Effect of a NSS to Reduce Complications in Patients With Covid-19 and Comorbidities in Stage III

NCT04507867 | Completed Results DMC

• 1 other identifier: 202036
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

The disease caused by SARS-CoV-2, has derived a pandemic in which its evolution and complications depend on the immune capacity of the host. The virus has been characterized by presenting an inflammatory cascade, increased by the overproduction of proinflammatory cytokines, the decrease in metalloenzymes and also the rapid spread of the virus. There are several lines of treatment, however, nutritional treatment only considered a caloric intake. For this reason, this study will evaluate the evolution of patients with COVID-19 assisted by nutritional support system and the effect of this therapy in reducing complications and comorbidities. Research question: Will the nutritional support system reduce complications in stage III positive COVID-19 patients with comorbidities (type 2 DM, SAH, overweight / obesity with BMI \<35), with a better benefit than that achieved with the conventional nutritional treatment ?. Hypothesis: The nutritional support system will reduce the complications of patients with COVID-19 in stage III with comorbidities. General Objective: To determine the effect of the use of a nutritional support system on complications in patients with COVID-19 in stage III with comorbidities. Methodology: A controlled, blinded, randomized clinical trial will be conducted in patients with COVID-19, hospitalized at the ISSEMYM Toluca Arturo Montiel Rojas Medical Center, who meet the inclusion criteria. The evolution of the group of patients receiving the nutritional support system (NSS) and the normal diet implemented by the hospital will be evaluated against the group of patients receiving only the diet, using clinical examination, laboratory and cabinet tests during their hospital stay. Statistical analysis: for independent groups with normal distribution, Student's T will be applied. If the distribution does not meet normality criteria, a Mann Whitney U will be performed; Two-way ANOVA will be applied to monitor the groups over time with normal distribution. If the distribution does not meet normality criteria, a Friedman test will be performed, in both cases post hoc tests will be performed. The results will be analyzed using version 6 of the Graphpad Prism software.

Conditions

COVID19; Diabetes Mellitus; Hypertension; Obesity; Overweight; Oxygen Saturation; Mortality; Inflammation

Keywords

COVID19; Nutritional support; SARS-COV-2; Pneumonia; Supplementation; Probiotics

Outcome Measures

Primary Outcomes (2)

• Overall Survival

  Overall survival, the total number of patients included in the study and completed a 40-day follow-up.

  40 days.

• Overall Mortality at Day 40

  Total number of patients who died before day 40 of follow-up.

  40 days.

Secondary Outcomes (11)

• Survival in Intubated Patients at Day 40

  40 days

• Mortality in Intubated Patients at Day 40

  40 days

• Progression to Mechanical Ventilation Assistance

  10 days.

• Participants With Normal Bristol Scale at Day 3

  day 3

• Hidric Balance on Day 3

  It is evaluated on day 3 of hospital stay (duration approximately 10 minutes).

Other Outcomes (13)

• Saturation Without Supplementary Oxygen

  day 40

• Need for Home Oxygen Flow

  Day 40

• Time of Home Oxigen Use

  day 40

Study Arms (2)

control group

SHAM COMPARATOR

Patients who received the standard diet

Other: Conventional nutritional support designed by hospital nutritionists

Intervention group

EXPERIMENTAL

Patients who received the nutritional support system (NSS) and the standard diet

Dietary Supplement: Nutritional support system (NSS); Other: Conventional nutritional support designed by hospital nutritionists

Interventions

Nutritional support system (NSS) DIETARY_SUPPLEMENT

1. Combination of three B vitamins (B1, B6 and B12) "Neurobion" 10 mg solution for IM injection, One every 24 hours for the first 5 days. 2. Probiotics Saccharomyces boulardii CNCM I-745 "Floratil". One morning and one evening 250 mg capsule during the first 6 days 3. One envelope of NSS-1 in the morning and one envelope in the afternoon mixed with 400 ml of water each, contain nutritional support system.

Intervention group

Conventional nutritional support designed by hospital nutritionists OTHER

Diet designed by the nutrition department according to comorbidities and intubation probability. Food will be established according to the provisions of the ISSEMYM Toluca Arturo Montiel Rojas Medical Center.

Intervention group; control group

Eligibility Criteria

• Age: 30 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients admitted to the ISSEMYM Toluca Medical Center "Arturo Montiel Rojas ", diagnosed with COVID-19 confirmed by PCR.
• Patients in need of supplemental O2 with nasal prongs or reservoir-mask for satO2 \<90% and respiratory distress.
• With concomitant diseases such as cardiovascular disease, diabetes mellitus 2, hypertension, overweight or obesity BMI \<35.
• Both sexes.
• Over 30 years old.
• The patient tolerate oral feeding.
• Signing of the letter of informed consent.

You may not qualify if:

• Detachment from treatment.
• Admission to the ICU for any reason.
• Patients who do not tolerate the oral route.
• Reactions to treatment that compromise the health of patients.

Sponsors & Collaborators

• Anahuac University: lead

Study Sites (1)

ISSEMYM "Arturo Montiel Rojas" Medical Center

Toluca, State of Mexico, 52140, Mexico

Location

Related Publications (22)

• Hummel T, Landis BN, Huttenbrink KB. Smell and taste disorders. GMS Curr Top Otorhinolaryngol Head Neck Surg. 2011;10:Doc04. doi: 10.3205/cto000077. Epub 2012 Apr 26.

  PMID: 22558054 RESULT

• Mortazavi H, Shafiei S, Sadr S, Safiaghdam H. Drug-related Dysgeusia: A Systematic Review. Oral Health Prev Dent. 2018;16(6):499-507. doi: 10.3290/j.ohpd.a41655.

  PMID: 30574604 RESULT

• Chumpitazi BP, Self MM, Czyzewski DI, Cejka S, Swank PR, Shulman RJ. Bristol Stool Form Scale reliability and agreement decreases when determining Rome III stool form designations. Neurogastroenterol Motil. 2016 Mar;28(3):443-8. doi: 10.1111/nmo.12738. Epub 2015 Dec 21.

  PMID: 26690980 RESULT

• Seo AY, Kim N, Oh DH. Abdominal bloating: pathophysiology and treatment. J Neurogastroenterol Motil. 2013 Oct;19(4):433-53. doi: 10.5056/jnm.2013.19.4.433. Epub 2013 Oct 7.

  PMID: 24199004 RESULT

• Silva DAS, de Lima TR, Tremblay MS. Association between Resting Heart Rate and Health-Related Physical Fitness in Brazilian Adolescents. Biomed Res Int. 2018 Jun 28;2018:3812197. doi: 10.1155/2018/3812197. eCollection 2018.

  PMID: 30050928 RESULT

• Moskowitz A, Patel PV, Grossestreuer AV, Chase M, Shapiro NI, Berg K, Cocchi MN, Holmberg MJ, Donnino MW; Center for Resuscitation Science. Quick Sequential Organ Failure Assessment and Systemic Inflammatory Response Syndrome Criteria as Predictors of Critical Care Intervention Among Patients With Suspected Infection. Crit Care Med. 2017 Nov;45(11):1813-1819. doi: 10.1097/CCM.0000000000002622.

  PMID: 28759474 RESULT

• Holvoet E, Vanden Wyngaert K, Van Craenenbroeck AH, Van Biesen W, Eloot S. The screening score of Mini Nutritional Assessment (MNA) is a useful routine screening tool for malnutrition risk in patients on maintenance dialysis. PLoS One. 2020 Mar 4;15(3):e0229722. doi: 10.1371/journal.pone.0229722. eCollection 2020.

  PMID: 32130271 RESULT

• Nuttall FQ. Body Mass Index: Obesity, BMI, and Health: A Critical Review. Nutr Today. 2015 May;50(3):117-128. doi: 10.1097/NT.0000000000000092. Epub 2015 Apr 7.

  PMID: 27340299 RESULT

• Babiker A, Al Dubayee M. Anti-diabetic medications: How to make a choice? Sudan J Paediatr. 2017;17(2):11-20. doi: 10.24911/SJP.2017.2.12.

  PMID: 29545660 RESULT

• Pahan K. Lipid-lowering drugs. Cell Mol Life Sci. 2006 May;63(10):1165-78. doi: 10.1007/s00018-005-5406-7.

  PMID: 16568248 RESULT

• Ghoshal K, Bhattacharyya M. Overview of platelet physiology: its hemostatic and nonhemostatic role in disease pathogenesis. ScientificWorldJournal. 2014 Mar 3;2014:781857. doi: 10.1155/2014/781857. eCollection 2014.

  PMID: 24729754 RESULT

• Selders GS, Fetz AE, Radic MZ, Bowlin GL. An overview of the role of neutrophils in innate immunity, inflammation and host-biomaterial integration. Regen Biomater. 2017 Feb;4(1):55-68. doi: 10.1093/rb/rbw041.

  PMID: 28149530 RESULT

• Hayiroglu MI, Cinar T, Tekkesin AI. Fibrinogen and D-dimer variances and anticoagulation recommendations in Covid-19: current literature review. Rev Assoc Med Bras (1992). 2020 Jun;66(6):842-848. doi: 10.1590/1806-9282.66.6.842. Epub 2020 Jul 20.

