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Anti-inflammatory/Antioxidant Oral Nutrition Supplementation in COVID-19 (ONSCOVID19)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04323228
Recruitment Status : Unknown
Verified September 2020 by Mahmoud Abulmeaty, M.D., FACN., King Saud University.
Recruitment status was:  Recruiting
First Posted : March 26, 2020
Last Update Posted : September 22, 2020
Sponsor:
Information provided by (Responsible Party):
Mahmoud Abulmeaty, M.D., FACN., King Saud University

Study Description
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Brief Summary:
COVID-19 pandemic threatens patients, societies and healthcare systems around the world. The host immunity determines the progress of the disease and its lethality. The associated cytokine storm mainly affects the lungs; leading to acute lung injury with variable degrees. Modulation of cytokine production using Immunonutrition is a novel concept that has been applied to other diseases. Using specific nutrients such as n3- fatty acids and antioxidant vitamins in extraordinary doses modulate the host immune response and ameliorate the cytokine storm associated with viral diseases such as COVID-19. In this proposal, we will conduct a prospective double-blinded controlled trial for 14 days on 30 SARS-CoV-2 positive cases. The participant will be randomly assigned to two groups (n=20/each); intervention (IG) and placebo (PG) groups. The IG group will be provided with an anti-inflammatory and antioxidant oral supplement (OS) on a daily basis, while the PG will be given an isocaloric placebo. Basal and weekly nutritional screening, as well as recording of anthropometric, clinical and biochemical parameters, will be done. The main biochemical parameters include serum ferritin level, cytokine storm parameters (interleukin-6, Tumor necrosis factor-α, and monocyte chemoattractant protein 1), C-reactive protein, total leukocyte count, differential lymphocytic count and neutrophil to lymphocyte ratio. It is expected that the anti-inflammatory-antioxidant OS might help in the reduction of the COVID-19 severity with more preservation of the nutritional status of infected cases.

Condition or disease Intervention/treatment Phase
COVID-19 Dietary Supplement: Oral supplement enriched in antioxidants Dietary Supplement: cellulose-containing placebo capsules Phase 2 Phase 3

Detailed Description:

Subjects: A total of 40 participants will be enrolled in this double-blinded prospective, randomized controlled trial. All participants will sign a written consent after details of the study have been fully explained to them. Later on, they will be randomly allocated into two study groups; intervention group (IG, n=20) and placebo group (PG, n=20). Computer-generated random numbers will be used to randomize the participants into one of two intervention groups. The study protocol will be approved by the IRB committee in King Khalid University Hospital, King Saud University Medical city. This clinical trial will be registered in the clinicaltrials.gov registry.

Settings: All participants will be SARS-CoV-2 positive cases admitted to King Khalid University Hospital.

Study protocol: All study participants will be instructed to either consume one capsule of oral supplement enriched in antioxidants vitamins or placebo. The OS will be served in opaque capsules of the same size, shape and color and should be ingested in the morning under the supervision of a nurse. The OS should not be consumed before the time of a meal. The composition of one capsule of the intervention-OS includes: enriched in vitamin A, C, E, Selenium and Zinc. The composition of one capsule of the intervention-supplement includes: 1500 mcg vitamin A (as β-carotene), 250 mg Vitamin C, 90 mg vitamin E, 15 ug Selenium, and 7.5 mg Zinc. The composition of the placebo will have the same weight of cellulose, and zero concentrations of vitamin A, C, E, Selenium and zinc.

All participants will be assessed at the start and reassessed again after 1 week and after 14-days period. The assessment will include nutritional screening by Nutritional risk screening 2002 (NRS-2002), Subjective global assessment (SGA), and Global Leadership Initiative on Malnutrition (GLIM) criteria. Besides anthropometric measures, clinical Global Leadership Initiative on Malnutrition (GLIM). also, anthropometric measurements, clinical assessment, and biochemical data will be measured. Statistical analysis: The Statistical Package for the Social Sciences (SPSS) version 25 will be used for analysis. The descriptive statistics for continuous variables will be presented as mean ± standard deviation, while other categorical variables as percentages. The independent sample t-test will be used for comparison between the IG and PG groups. For repeated measures at multiple points of time will be tested by Friedman's two-way ANOVA. The Pearson correlation coefficient will be applied to correlate some relevant variables. All these tests were performed with 80% power and a 5% level of significance.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Participants will be randomly allocated into two study groups; intervention group (IG, n=20) and placebo group (PG, n=20). Computer-generated random numbers will be used to randomize the participants into one of two intervention groups.
Masking: Double (Participant, Care Provider)
Masking Description: The intervention-supplement and isocaloric-placebo will be served in the same shape, size and color. the care providers (nurses, dietitians) will not know members of each groups or the nature or composition of the ONS.
Primary Purpose: Supportive Care
Official Title: Anti-inflammatory/Antioxidant Oral Nutrition Supplementation on the Cytokine Storm and Progression of COVID-19: A Randomized Controlled Trial
Actual Study Start Date : September 1, 2020
Estimated Primary Completion Date : December 1, 2020
Estimated Study Completion Date : December 30, 2020

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Intervention
the intervention groups will receive daily oral antioxidant supplement enriched in vitamin A, C, E, Selenium and Zinc. The composition of one capsule of the intervention-supplement includes: 1500 mcg vitamin A (as β-carotene), 250 mg Vitamin C, 90 mg vitamin E, 15 ug Selenium, and 7.5 mg Zinc.
 Dietary Supplement: Oral supplement enriched in antioxidants
the intervention group will receive a commercially available antioxidant supplement, which will be given to patients with COVID-19 in the morning after breakfast.
Placebo Comparator: Placebo
Placebo group will receive daily intervention in form of cellulose-containing gelatin capsules with the same color and shape.
 Dietary Supplement: cellulose-containing placebo capsules
The placebo group will receive an oral supplement at the same time in the same shape/size/color.


