COVID-19 Clinical Trial
Official title:
Anti-inflammatory/Antioxidant Oral Nutrition Supplementation on the Cytokine Storm and Progression of COVID-19: A Randomized Controlled Trial
COVID-19 pandemic threatens patients, societies and healthcare systems around the world. The host immunity determines the progress of the disease and its lethality. The associated cytokine storm mainly affects the lungs; leading to acute lung injury with variable degrees. Modulation of cytokine production using Immunonutrition is a novel concept that has been applied to other diseases. Using specific nutrients such as n3- fatty acids and antioxidant vitamins in extraordinary doses modulate the host immune response and ameliorate the cytokine storm associated with viral diseases such as COVID-19. In this proposal, we will conduct a prospective double-blinded controlled trial for 14 days on 30 SARS-CoV-2 positive cases. The participant will be randomly assigned to two groups (n=20/each); intervention (IG) and placebo (PG) groups. The IG group will be provided with an anti-inflammatory and antioxidant oral supplement (OS) on a daily basis, while the PG will be given an isocaloric placebo. Basal and weekly nutritional screening, as well as recording of anthropometric, clinical and biochemical parameters, will be done. The main biochemical parameters include serum ferritin level, cytokine storm parameters (interleukin-6, Tumor necrosis factor-α, and monocyte chemoattractant protein 1), C-reactive protein, total leukocyte count, differential lymphocytic count and neutrophil to lymphocyte ratio. It is expected that the anti-inflammatory-antioxidant OS might help in the reduction of the COVID-19 severity with more preservation of the nutritional status of infected cases.
Subjects: A total of 40 participants will be enrolled in this double-blinded prospective,
randomized controlled trial. All participants will sign a written consent after details of
the study have been fully explained to them. Later on, they will be randomly allocated into
two study groups; intervention group (IG, n=20) and placebo group (PG, n=20).
Computer-generated random numbers will be used to randomize the participants into one of two
intervention groups. The study protocol will be approved by the IRB committee in King Khalid
University Hospital, King Saud University Medical city. This clinical trial will be
registered in the clinicaltrials.gov registry.
Settings: All participants will be SARS-CoV-2 positive cases admitted to King Khalid
University Hospital.
Study protocol: All study participants will be instructed to either consume one capsule of
oral supplement enriched in antioxidants vitamins or placebo. The OS will be served in opaque
capsules of the same size, shape and color and should be ingested in the morning under the
supervision of a nurse. The OS should not be consumed before the time of a meal. The
composition of one capsule of the intervention-OS includes: enriched in vitamin A, C, E,
Selenium and Zinc. The composition of one capsule of the intervention-supplement includes:
1500 mcg vitamin A (as β-carotene), 250 mg Vitamin C, 90 mg vitamin E, 15 ug Selenium, and
7.5 mg Zinc. The composition of the placebo will have the same weight of cellulose, and zero
concentrations of vitamin A, C, E, Selenium and zinc.
All participants will be assessed at the start and reassessed again after 1 week and after
14-days period. The assessment will include nutritional screening by Nutritional risk
screening 2002 (NRS-2002), Subjective global assessment (SGA), and Global Leadership
Initiative on Malnutrition (GLIM) criteria. Besides anthropometric measures, clinical Global
Leadership Initiative on Malnutrition (GLIM). also, anthropometric measurements, clinical
assessment, and biochemical data will be measured. Statistical analysis: The Statistical
Package for the Social Sciences (SPSS) version 25 will be used for analysis. The descriptive
statistics for continuous variables will be presented as mean ± standard deviation, while
other categorical variables as percentages. The independent sample t-test will be used for
comparison between the IG and PG groups. For repeated measures at multiple points of time
will be tested by Friedman's two-way ANOVA. The Pearson correlation coefficient will be
applied to correlate some relevant variables. All these tests were performed with 80% power
and a 5% level of significance.
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