Anti-inflammatory/Antioxidant Oral Nutrition Supplementation in COVID-19

NCT04323228 | Unknown Phase 2 DMC

• 1 other identifier: ONS_COVID-19
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

COVID-19

Keywords

COVID-19; Antioxidant ONS; Cytokine storm

Outcome Measures

Primary Outcomes (6)

• Change from baseline score of Nutrition risk screening-2002 (NRS-2002) at end of the trial

  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.

  up to 3 months

• Change from baseline Serum ferritin level at end of the trial

  Change in serum ferritin at the end of the trial as ferritin is considered as a COVID-19 fatality predictor.

  up to 3 months

• Change from baseline serum Interleukin-6 concentration at end of the trial

  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

  up to 3 months

• Change from baseline serum C-reactive protein concentration at end of the trial

  Change in C-reactive protein in the serum at the end of the trial which reflect the acute phase

  up to 3 months

• Change from baseline serum Tumor necrosis factor-α concentration at end of the trial

  Change in the TNF a in the serum at the end of study as it represent severity of the cytokine storm

  up to 3 months

• Change from baseline serum monocyte chemoattractant protein 1 (MCP-1) at end of the trial

  plasma MCP-1 represent severity of the cytokine storm

  up to 3 months

Secondary Outcomes (12)

• Change from baseline Weight at end of the trial

  up to 3 months

• Height

  up to 1 month

• Change from baseline BMI at end of the trial

  up to 3 months

• Change from baseline mid arm circumference at end of the trial

  up to 3 months

• Change from baseline triceps skin-fold thickness at end of the trial

  up to 3 months

Study Arms (2)

Intervention

EXPERIMENTAL

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

Placebo

PLACEBO COMPARATOR

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

Interventions

Oral supplement enriched in antioxidants DIETARY_SUPPLEMENT

the intervention group will receive a commercially available antioxidant supplement, which will be given to patients with COVID-19 in the morning after breakfast.

Intervention

cellulose-containing placebo capsules DIETARY_SUPPLEMENT

The placebo group will receive an oral supplement at the same time in the same shape/size/color.

Placebo

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• King Saud University: lead

Study Sites (1)

Prince Mohamed BinAbdulaziz Hospital

Riyadh, 14214, Saudi Arabia

RECRUITING

Related Publications (15)

• Abulmeaty MM, Almajwal AM, Almadani NK, Aldosari MS, Alnajim AA, Ali SB, Hassan HM, Elkatawy HA. Anthropometric and central obesity indices as predictors of long-term cardiometabolic risk among Saudi young and middle-aged men and women. Saudi Med J. 2017 Apr;38(4):372-380. doi: 10.15537/smj.2017.4.18758.

  PMID: 28397943 BACKGROUND

• Grimm H, Calder PC. Immunonutrition. Br J Nutr. 2002 Jan;87 Suppl 1:S1. doi: 10.1079/bjn2001450. No abstract available.

  PMID: 11895145 BACKGROUND

• Calder PC. Immunonutrition in surgical and critically ill patients. Br J Nutr. 2007 Oct;98 Suppl 1:S133-9. doi: 10.1017/S0007114507832909.

  PMID: 17922951 BACKGROUND

• Cascella M, Rajnik M, Aleem A, Dulebohn SC, Di Napoli R. Features, Evaluation, and Treatment of Coronavirus (COVID-19). 2023 Aug 18. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2025 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK554776/

  PMID: 32150360 BACKGROUND

• Das SK, Chisti MJ, Sarker MHR, Das J, Ahmed S, Shahunja KM, Nahar S, Gibbons N, Ahmed T, Faruque ASG, Rahman M, J Fuchs G 3rd, Al Mamun A, John Baker P. Long-term impact of changing childhood malnutrition on rotavirus diarrhoea: Two decades of adjusted association with climate and socio-demographic factors from urban Bangladesh. PLoS One. 2017 Sep 6;12(9):e0179418. doi: 10.1371/journal.pone.0179418. eCollection 2017.

  PMID: 28877163 BACKGROUND

• Harada K, Minami H, Ferdous T, Kato Y, Umeda H, Horinaga D, Uchida K, Park SC, Hanazawa H, Takahashi S, Ohota M, Matsumoto H, Maruta J, Kakutani H, Aritomi S, Shibuya K, Mishima K. The Elental(R) elemental diet for chemoradiotherapy-induced oral mucositis: A prospective study in patients with oral squamous cell carcinoma. Mol Clin Oncol. 2019 Jan;10(1):159-167. doi: 10.3892/mco.2018.1769. Epub 2018 Nov 16.

