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CompletedNCT04507867Updated Oct 15, 2021Results posted

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

An interventional study of Nutritional support system (NSS) and Conventional nutritional support designed by hospital nutritionists in COVID19, Diabetes Mellitus and Hypertension, sponsored by Anahuac University. Completed at 1 site in Mexico. Open to participants aged 30 Years to 75 Years. Per ClinicalTrials.gov, last updated 2021-10-15.

Sponsored by Anahuac University · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
80
Allocation
Randomized
Ages
30 Years to 75 Years
Sex
All
01

Study 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.

Read the detailed 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.

02

Conditions studied

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

Keywords

  • COVID19
  • Nutritional support
  • SARS-COV-2
  • Pneumonia
  • Supplementation
  • Probiotics
03

In context

COVID-19

7,640 studies on the registry are indexed under COVID-19; 488 are open to participants now.

This study's enrollment of 80 is below the median of 100 across 4,099 interventional studies indexed under COVID-19.

Browse COVID-19 studies →

Lead sponsor

Anahuac University is the lead sponsor of 10 studies on the registry; 4 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
30 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Sequential assignment
Masking
Triple (Participant, Care provider, Outcomes assessor)
Enrollment
80 participants (actual)

Study arms

  • Sham comparator
    control group

    Patients who received the standard diet

    Other: Conventional nutritional support designed by hospital nutritionists

  • Experimental
    Intervention group

    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

  • Dietary supplementNutritional 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.

  • OtherConventional 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.

06

What researchers measure

Primary outcomes

  1. Overall Survival

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

    Time frame: 40 days.

  2. Overall Mortality at Day 40

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

    Time frame: 40 days.

Secondary outcomes

  1. Survival in Intubated Patients at Day 40

    Total number of patients who were intubated, extubated, discharged and completes the 40 day follow-up

    Time frame: 40 days

  2. Mortality in Intubated Patients at Day 40

    Patients who were intubated during their hospital stay and died before completing follow-up on day 40.

    Time frame: 40 days

  3. 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.

    Time frame: 10 days.

  4. 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".

    Time frame: day 3

  5. Hidric Balance on Day 3

    The ratio between the water assimilated into the body and that lost from the body, in milliliters.

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

  6. Oxigen Saturation >90% on Day 3

    the total number of patients with oxygen saturation \>90% on day 3 of their hospital stay.

    Time frame: day 3.

  7. 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.

    Time frame: baseline and hospital discharge

  8. Oxigen Flow (Intragroup)

    Difference in oxygen delivery between the baseline period and day 3 of hospital stay in each group.

    Time frame: baseline and day 3

  9. 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.

    Time frame: Baseline and Day 3

  10. 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.

    Time frame: Day 3

  11. Number of Participants With Distension on Day 3

    Is a visible increase in abdominal girth.1. Present, 2. Absent.

    Time frame: Day 3

Other outcomes

  1. Saturation Without Supplementary Oxygen

    The oxygen saturation without supplementary oxygen is taken at the control appointment 40 days after hospital discharge.

    Time frame: day 40

  2. Need for Home Oxygen Flow

    The need to continue with supplemental oxygen at hospital discharge. Categories: 1. Yes, 2. No.

    Time frame: Day 40

  3. 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

    Time frame: day 40

  4. 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.

    Time frame: Day 40.

  5. 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

    Time frame: Day 40

  6. 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)

    Time frame: Day 40

  7. 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.

    Time frame: Baseline

  8. 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

    Time frame: Baseline

  9. 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

    Time frame: Baseline

  10. 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

    Time frame: Baseline

  11. 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

    Time frame: Baseline

  12. 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

    Time frame: Baseline

  13. 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

    Time frame: Baseline

07

Results

Posted Oct 15, 2021
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.

