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

International Journal of Environmental Research and Public Health
Q2
Jan 2022
Citations:19
Influential Citations:2
Interventional (Human) Studies
81
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Enhanced Details

Methods
Randomized, triple-blinded, controlled clinical trial conducted at Centro Medico ISSEMyM Toluca, Mexico. Participants were hospitalized adults aged 30–75 years, both sexes, with COVID-19 stage IIIC and comorbidities (DM2, SAH) and BMI 25–40, with oxygen saturation <90% requiring supplemental oxygen and tolerance to oral intake. Exclusions included respiratory rate >30 bpm, glycemia >250 mg/dL, severe GERD/dysphagia, neurological conditions, recent surgery (<3 months), allergy to NSS components, sepsis, cancer, or chronic degenerative diseases. Eighty participants were randomized (40 CG, 40 IG) and followed for 40 days or until death; randomization used blocks of 10; outcomes assessed by blinded staff.
Intervention
B-complex vitamins: Cyanocobalamin 10 mg, Thiamin 100 mg, Pyridoxine 100 mg; intramuscularly every 24 h for the first 5 days. NSS powder: one envelope after morning meals and another after evening meals, diluted in 400 mL water each, for up to 21 days. Each NSS powder envelope contained: Spirulina Maxima 2.5 g; Folic acid 5 mg; Glutamine 5 g; Vegetable protein 10 g; Brewer's yeast; Amaranth; Ascorbic acid 1 g; Zinc 20 mg; Selenium 100 μg; Cholecalciferol (Vitamin D3) 2000 IU; Resveratrol 200 mg; Omega-3 fatty acids 1 g; L-Arginine 750 mg; Inulin 20 g; Magnesium 400 mg. Probiotics: Saccharomyces boulardii 500 mg daily for 6 days.
Results
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). Discharge home-oxygen dependency was lower in IG (66.7% vs 85.2%; p=0.078). PHQ-9 improved more in IG by day 3 (p=0.003). Post-COVID syndrome and weight loss were numerically lower in IG. Authors conclude NSS increases survival and reduces mortality in hospitalized COVID-19 patients with stage IIIC and comorbidities, highlighting nutritional support and microbiota regulation as determinants of clinical improvement; they call for multicenter replication to confirm and extend findings.
Limitations
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.

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 Supp...