  PMID: 30655992 BACKGROUND

• Huang C, Wang Y, Li X, Ren L, Zhao J, Hu Y, Zhang L, Fan G, Xu J, Gu X, Cheng Z, Yu T, Xia J, Wei Y, Wu W, Xie X, Yin W, Li H, Liu M, Xiao Y, Gao H, Guo L, Xie J, Wang G, Jiang R, Gao Z, Jin Q, Wang J, Cao B. Clinical features of patients infected with 2019 novel coronavirus in Wuhan, China. Lancet. 2020 Feb 15;395(10223):497-506. doi: 10.1016/S0140-6736(20)30183-5. Epub 2020 Jan 24.

  PMID: 31986264 BACKGROUND

• Kim H. Glutamine as an immunonutrient. Yonsei Med J. 2011 Nov;52(6):892-7. doi: 10.3349/ymj.2011.52.6.892.

  PMID: 22028151 BACKGROUND

• Kondrup J, Allison SP, Elia M, Vellas B, Plauth M; Educational and Clinical Practice Committee, European Society of Parenteral and Enteral Nutrition (ESPEN). ESPEN guidelines for nutrition screening 2002. Clin Nutr. 2003 Aug;22(4):415-21. doi: 10.1016/s0261-5614(03)00098-0.

  PMID: 12880610 BACKGROUND

• McCowen KC, Bistrian BR. Immunonutrition: problematic or problem solving? Am J Clin Nutr. 2003 Apr;77(4):764-70. doi: 10.1093/ajcn/77.4.764.

  PMID: 12663270 BACKGROUND

• Mariette C. Immunonutrition. J Visc Surg. 2015 Aug;152 Suppl 1:S14-7. doi: 10.1016/S1878-7886(15)30005-9.

  PMID: 26315574 BACKGROUND

• McCarthy MS, Martindale RG. Immunonutrition in Critical Illness: What Is the Role? Nutr Clin Pract. 2018 Jun;33(3):348-358. doi: 10.1002/ncp.10102.

  PMID: 29878555 BACKGROUND

• Ruan Q, Yang K, Wang W, Jiang L, Song J. Clinical predictors of mortality due to COVID-19 based on an analysis of data of 150 patients from Wuhan, China. Intensive Care Med. 2020 May;46(5):846-848. doi: 10.1007/s00134-020-05991-x. Epub 2020 Mar 3. No abstract available.

  PMID: 32125452 BACKGROUND

• Tisoncik JR, Korth MJ, Simmons CP, Farrar J, Martin TR, Katze MG. Into the eye of the cytokine storm. Microbiol Mol Biol Rev. 2012 Mar;76(1):16-32. doi: 10.1128/MMBR.05015-11.

  PMID: 22390970 BACKGROUND

• Teo BW, Toh QC, Chan XW, Xu H, Li JL, Lee EJ. Assessment of muscle mass and its association with protein intake in a multi-ethnic Asian population: relevance in chronic kidney disease. Asia Pac J Clin Nutr. 2014;23(4):619-25. doi: 10.6133/apjcn.2014.23.4.01.

  PMID: 25516320 BACKGROUND

Related Links

• Immunonutrition: Interactions of Diet, Genetics, and Inflammation - Google Books. In Immunonutrition: Interactions of Diet, Genetics, and Inflammation

MeSH Terms

Conditions

COVID-19; Cytokine Release Syndrome

Interventions

Antioxidants

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Shock

Intervention Hierarchy (Ancestors)

Biological Factors; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Protective Agents; Physiological Effects of Drugs; Specialty Uses of Chemicals

Central Study Contacts

Mahmoud M.A. Abulmeaty, M.D., FACN

CONTACT

00966548155983; mabulmeaty@ksu.edu.sa

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: 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.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: 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.

Study Record Dates

• First Submitted: March 23, 2020
• First Posted: March 26, 2020
• Study Start: September 1, 2020
• Primary Completion: December 1, 2020
• Study Completion: December 30, 2020
• Last Updated: September 22, 2020

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, 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.

Locations

SA (1)