Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04507867
Other study ID # 202036
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 7, 2020
Est. completion date April 10, 2021

Study information

Verified date October 2021
Source Anahuac University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Description:

Patients in the COVID-19 area, who are treated at the ISSEMYM Toluca Arturo Montiel Rojas Medical Center, located in Paseo Tollocan, Av. Baja Velocidad km 575, Barrio de Sta Clara, Toluca de Lerdo, México; both sexes, with the presence of comorbidities (type 2 DM, SAH, overweight or obesity BMI <35) and in stage III of the disease. Consecutive cases. With systematic randomized allocation using a sequence of random numbers built with the Excel program divided into two groups. Once the participants of the COVID-19 area have been selected, patients and / or family members will be spoken to to explain the protocol and obtain the signatures of the letters of informed consent. Assignment to the research group will be carried out randomly. Once the patients have been admitted to the study, the following will be carried out: test of COVID-19 by means of PCR, thorax tomography, complete clinical history, Mini Nutritional Assessment (MNA), food diary, list of clinical variables designed by us, complete blood count, coagulation profile, serum electrolytes, blood chemistry (6-elements), lipidic profile, liver function tests, ferritin, fibrinogen, C-reactive protein, procalcitonin and D-dimer. Anthropometric measurements will also be carried out (height, weight, BMI, muscle mass %, fat % and visceral fat%). The follow-up will be carried out daily for 21 days or earlier, if they are discharged from the hospital due to improvement in the evolution, at that moment the patient concludes the study. The following points will be supervised, recording the information in files and photos, since the hospital security protocol does not allow to extract stationery from the COVID-19 area: 1. Application and consumption of NSS supplementation as appropriate. 2. Morning and evening vital signs. 3. Daily clinical evaluation (It includes variables such as oxygen flow, activity level, integrity of the hair, skin and nails, evaluation of the sense of taste and smell, pain, gastrointestinal symptoms, bowel movements, prescribed medications, mood, among others). 4. Anthropometric measurements using a scale every 2 days (only if the patient is stable and can maintain balance). 5. Food diaries of each patient. 6. Laboratory studies every 3 days (previously mentioned). In the same way, the following will be taken into account: the number of days hospitalized, number of patients who progress to ventilation, number of patients who die, number of patients who are extubated and number of days after extubation. A descriptive analysis will be carried out for each continuous variable. These variables will be expressed as mean ± standard deviation and standard error. It will be done according to the distribution of the data; For independent groups with a normal distribution, Student's T will be applied. If the distribution does not meet normality criteria, a Mann Whitney U will be performed; For the follow-up of dependent groups with normal distribution, two-way ANOVA will be applied. If the distribution does not meet normality criteria, a Friedman test will be performed, in both cases post hoc tests will be performed, taking into account that a significant value of p of < 0.05. The results will be analyzed using version 6 of the Graphpad Prism software.


Recruitment information / eligibility

Status Completed
Enrollment 80
Est. completion date April 10, 2021
Est. primary completion date April 10, 2021
Accepts healthy volunteers No
Gender All
Age group 30 Years to 75 Years
Eligibility Inclusion Criteria: - 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. Exclusion Criteria: - 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.

Study Design


Intervention

Dietary Supplement:
Nutritional support system (NSS)
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. Probiotics Saccharomyces boulardii CNCM I-745 "Floratil". One morning and one evening 250 mg capsule during the first 6 days 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.
Other:
Conventional nutritional support designed by hospital nutritionists
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.