  PMID: 32696883 RESULT

• Knovich MA, Storey JA, Coffman LG, Torti SV, Torti FM. Ferritin for the clinician. Blood Rev. 2009 May;23(3):95-104. doi: 10.1016/j.blre.2008.08.001. Epub 2008 Oct 2.

  PMID: 18835072 RESULT

• Liu F, Li L, Xu M, Wu J, Luo D, Zhu Y, Li B, Song X, Zhou X. Prognostic value of interleukin-6, C-reactive protein, and procalcitonin in patients with COVID-19. J Clin Virol. 2020 Jun;127:104370. doi: 10.1016/j.jcv.2020.104370. Epub 2020 Apr 14.

  PMID: 32344321 RESULT

• Kashani K, Rosner MH, Ostermann M. Creatinine: From physiology to clinical application. Eur J Intern Med. 2020 Feb;72:9-14. doi: 10.1016/j.ejim.2019.10.025. Epub 2019 Nov 8.

  PMID: 31708357 RESULT

• Wang H, Ran J, Jiang T. Urea. Subcell Biochem. 2014;73:7-29. doi: 10.1007/978-94-017-9343-8_2.

  PMID: 25298336 RESULT

• Musso CG, Alvarez-Gregori J, Jauregui J, Macias-Nunez JF. Glomerular filtration rate equations: a comprehensive review. Int Urol Nephrol. 2016 Jul;48(7):1105-10. doi: 10.1007/s11255-016-1276-1. Epub 2016 Apr 6.

  PMID: 27052619 RESULT

• Hamade B, Huang DT. Procalcitonin: Where Are We Now? Crit Care Clin. 2020 Jan;36(1):23-40. doi: 10.1016/j.ccc.2019.08.003. Epub 2019 Oct 21.

  PMID: 31733680 RESULT

• Driscoll JJ, Rixe O. Overall survival: still the gold standard: why overall survival remains the definitive end point in cancer clinical trials. Cancer J. 2009 Sep-Oct;15(5):401-5. doi: 10.1097/PPO.0b013e3181bdc2e0.

  PMID: 19826360 RESULT

• Kroenke K, Spitzer RL, Williams JB. The PHQ-9: validity of a brief depression severity measure. J Gen Intern Med. 2001 Sep;16(9):606-13. doi: 10.1046/j.1525-1497.2001.016009606.x.

  PMID: 11556941 RESULT

• Shakoor H, Feehan J, Al Dhaheri AS, Cheikh Ismail L, Ali HI, Alhebshi SH, Apostolopoulos V, Stojanovska L. Role of vitamin D supplementation in aging patients with COVID-19. Maturitas. 2021 Oct;152:63-65. doi: 10.1016/j.maturitas.2021.03.006. Epub 2021 Mar 16. No abstract available.

  PMID: 33757717 DERIVED

Related Links

• BMI Classification Percentile And Cut Off Points
• Diabetes Mellitus Type 2
• Cardiovascular Disease
• Hyperlipidemia
• Dyspnea
• Chapter 84: Nausea and Vomiting
• Acute Headache
• Myalgia
• Diarrhea
• Physiology, Respiratory Rate
• Oxygen Saturation
• How is body temperature regulated and what is fever?
• Oxygen Administration
• Antihypertensive Medications
• Antibiotics
• Antacids
• Nonsteroidal Anti-inflammatory Drugs (NSAIDs)
• Chapter 151: Hemoglobin and Hematocrit
• Chapter 152: Red Cell Indices
• Histology, White Blood Cell
• Blood Glucose Monitoring
• Physiology, Cholesterol
• Alanine Amino Transferase
• Chapter 101: Serum Albumin and Globulin
• Calories: Total Macronutrient Intake, Energy Expenditure, and Net Energy Stores

MeSH Terms

Conditions

COVID-19; Diabetes Mellitus; Hypertension; Obesity; Overweight; Inflammation; Pneumonia

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Vascular Diseases; Cardiovascular Diseases; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pathologic Processes

Limitations and Caveats

Restriction of resources for laboratory tests, small number of subjects analyzed and restriction of access of measuring instruments to the COVID-19 area.

Results Point of Contact

• Title: Dr. Fernando Leal Martínez
• Organization: Universidad Anáhuac México Norte

ferman5@hotmail.com

+52 5521094339

Study Officials

• Fernado Leal Martínez, Ph.D

  Anahuac University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: blinding was planned for patients and evaluators (treating physicians , care provider and laboratory personnel)
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor in Clinical Nutrition

Model Details: exploratory study, it is a controlled, blinded, randomized clinical trial design.

Study Record Dates

• First Submitted: August 6, 2020
• First Posted: August 11, 2020
• Study Start: September 7, 2020
• Primary Completion: April 10, 2021
• Study Completion: April 10, 2021
• Last Updated: October 15, 2021
• Results First Posted: October 15, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

ME (1)