Effect of a NSS to Reduce Complications in Patients With Covid-19 and Comorbidities in Stage III
NCT ID: NCT04507867
Last Updated: 2021-10-15
Study Results
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View full resultsBasic Information
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COMPLETED
NA
80 participants
INTERVENTIONAL
2020-09-07
2021-04-10
Brief Summary
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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.
Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
SEQUENTIAL
TREATMENT
TRIPLE
Study Groups
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control group
Patients who received the standard diet
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.
Intervention group
Patients who received the nutritional support system (NSS) and the standard diet
Nutritional support system (NSS)
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.
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.
Interventions
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Nutritional support system (NSS)
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.
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.
Eligibility Criteria
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Inclusion Criteria
* 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
* Admission to the ICU for any reason.
* Patients who do not tolerate the oral route.
* Reactions to treatment that compromise the health of patients.
30 Years
75 Years
ALL
No
Sponsors
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Anahuac University
OTHER
Responsible Party
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Fernando Leal-Martinez
Doctor in Clinical Nutrition
Principal Investigators
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Fernado Leal Martínez, Ph.D
Role: PRINCIPAL_INVESTIGATOR
Anahuac University
Locations
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ISSEMYM "Arturo Montiel Rojas" Medical Center
Toluca, State of Mexico, Mexico
Countries
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References
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Document Type: Informed Consent Form
Related Links
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BMI Classification Percentile And Cut Off Points
Diabetes Mellitus Type 2
Cardiovascular Disease
Hyperlipidemia
Chapter 84: Nausea and Vomiting
Acute Headache
Physiology, Respiratory Rate
Oxygen Saturation
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Oxygen Administration
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Antibiotics
Nonsteroidal Anti-inflammatory Drugs (NSAIDs)
Chapter 151: Hemoglobin and Hematocrit
Chapter 152: Red Cell Indices
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Alanine Amino Transferase
Chapter 101: Serum Albumin and Globulin
Calories: Total Macronutrient Intake, Energy Expenditure, and Net Energy Stores
Other Identifiers
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202036
Identifier Type: -
Identifier Source: org_study_id