Locations

Country Name City State
Mexico ISSEMYM "Arturo Montiel Rojas" Medical Center Toluca de Lerdo Mexico State

Sponsors (1)

Lead Sponsor Collaborator
Anahuac University

Country where clinical trial is conducted

Mexico, 

References & Publications (21)

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. Review. — View Citation

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. Ep — View Citation

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. Review. — View Citation

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. — View Citation

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. Review. — View Citation

Hayiroglu MI, Çinar 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. Review. — View Citation

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):e0 — View Citation

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

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. Review. — View Citation

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. Review. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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 Cri — View Citation

Musso CG, Álvarez-Gregori J, Jauregui J, Macías-Núñez 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. Review. — View Citation

Nuttall FQ. Body Mass Index: Obesity, BMI, and Health: A Critical Review. Nutr Today. 2015 May;50(3):117-128. Epub 2015 Apr 7. — View Citation

Pahan K. Lipid-lowering drugs. Cell Mol Life Sci. 2006 May;63(10):1165-78. Review. — View Citation

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. Review. — View Citation

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. Review. — View Citation

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. — View Citation

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

* Note: There are 21 references in allClick here to view all references

Outcome

Type Measure Description Time frame Safety issue
Other Saturation Without Supplementary Oxygen The oxygen saturation without supplementary oxygen is taken at the control appointment 40 days after hospital discharge. day 40
Other Need for Home Oxygen Flow The need to continue with supplemental oxygen at hospital discharge. Categories: 1. Yes, 2. No. Day 40
Other Time of Home Oxigen Use It is recorded for how many days the treating doctor asked the patients to continue to administer supplemental oxygen after hospital discharge day 40
Other Post Covid Syndrome Persistence of clinical signs and symptoms that arise after developing COVID-19, and are not explained by an alternative diagnosis. 1. Present. 2. Absent. Day 40.
Other Weight Decrease Is defined as at least a 5% reduction in weight from the baseline level.Total number of patients with weight loss at the end of follow-up at day 40 Day 40
Other Gastrointestinal Symptoms Total number of patients with gastrointestinal symptoms at the end of follow-up at day 40.Those symptoms perceived abdominal region (pain, burn, pressure, nausea, vomiting) Day 40
Other Number of Deceased Patients Stratified by Fibrinogen Level. Association between the presentation of certain laboratory parameters taken at baseline with the overall mortality of discharged patients compared to deceased patients. Baseline
Other Number of Deceased Patients Stratified by Procalcitonin Level. Association between the presentation of certain laboratory parameters taken in the baseline period, with te overall mortality of discharge patients in comparison with deceased patients Baseline
Other Number of Deceased Patients Stratified by Ureic Nitrogen Level Association between the presentation of certain laboratory parameters taken in the baseline period, with te overall mortality of discharge patients in comparison with deceased patients Baseline
Other Number of Deceased Participants Stratified by RCP Level Association between the presentation of certain laboratory parameters taken in the baseline period, with te overall mortality of discharge patients in comparison with deceased patients Baseline
Other Number of Deceased Participants Stratified by Neutrophils Level Association between the presentation of certain laboratory parameters taken in the baseline period, with te overall mortality of discharge patients in comparison with deceased patients Baseline
Other Number of Deceased Participants Stratified by Leukocytes Level Association between the presentation of certain laboratory parameters taken in the baseline period, with te overall mortality of discharge patients in comparison with deceased patients Baseline
Other Number of Deceased Participants Stratified by Urea Level Association between the presentation of certain laboratory parameters taken in the baseline period, with te overall mortality of discharge patients in comparison with deceased patients Baseline