Participant flow

Participant flow — Overall Study
MilestoneControl GroupIntervention Group
Started4040
Completed3339
Not completed71
Withdrew: Death71

Outcome measures

PrimaryOverall Survival

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

Time frame:
40 days.
Reported as:
Count of participants · Participants
Overall Survival
ParticipantsControl GroupIntervention Group
Overall Survival3339
Statistical analysis
  • Control Group vs Intervention Group · Log Rank · p = 0.027
PrimaryOverall Mortality at Day 40

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

Time frame:
40 days.
Reported as:
Count of participants · Participants
Overall Mortality at Day 40
ParticipantsControl GroupIntervention Group
Overall Mortality at Day 4071
SecondarySurvival in Intubated Patients at Day 40

Total number of patients who were intubated, extubated, discharged and completes the 40 day follow-up

Time frame:
40 days
Reported as:
Count of participants · Participants
Survival in Intubated Patients at Day 40
ParticipantsControl GroupIntervention Group
Survival in Intubated Patients at Day 4022
Statistical analysis
  • Control Group vs Intervention Group · Log Rank · p = 0.495
SecondaryMortality in Intubated Patients at Day 40

Patients who were intubated during their hospital stay and died before completing follow-up on day 40.

Time frame:
40 days
Reported as:
Count of participants · Participants
Mortality in Intubated Patients at Day 40
ParticipantsControl GroupIntervention Group
Mortality in Intubated Patients at Day 4051
SecondaryProgression 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.

Time frame:
10 days.
Reported as:
Count of participants · Participants
Progression to Mechanical Ventilation Assistance
ParticipantsControl GroupIntervention Group
Progression to Mechanical Ventilation Assistance73
Statistical analysis
  • Control Group vs Intervention Group · Log Rank · p = 0.186
SecondaryParticipants 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".

Time frame:
day 3
Reported as:
Count of participants · Participants
Participants With Normal Bristol Scale at Day 3
ParticipantsControl GroupIntervention Group
Participants With Normal Bristol Scale at Day 3813
Statistical analysis
  • Control Group vs Intervention Group · Fisher Exact · p = 0.35
SecondaryHidric Balance on Day 3

The ratio between the water assimilated into the body and that lost from the body, in milliliters.

Time frame:
It is evaluated on day 3 of hospital stay (duration approximately 10 minutes).
Reported as:
Mean · milliliters
Hidric Balance on Day 3
millilitersControl GroupIntervention Group
Hidric Balance on Day 3123.4 ± 453.8456.6 ± 485.5
Statistical analysis
  • Control Group vs Intervention Group · t-test, 1 sided · p = 0.043
SecondaryOxigen Saturation >90% on Day 3

the total number of patients with oxygen saturation \>90% on day 3 of their hospital stay.

Time frame:
day 3.
Reported as:
Count of participants · Participants
Oxigen Saturation >90% on Day 3
ParticipantsControl GroupIntervention Group
Oxigen Saturation >90% on Day 33437
Statistical analysis
  • Control Group vs Intervention Group · Fisher Exact · p = 0.241
SecondaryPHQ-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.

Time frame:
baseline and hospital discharge
Reported as:
Mean · score on a scale
PHQ-9 Test
score on a scaleControl GroupIntervention Group
Baseline3.66 ± 2.55.3 ± 3.4
Hospital discharge1.50 ± 2.81.9 ± 1.4
Statistical analysis
  • Control Group · t-test, 2 sided · p = 0.187
  • Intervention Group · t-test, 2 sided · p = 0.003
SecondaryOxigen Flow (Intragroup)

Difference in oxygen delivery between the baseline period and day 3 of hospital stay in each group.

Time frame:
baseline and day 3
Reported as:
Mean · Liters (L)
Oxigen Flow (Intragroup)
Liters (L)Control GroupIntervention Group
Baseline5.9 ± 3.86 ± 3.2
Day 36 ± 4.44.5 ± 3.5
Statistical analysis
  • Control Group · t-test, 2 sided · p = 0.919
  • Intervention Group · t-test, 2 sided · p = 0.014
SecondaryqSOFA 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.

Time frame:
Baseline and Day 3
Reported as:
Mean · score on a scale
qSOFA at Day 3
score on a scaleControl GroupIntervention Group
Baseline0.42 ± 0.590.65 ± 0.62
Day 30.51 ± 0.570.43 ± 0.49
Statistical analysis
  • Control Group · Wilcoxon (Mann-Whitney) · p = 0.608
  • Intervention Group · t-test, 2 sided · p = 0.04
SecondaryNumber 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.

