Effect of a Nutritional Support System to Increase Survival and Reduce Mortality in Patients with COVID-19 in Stage III and Comorbidities: A Blinded Randomized Controlled Clinical Trial
What this study found
Adding NSS to standard care significantly improved outcomes. Day-40 survival was 97.5% in the IG vs 82.5% in the CG (mortality 2.5% vs 17.5%; p=0.027). Progression to mechanical ventilation occurred in 7.5% of IG vs 17.5% of CG (3/40 vs 7/40). Among those who progressed to MVA, survival was 66.7% in IG vs 28.6% in CG, with IG survivors on MVA for 11 days vs 26 days in CG. IG required less supplemental oxygen by day 3 (4.5 L vs 6 L; p=0.014) and showed greater improvement in qSOFA by day 3 (p=0.040). By day 40, SpO2 without supplemental oxygen was higher in IG (92.08% vs 90.39%; p=0.030).…
- Study & population
- Randomized, triple-blinded, controlled clinical trial conducted at Centro Medico ISSEMyM Toluca, Mexico.
- Intervention
- B-complex vitamins: Cyanocobalamin 10 mg, Thiamin 100 mg, Pyridoxine 100 mg; intramuscularly every 24 h for the first 5 days.
- Key limitation
- Small, single-center trial; 80 randomized with 33 CG and 39 IG completing 40-day follow-up; results may not generalize; replication in multicenter studies needed.
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Open PDFOriginal abstract
The COVID-19 evolution depends on immunological capacity. The global hospital mortality rate is 15–20%, but in México it is 46%. There are several therapeutic protocols, however, integral nutrition is not considered. In this study, a Nutritional Support System (NSS) was employed to increase survival and reduce mortality in patients with stage III COVID-19. A randomized, blinded, controlled clinical trial was performed. Eighty patients (aged 30 to 75 years, both sexes) were assigned to (1) “Control Group” (CG) hospital diet and medical treatment or (2) “Intervention Group” (IG) hospital diet, medical treatment, and the NSS (vitamins, minerals, fiber, omega-3, amino acids, B-complex, and probiotics). IG significantly increased survival and reduced mortality compared to CG (p = 0.027). IG decreased progression to Mechanical Ventilation Assistance (MVA) by 10%, reduced the intubation period by 15 days, and increased survival in intubated patients by 38% compared to CG. IG showed improvement compared to CG in decrease in supplemental oxygen (p = 0.014), the qSOFA test (p = 0.040), constipation (p = 0.014), the PHQ-9 test (p = 0.003), and in the follow-up, saturation with oxygen (p = 0.030). The NSS increases survival and decreases mortality in patients with stage III COVID-19.