Primary Overall Survival Overall survival, the total number of patients included in the study and completed a 40-day follow-up. 40 days.
Primary Overall Mortality at Day 40 Total number of patients who died before day 40 of follow-up. 40 days.
Secondary Survival in Intubated Patients at Day 40 Total number of patients who were intubated, extubated, discharged and completes the 40 day follow-up 40 days
Secondary Mortality in Intubated Patients at Day 40 Patients who were intubated during their hospital stay and died before completing follow-up on day 40. 40 days
Secondary Progression to Mechanical Ventilation Assistance total number of patients included in the study who progressed to mechanical ventilation during the first 10 days of hospital stay. 10 days.
Secondary Participants With Normal Bristol Scale at Day 3 The Bristol Stool Form Scale categorizes stools into one of seven stool types ranging from type 1 (hard lumps) to type 7 (watery diarrhea). Type 3 and 4 were considered "Normal". day 3
Secondary Hidric Balance on Day 3 The ratio between the water assimilated into the body and that lost from the body, in milliliters. It is evaluated on day 3 of hospital stay (duration approximately 10 minutes).
Secondary Oxigen Saturation >90% on Day 3 the total number of patients with oxygen saturation >90% on day 3 of their hospital stay. day 3.
Secondary PHQ-9 Test Is a self-administered version of the PRIME-MD diagnostic instrument for common mental disorders, includes 9 items, which evaluate the presence of depressive symptoms based on the criteria of the Diagnostic and Statistical Manual of Mental Disorders version 4, during the last 2 weeks, how often the patient presented depressive symptoms. According to the sum of the score obtained, the following 4 categories will be considered: 0-4 minimum existence or absence of depressive symptoms; 5-9 = mild depressive symptoms; 10-14 = moderate depressive symptoms; 15-19 = moderate to severe depressive symptoms; 20-27 = severe depressive symptoms. baseline and hospital discharge
Secondary Oxigen Flow (Intragroup) Difference in oxygen delivery between the baseline period and day 3 of hospital stay in each group. baseline and day 3
Secondary qSOFA at Day 3 Quick-Sequential Organ Failure Assessment (qSOFA) score gives 0 to 3 points. =2 in the setting of suspected infection had a high predicted in-hospital mortality rate and could be considered septic. Baseline and Day 3
Secondary Number of Defectations on Day 3 Refers to the subjective sensation of increased abdominal pressure without an increase in abdominal size, the number of defecations were quantified at day 3 and compared between both groups. Day 3
Secondary Number of Participants With Distension on Day 3 Is a visible increase in abdominal girth.1. Present, 2. Absent. Day 3
See also
  Status Clinical Trial Phase
Recruiting NCT04243317 - Feasibility of a Sleep Improvement Intervention for Weight Loss and Its Maintenance in Sleep Impaired Obese Adults N/A
Recruiting NCT04101669 - EndoBarrier System Pivotal Trial(Rev E v2) N/A
Terminated NCT03772886 - Reducing Cesarean Delivery Rate in Obese Patients Using the Peanut Ball N/A
Completed NCT03640442 - Modified Ramped Position for Intubation of Obese Females. N/A
Completed NCT04506996 - Monday-Focused Tailored Rapid Interactive Mobile Messaging for Weight Management 2 N/A
Recruiting NCT06019832 - Analysis of Stem and Non-Stem Tibial Component N/A
Active, not recruiting NCT05891834 - Study of INV-202 in Patients With Obesity and Metabolic Syndrome Phase 2
Active, not recruiting NCT05275959 - Beijing (Peking)---Myopia and Obesity Comorbidity Intervention (BMOCI) N/A
Recruiting NCT04575194 - Study of the Cardiometabolic Effects of Obesity Pharmacotherapy Phase 4
Completed NCT04513769 - Nutritious Eating With Soul at Rare Variety Cafe N/A
Withdrawn NCT03042897 - Exercise and Diet Intervention in Promoting Weight Loss in Obese Patients With Stage I Endometrial Cancer N/A
Completed NCT03644524 - Heat Therapy and Cardiometabolic Health in Obese Women N/A
Recruiting NCT05917873 - Metabolic Effects of Four-week Lactate-ketone Ester Supplementation N/A
Active, not recruiting NCT04353258 - Research Intervention to Support Healthy Eating and Exercise N/A
Recruiting NCT03227575 - Effects of Brisk Walking and Regular Intensity Exercise Interventions on Glycemic Control N/A
Completed NCT01870947 - Assisted Exercise in Obese Endometrial Cancer Patients N/A
Recruiting NCT05972564 - The Effect of SGLT2 Inhibition on Adipose Inflammation and Endothelial Function Phase 1/Phase 2
Recruiting NCT06007404 - Understanding Metabolism and Inflammation Risks for Diabetes in Adolescents
Recruiting NCT05371496 - Cardiac and Metabolic Effects of Semaglutide in Heart Failure With Preserved Ejection Fraction Phase 2
Completed NCT05040971 - Research Study Looking at How Well Semaglutide Works in People Living With Obesity and Prediabetes Phase 3