Outcome Measures
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Primary Outcome Measures :
  1. Change from baseline score of Nutrition risk screening-2002 (NRS-2002) at end of the trial [ Time Frame: up to 3 months ]
    Changes in scores of the NRS-2002 for patients with COVID-19 at the end of the study, from 0 to 7 scores, with those scores < 3 means no risk of malnutrition and >= 3 means malnutrition.

  2. Change from baseline Serum ferritin level at end of the trial [ Time Frame: up to 3 months ]
    Change in serum ferritin at the end of the trial as ferritin is considered as a COVID-19 fatality predictor.

  3. Change from baseline serum Interleukin-6 concentration at end of the trial [ Time Frame: up to 3 months ]
    Change in IL-6 at the end of the trial as it represent the cytokine storm and it is considered as a COVID-19 fatality predictor

  4. Change from baseline serum C-reactive protein concentration at end of the trial [ Time Frame: up to 3 months ]
    Change in C-reactive protein in the serum at the end of the trial which reflect the acute phase

  5. Change from baseline serum Tumor necrosis factor-α concentration at end of the trial [ Time Frame: up to 3 months ]
    Change in the TNF a in the serum at the end of study as it represent severity of the cytokine storm

  6. Change from baseline serum monocyte chemoattractant protein 1 (MCP-1) at end of the trial [ Time Frame: up to 3 months ]
    plasma MCP-1 represent severity of the cytokine storm


Secondary Outcome Measures :
  1. Change from baseline Weight at end of the trial [ Time Frame: up to 3 months ]
    Body weight in Kg

  2. Height [ Time Frame: up to 1 month ]
    stature in cm

  3. Change from baseline BMI at end of the trial [ Time Frame: up to 3 months ]
    Claculation of BMI according to weight / square Height

  4. Change from baseline mid arm circumference at end of the trial [ Time Frame: up to 3 months ]
    changes of MAC in cm

  5. Change from baseline triceps skin-fold thickness at end of the trial [ Time Frame: up to 3 months ]
    changes of TSF in mm

  6. Change from baseline MAMA at end of the trial [ Time Frame: Up to 3 months ]
    ). The mid-arm muscle area (MAMA) will be calculated according to the following equation: {MAMA= (MAC - π x TSF)2 / 4π}.

  7. Change from baseline percentage of peripheral O2 saturation at end of the trial [ Time Frame: up to 3 months ]
    changes in the percentage of peripheral O2 saturation by an oximeter

  8. Change from baseline degree of body temperature at end of the trial [ Time Frame: up to 3 months ]
    changes in the degree of body temperature by infrared thermometer

  9. Change from baseline count the total leukocyte at end of the trial [ Time Frame: up to 3 months ]
    change in the count from complete blood counts

  10. Change from baseline differential lymphocytic count at end of the trial [ Time Frame: up to 3 months ]
    change in the count from complete blood counts

  11. Change from baseline Neutrophil count at end of the trial [ Time Frame: up to 3 months ]
    change in the count from complete blood counts

  12. Change from baseline neutrophil to lymphocyte ratio at end of the trial [ Time Frame: up to 3 months ]
    change in the rations calculated by division of the neutrophil count by the lymphocyte count


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Confirmed SARS-CoV-2 infection
  • COVID-19 patient in stable condition (i.e., not requiring ICU admission).

Exclusion Criteria:

  • Tube feeding or parenteral nutrition.
  • Pregnant or lactating women
  • Admission to ICU > 24 hours
  • participation in another study including any forms of supplementation or disease specific ONS.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04323228


Contacts
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Contact: Mahmoud M.A. Abulmeaty, M.D., FACN 00966548155983 mabulmeaty@ksu.edu.sa

Locations
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Saudi Arabia
Prince Mohamed BinAbdulaziz Hospital Recruiting
Riyadh, Saudi Arabia, 14214
Contact: Abdulla Abdulsalam, MD    00966112616462    research-dept@pmah.com   
Sponsors and Collaborators
King Saud University
More Information
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Additional Information:

Publications:

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Responsible Party: Mahmoud Abulmeaty, M.D., FACN., Associate Professor, King Saud University
ClinicalTrials.gov Identifier: NCT04323228    
Other Study ID Numbers: ONS_COVID-19
First Posted: March 26, 2020    Key Record Dates
Last Update Posted: September 22, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: all IPD that underlie results in a publication will be shared
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)
Time Frame: starting 6 months after publication.
Access Criteria: Access will be available for any researcher interested in this type of research on considerable consent.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Mahmoud Abulmeaty, M.D., FACN., King Saud University:
COVID-19
Antioxidant ONS
Cytokine storm
Additional relevant MeSH terms:
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COVID-19
Pneumonia, Viral
Pneumonia
Respiratory Tract Infections
Infections
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
 Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs