Could Docosahexaenoic Acid (DHA), Contained in Breast Milk and Artificial Baby Milks, Protect Infants and Children From COVID-19 and Make Them Less Prone to COVID-19-related Severe Illness Than Adults?

NCT05075031 | Unknown DMC

• 1 other identifier: Observational COVID-19 Study
• Study Type: observational
• Target: 1,500
• Locations: 0 countries
• Sites: N/A

Brief Summary

Could Docosahexaenoic Acid (DHA) Protect Infants and Children From COVID-19 and Make Them Less Susceptible to COVID-19-related Severe Illness Than Adults?

• The study is configured as a retrospective and prospective observational study. The study will be multi-center and will involve all Infants and Children feeding on breast milk or Artificial milk formula that contained on DHA.
• Human milk is the best form of infant nutrition providing significant protection against many illnesses for term and preterm infants.
• This study seeks to investigate the possible protective role of DHA found in Breast Milk or Artificial Milk Formula that are used for feeding of Children and Infants.
• This study would examine the electronic patient record of Newborn from birth to about 2 months of age and Infants from 2 months to 1 year old as well as children from 1year to age 5 years old , feeding on Breast Milk or Artificial Milk Formula between March 2020 and October 2021 and compare their rates of Covid-19 infection, hospitalization and complications with the rates of the local age-matched background population.
• As Covid-19 is a new disease, the existing research literature on this specific topic is extremely limited, and so far this study would be the first in this area. Abstract The novel SARS-CoV-2, which causes the disease called COVID-19, has rapidly spread across the globe. A striking and consistent observation has been the difference in severity of COVID-19 at different ages: severity, the need for hospitalization and mortality rise steeply with older age while severe disease and death are relatively rare in children and young adults. Most children infected with SARS-CoV-2 are asymptomatic or have mild symptoms, most commonly fever, cough, pharyngitis, gastrointestinal symptoms and changes in sense of smell or taste. Whether children are also less often infected by SARS-CoV-2 is an ongoing debate. Large epidemiological studies suggest that children comprise only 1 to 2% of all SARS-CoV-2 cases. However, these numbers heavily depend on testing criteria and, in many reports, testing was done only in individuals who were symptomatic or required hospitalisation, which is less often the case for children. Some studies suggest that children are just as likely as adults to become infected with SARS-CoV-2.9 However, more recent studies report that children are less likely to get infected after contact with a SARS-CoV-2-positive individual.10-14 It has been suggested that children and adolescents have similar viral loads and may therefore be as likely to transmit SARS-CoV-2 as adults. In addition, the viral load may be similar in asymptomatic and symptomatic individuals. However, reassuringly, transmission in schools from children either to other children or to adults has been rare. The observation that children are less often infected with SARS-CoV-2 and that they have less severe symptoms is similar to that reported for SARS-CoV-1 and Middle East respiratory syndrome (MERS)-CoV. However, this pattern is strikingly different to that for infection with most other respiratory viruses (eg, respiratory syncytial virus (RSV), metapneumovirus, parainfluenza or influenza viruses), for which the prevalence and severity are both higher in children. Dr Amr kamel khalil Ahmed and Dr. Mahmoud Elkazzaz, the lead investigators of this observational study , recently published a preprint that demonstrated Docosahexaenoic acid (DHA) had a high binding affinity and greatest interactions with ACE2 active sites, as well as a moderate binding affinity and moderate interactions with the active sites of IL-6. The Docosahexaenoic acid (DHA) interacts with different active sites of IL6 and ACE2 which are involved in direct or indirect contacts with the ACE2 and IL-6 receptors which might act as potential blockers of functional ACE2 and IL-6 receptor complex. Docosahexaenoic acid (DHA) was detected in abundance in breast milk and other algal sources milk supplement used for newborns and children's feeding. As a result, we believe that docosahexaenoic acid (DHA) may protect children and newborns thorough competing with COVID-19 for ACE2 receptors and inhibiting IL-6 activity and may possibly help them avoid a cytokine storm and save their lives through inhibiting IL-6 and preventing SARS-CoV-2 RBD attachment to ACE2

Conditions

COVID19

Outcome Measures

Primary Outcomes (1)

• Susceptibility for COVID-19.

  Did infants and children who were fed breast milk or artificial milk formula have a lower risk of infection with Covid-19? in comparison with the control groups

  March2020 - October 2021

Secondary Outcomes (6)

• Severity for COVID-19.

