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COVID-19Phase 2/3ONSCOVID19NCT04323228

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

A Phase 2/3 study testing Oral supplement enriched in antioxidants in people with COVID-19, run by King Saud University at 1 site in Saudi Arabia.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
COVID-19
What is being tested?
Oral supplement enriched in antioxidants
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
40 participants
Where
1 siteSaudi Arabia
Study dates
1 Sep 2020to 30 Dec 2020
Phase
Phase 2/3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

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

00966548155983

mabulmeaty@ksu.edu.sa

Saudi Arabia1 site, 1 recruiting

  • Prince Mohamed BinAbdulaziz Hospital

    Riyadh, 14214

    Abdulla Abdulsalam, MD, 00966112616462, research-dept@pmah.com

    Recruiting

Other trials in Saudi Arabia

About this study

Official title: Anti-inflammatory/Antioxidant Oral Nutrition Supplementation on the Cytokine Storm and Progression of COVID-19: A Randomized Controlled Trial

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.

Read the 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.

Conditions
COVID-19
Being tested
Oral supplement enriched in antioxidants, cellulose-containing placebo capsules
Keywords
COVID-19, Antioxidant ONS, Cytokine storm
Medical subject headings
COVID-19, Cytokine Release Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Oral supplement enriched in antioxidantsDietary 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.

  • cellulose-containing placebo capsulesDietary supplement

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

Study groups in NCT04323228
Study groupRoleWhat they receive
InterventionExperimentalthe 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.
Receives: Dietary Supplement: Oral supplement enriched in antioxidants
PlaceboPlacebo comparatorPlacebo group will receive daily intervention in form of cellulose-containing gelatin capsules with the same color and shape.
Receives: Dietary Supplement: cellulose-containing placebo capsules

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: up to 3 months

  2. 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.

    Measured: up to 3 months

  3. 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

    Measured: up to 3 months

  4. 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

    Measured: up to 3 months

  5. 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

    Measured: up to 3 months

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

    plasma MCP-1 represent severity of the cytokine storm

    Measured: up to 3 months

Secondary outcomes (12)

  1. Change from baseline Weight at end of the trial

    Body weight in Kg

    Measured: up to 3 months

  2. Height

    stature in cm

    Measured: up to 1 month

  3. Change from baseline BMI at end of the trial

    Claculation of BMI according to weight / square Height

    Measured: up to 3 months

  4. Change from baseline mid arm circumference at end of the trial

    changes of MAC in cm

    Measured: up to 3 months

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

    changes of TSF in mm

    Measured: up to 3 months

  6. Change from baseline MAMA at end of the trial

    ). The mid-arm muscle area (MAMA) will be calculated according to the following equation: {MAMA= (MAC - π x TSF)2 / 4π}.

    Measured: Up to 3 months

  7. Change from baseline percentage of peripheral O2 saturation at end of the trial

    changes in the percentage of peripheral O2 saturation by an oximeter

    Measured: up to 3 months

  8. Change from baseline degree of body temperature at end of the trial

    changes in the degree of body temperature by infrared thermometer

    Measured: up to 3 months

  9. Change from baseline count the total leukocyte at end of the trial

    change in the count from complete blood counts

    Measured: up to 3 months

  10. Change from baseline differential lymphocytic count at end of the trial

    change in the count from complete blood counts

    Measured: up to 3 months

  11. Change from baseline Neutrophil count at end of the trial

    change in the count from complete blood counts

    Measured: up to 3 months

  12. Change from baseline neutrophil to lymphocyte ratio at end of the trial

    change in the rations calculated by division of the neutrophil count by the lymphocyte count

    Measured: up to 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Mar 2020
  2. Study start1 Sep 2020
  3. Primary completion1 Dec 2020 (estimated)
  4. Study completion30 Dec 2020 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2/3
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
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 blind
Who is masked
Participant, Care provider
Enrolment
40 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04323228
Sponsor's protocol ID
ONS_COVID-19
Acronym
ONSCOVID19
Status last verified
Sep 2020
First submitted
23 Mar 2020
Last updated
22 Sep 2020
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: all IPD that underlie results in a publication will be shared

Publications

  • 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.

    PubMed 28397943

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

    PubMed 11895145

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

    PubMed 17922951

  • 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; 2026 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK554776/

    PubMed 32150360

  • 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.

    PubMed 28877163

  • 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.

    PubMed 30655992

  • 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.

    PubMed 31986264

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

    PubMed 22028151

  • 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.

    PubMed 12880610

  • 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.

    PubMed 12663270

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

    PubMed 26315574

  • 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.

    PubMed 29878555

  • 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.

    PubMed 32125452

  • 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.

    PubMed 22390970

  • 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.

    PubMed 25516320

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing Oral supplement enriched in antioxidants in people with COVID-19, run by King Saud University at 1 site in Saudi Arabia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 22 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Saudi Arabia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Mahmoud M.A. Abulmeaty, M.D., FACN (00966548155983, mabulmeaty@ksu.edu.sa), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change from baseline score of Nutrition risk screening-2002 (NRS-2002) at end of the trial (time frame: up to 3 months). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04323228, which also lists 15 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Sep 2020.

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