Time frame:
Day 3
Reported as:
Mean · defecations
Number of Defectations on Day 3
defecationsControl GroupIntervention Group
Number of Defectations on Day 30.81 ± 0.901.41 ± 1.13
Statistical analysis
  • Control Group vs Intervention Group · Wilcoxon (Mann-Whitney) · p = 0.014
SecondaryNumber of Participants With Distension on Day 3

Is a visible increase in abdominal girth.1. Present, 2. Absent.

Time frame:
Day 3
Reported as:
Number · percent of participants
Number of Participants With Distension on Day 3
percent of participantsControl GroupIntervention Group
Number of Participants With Distension on Day 351.619.4
Statistical analysis
  • Control Group vs Intervention Group · Fisher Exact · p = 0.008the shapiro wilk test was used to analyze the distribution of the data.
Other pre-specifiedSaturation Without Supplementary Oxygen

The oxygen saturation without supplementary oxygen is taken at the control appointment 40 days after hospital discharge.

Time frame:
day 40
Reported as:
Mean · percentage
Saturation Without Supplementary Oxygen
percentageControl GroupIntervention Group
Saturation Without Supplementary Oxygen90.39 ± 3.492.08 ± 2.5
Other pre-specifiedNeed for Home Oxygen Flow

The need to continue with supplemental oxygen at hospital discharge. Categories: 1. Yes, 2. No.

Time frame:
Day 40
Reported as:
Count of participants · Participants
Need for Home Oxygen Flow
ParticipantsControl GroupIntervention Group
Need for Home Oxygen Flow2326
Statistical analysis
  • Control Group vs Intervention Group · Fisher Exact · p = 0.078
Other pre-specifiedTime 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

Time frame:
day 40
Reported as:
Mean · days
Time of Home Oxigen Use
daysControl GroupIntervention Group
Time of Home Oxigen Use57.6 ± 24.643.8 ± 16.2
Statistical analysis
  • Control Group vs Intervention Group · t-test, 1 sided · p = 0.098
Other pre-specifiedPost 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.

Time frame:
Day 40.
Reported as:
Count of participants · Participants
Post Covid Syndrome
ParticipantsControl GroupIntervention Group
Post Covid Syndrome98
Statistical analysis
  • Control Group vs Intervention Group · Fisher Exact · p = 0.195
Other pre-specifiedWeight 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

Time frame:
Day 40
Reported as:
Count of participants · Participants
Weight Decrease
ParticipantsControl GroupIntervention Group
Weight Decrease88
Statistical analysis
  • Control Group vs Intervention Group · Fisher Exact · p = 0.135
Other pre-specifiedGastrointestinal 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)

Time frame:
Day 40
Reported as:
Count of participants · Participants
Gastrointestinal Symptoms
ParticipantsControl GroupIntervention Group
Gastrointestinal Symptoms43
Statistical analysis
  • Control Group vs Intervention Group · Fisher Exact · p = 0.266
Other pre-specifiedNumber 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.

Time frame:
Baseline
Reported as:
Count of participants · Participants
Number of Deceased Patients Stratified by Fibrinogen Level.
ParticipantsFibrinogen <700 mg/dLFibrinogen >700 mg/dL
Number of Deceased Patients Stratified by Fibrinogen Level.26
Statistical analysis
  • Fibrinogen <700 mg/dL vs Fibrinogen >700 mg/dL · Fisher Exact · p = 0.002
Other pre-specifiedNumber 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

Time frame:
Baseline
Reported as:
Count of participants · Participants
Number of Deceased Patients Stratified by Procalcitonin Level.
ParticipantsProcalcitonin <0.5 ng/mLProcalcitonin >0.5 ng/mL
Number of Deceased Patients Stratified by Procalcitonin Level.44
Statistical analysis
  • Procalcitonin <0.5 ng/mL vs Procalcitonin >0.5 ng/mL · Fisher Exact · p = 0.003
Other pre-specifiedNumber 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

Time frame:
Baseline
Reported as:
Count of participants · Participants
Number of Deceased Patients Stratified by Ureic Nitrogen Level
ParticipantsUreic Nitrogen <22 mg/dLUreic Nitrogen >22 mg/dL
Number of Deceased Patients Stratified by Ureic Nitrogen Level44
Statistical analysis
  • Ureic Nitrogen <22 mg/dL vs Ureic Nitrogen >22 mg/dL · Fisher Exact · p = 0.004
Other pre-specifiedNumber 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