  March2020 - October 2021

• Mortality

  March2020 - October 2021

• Care and Critical Care

  March2020 - October 2021

• Resolution of fever

  March2020 - October 2021

• Percentage of children requiring intensive care support

  March2020 - October 2021

Study Arms (5)

300 Newborn feeding on Breast Milk or Artificial Milk Formula rom birth to about 2 months of age

The electronic patient record of 300 Newborn feeding on Breast Milk or Artificial Milk Formula from birth to about 2 months of age would be examined and followed between March 2020 and October 2021 and compare their rates of Covid-19 infection, hospitalization and complications with the rates of the Control Groups

300 Infant feeding on Breast Milk or Artificial Milk Formula from 2 months to 1 year

The electronic patient record of 300 Infant feeding on Breast Milk or Artificial Milk Formula from 2 months to 1 year would be examined and followed between March 2020 and October 2021 and compare their rates of Covid-19 infection, hospitalization and complications with the rates of the rates of the Control Groups

300 child feeding on Breast Milk or Artificial Milk Formula from 1 year to 5 year

The electronic patient record of 300 child feeding on Breast Milk or Artificial Milk Formula from 1 year to 5 year would be examined and followed between March 2020 and October 2021 and compare their rates of Covid-19 infection, hospitalization and complications with the rates of the rates of the Control Groups

300 child feeding on Breast Milk or Artificial Milk Formula from 5 year up to 15 year

The electronic patient record of 300 child feeding on Artificial Milk Formula or any source of DHA from 5 year up to 15 year would be examined and followed between March 2020 and October 2021 and compare their rates of Covid-19 infection, hospitalization and complications with the rates of the Control Groups

Control Group

1. The electronic patient record of 150 infant and child patients who feed on only cow's milk which does not provide a rich source of DHA and did not feed on any Artificial Milk Formula or any source of DHA would be examined and followed between March 2020 and October 2021 and compare their rates of Covid-19 infection, hospitalization and complications with the rates of the cohorts that feed on Breast Milk or Artificial Milk Formula 2. The electronic patient record of 150 adult patients from 15 years to 25 years who did not feed on any Artificial Milk Formula or any source of DHA would be examined and followed between March 2020 and October 2021

Eligibility Criteria

• Age: 1 Day - 25 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Newborn Infants and children feeding on Breast Milk or Artificial Milk Formula in the range from birth to about 15 years of age would be examined and followed between March 2020 and October 2021 and compare their rates of Covid-19 infection, hospitalization and complications with the rates of the Control Groups

You may qualify if:

• Newborn feeding on Breast Milk or Artificial Milk Formula from birth to about 2 months of age.
• Infant feeding on Breast Milk or Artificial Milk Formula from 2 months to 1 year
• Children feeding on Breast Milk or Artificial Milk Formula from 1 year to 5 year.
• Children feeding on Breast Milk or Artificial Milk Formula from 5 year up to 15 year
• Adult patients from 15 years to 25 years who did not feed on any Artificial Milk Formula or any source of DHA .
• Infants and children patients who feed on only cow's milk which does not provide a rich source of DHA and did not feed on any Artificial Milk Formula or any source of DHA

You may not qualify if:

• Age above 25 years.
• Adult patients from 15 years to 25 years who feed on any Artificial Milk Formula or any source of DHA ..

Sponsors & Collaborators

• Kafrelsheikh University: lead
• Ministry of Health, Saudia Arabia: collaborator

Related Links

• Natural phytochemicals, Phenformin, and Docosahexaenoic acid (DHA) as a Novel Inhibitors of IL-6 and ACE2 receptors, a Therapeutic Strategy for targeting COVID-19 Cell Entry and Cytokine Storm. An insilico Approach

MeSH Terms

Conditions

COVID-19

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

Study Officials

• Dr Mahmoud R Elkazzaz, M.Sc of Biochemistry

  Faculty of Science Damietta University

  PRINCIPAL INVESTIGATOR

• Dr Amr K Ahmed

  Ministry of Health, Saudia Arabia

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dr Mahmoud R Elkazzaz, M.Sc of Biochemistry

CONTACT

00201090302015; mahmoudramadan2051@yahoo.com

Dr Amr K Ahmed

CONTACT

+966 59 731 0032; drmedahmed@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Scientist

Study Record Dates

• First Submitted: October 6, 2021
• First Posted: October 12, 2021
• Study Start: December 1, 2021
• Primary Completion: January 1, 2022
• Study Completion: February 1, 2022
• Last Updated: October 12, 2021

Record last verified: 2021-10