, liver enzymes and clinical symptoms in diabetic COVID-19 patients

Determination of the efficacy of omega-3 fatty acids on inflammatory markers, liver enzymes and clinical symptoms in patients with Covid-19.

Randomized clinical trial with parallel control group, single blind (outcome assessor), phase 1, 30 patients, using stratified randomization.

The current trial was performed on diabetic patients with Covid-19 in Amir-Alam hospital in Tehran. The aim and protocol of the study were described for participants. Patients were randomized to intervention or control group. The study was single-blind in which the outcome assessor was not aware about each patient’s group. Before supplementation information about patients including anthropometric indices and physical activity were collected. Moreover, blood sampling and assessment of clinical symptoms including pain, appetite, olfactory and fatigue were conducted at the baseline and end of the trial.

Inclusion criteria: BMI ≥18.5 - age≥18 - Diabetic patients diagnosed with covid-19 according to the decision of the relevant physician- Not consuming any particular diet or supplement as well as not doing any particular physical activity - having tendency to participate in our study Exclusion criteria: Having inflammatory disorders including liver, kidney or thyroid abnormalities, pancreatitis, any malignancy –receiving omega-3 supplements - Pregnancy - Lactating - Menopause - smoking or alcohol intake - having any abnormality in PTT, PT or INR tests

Intervention group: omega-3 (670 mg EPA and DHA) + 400 mg Hydroxychloroquine. Control group: 400 mg Hydroxychloroquine.

Erythrocyte Sedimentation Rate (ESR) and C-reactive protein, alanine aminotransferase (ALT), aspartate amino transferase (AST) and alkaline phosphatase (ALKP) and clinical symptoms including fatigue, body pain, appetite and smelling problem.

Stratified Randomization method was used to control gender and BMI variables. BMI is considered normal (BMI= 18.5- 24.9) and abnormal (BMI≥ 25) and gender is considered as male and female, and thus four lists including women with normal BMI, women with abnormal BMI, men with normal BMI and men with abnormal BMI were considered. Patients were then divided into 2 groups by Permuted Block Randomization. In each separate list, the two-block modes (AB, BA) will be randomly assigned to each treatment order using a random number table. In each list, the order of treatment is determined and therefore, using the double blocks defined according to the random table, patients are placed in equal numbers in each group.

the current study is a single-blinded clinical trial, in which the outcome assessor is not aware of each participant's group.