Time frame:
Baseline
Reported as:
Count of participants · Participants
Number of Deceased Participants Stratified by RCP Level
ParticipantsRCP <150 mg/LRCP >150 mg/L
Number of Deceased Participants Stratified by RCP Level17
Statistical analysis
  • RCP <150 mg/L vs RCP >150 mg/L · Fisher Exact · p = 0.011
Other pre-specifiedNumber 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

Time frame:
Baseline
Reported as:
Count of participants · Participants
Number of Deceased Participants Stratified by Neutrophils Level
ParticipantsNeutrophils <80%Neutrophils >80%
Number of Deceased Participants Stratified by Neutrophils Level08
Statistical analysis
  • Neutrophils <80% vs Neutrophils >80% · Fisher Exact · p = 0.031
Other pre-specifiedNumber 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

Time frame:
Baseline
Reported as:
Count of participants · Participants
Number of Deceased Participants Stratified by Leukocytes Level
ParticipantsLeukocytes <10x10^3/μLLeukocytes >10x10^3/μL
Number of Deceased Participants Stratified by Leukocytes Level35
Statistical analysis
  • Leukocytes <10x10^3/μL vs Leukocytes >10x10^3/μL · Fisher Exact · p = 0.040
Other pre-specifiedNumber 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

Time frame:
Baseline
Reported as:
Count of participants · Participants
Number of Deceased Participants Stratified by Urea Level
ParticipantsUrea <40 mg/dLUrea >40 mg/dL
Number of Deceased Participants Stratified by Urea Level44
Statistical analysis
  • Urea <40 mg/dL vs Urea >40 mg/dL · Fisher Exact · p = 0.047

Adverse events

Collected over 40 days.. Non-serious events are listed at a 4% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Control Group7/40 (17.5%)0/40 (0%)0/40 (0%)
Intervention Group1/40 (2.5%)0/40 (0%)5/40 (12.5%)
Most frequent other events
Most frequent other events
EventControl GroupIntervention Group
ConstipationGastrointestinal disorders0/405/40

Baseline characteristics

all participants enrolled in the study, a total of 80 patients were compared.

Age, Continuous
Age, Continuous(years)Control GroupIntervention GroupTotal
Mean53.9 ± 10.351.5 ± 11.452.7 ± 10.9
Sex: Female, Male
Sex: Female, Male(Participants)Control GroupIntervention GroupTotal
Female131528
Male272552
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)Control GroupIntervention GroupTotal
Hispanic or Latino404080
Not Hispanic or Latino000
Unknown or Not Reported000
Region of Enrollment
Region of Enrollment(participants)Control GroupIntervention GroupTotal
Mexico404080
Overweight
Overweight(Participants)Control GroupIntervention GroupTotal
Count of participants383674
Obesity Type I-II
Obesity Type I-II(Participants)Control GroupIntervention GroupTotal
Count of participants141327
Diabetes Mellitus 2
Diabetes Mellitus 2(Participants)Control GroupIntervention GroupTotal
Count of participants131124
Cardiovascular Disease and/or Hypertension
Cardiovascular Disease and/or Hypertension(Participants)Control GroupIntervention GroupTotal
Count of participants171027

51 further baseline measures are reported on the registry.

08

Study locations

1 site
  • ISSEMYM "Arturo Montiel Rojas" Medical Center
    Toluca de Lerdo, Mexico State 52140, Mexico
09

References and documents

Publications

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  • 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. PubMed 30574604 ↗
  • 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. PubMed 26690980 ↗
  • 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. PubMed 24199004 ↗
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Study documents

  • Study protocol · Jul 28, 2020
  • Statistical analysis plan · Jul 28, 2021
  • Informed consent form · Jul 28, 2020

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 15, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04507867
Lead sponsor
Anahuac University
Responsible party
Fernando Leal-Martinez (Doctor in Clinical Nutrition, Anahuac University) — Principal investigator
First posted
Aug 11, 2020
Start date
Sep 7, 2020
Primary completion
Apr 10, 2021
Completion
Apr 10, 2021
Results posted
Oct 15, 2021
Last update
Oct 15, 2021

Study contacts

Fernado Leal Martínez, Ph.D
principal investigator · Anahuac University

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2021. You cannot join it, but the record below documents what was studied.

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