Clinical Trial 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
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.
Docosahexaenoic acid (DHA) was detected in abundance in breast milk and other algal sources
milk supplement used for newborns and children's feeding. DHA concentration in breast milk
varies more than 20-fold across human populations (0.06-1.4% by weight).
Naturally, cow's milk does not provide a rich source of DHA however in most companies whole
milk and partially skimmed milk (2%) are fortified with DHA by adding DHA rich feed additive
to Market milk formula. Therefore, we will take a cohort of children and infants who feed on
natural cow's milk without any processing not breast milk or Artificial milk formula
contained on DHA additive as a control.
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.
Therefore, we will take a cohort of adults who did not feed on any Artificial milk formula
contained on DHA additive as a control.
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.
