Observational Study of Infants Fed on DHA (Breast Source or Milk Formula Source ) and Its Effects on Covid-19 Infected Infants and Severity
NCT ID: NCT05071690
Last Updated: 2021-10-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
100 participants
OBSERVATIONAL
2021-11-30
2022-01-31
Brief Summary
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* Amr kamel khalil Ahmed ( [email protected] ) Director of tuberculosis program Ghubera, public health department ,First health cluster ,Ministry of health , Riyadh, Saudia Arabia https://orcid.org/0000-0003-3477-236X
* Mahmoud Elkazzaz ( [email protected] ) Department of chemistry and biochemistry, Faculty of Science, Damietta University, Egypt https://orcid.org/0000-0003-3703-520X
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 infants and 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 infants and children are also less often infected by SARS-CoV-2 is an ongoing debate. Large epidemiological studies suggest that infants and 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 hospitalization, which is less often the case for children. Some studies suggest that infants and 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
Detailed Description
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Conditions
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Study Design
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CASE_CONTROL
RETROSPECTIVE
Study Groups
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Arm 1
on breast milk 50 baby full-term and infant follow up for covid-19 symptoms and measurement of plasma DHA
No interventions assigned to this group
arm 2
50 baby depend on DHA source like infant formula milk or supplement with DHA
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
1 Day
5 Years
ALL
Yes
Sponsors
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Faculty of medicine kafr elshiekh university
UNKNOWN
Ministry of Health, Saudi Arabia
OTHER_GOV
Responsible Party
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Amr kamel khalil Ahmed
Clinical Scientist
Principal Investigators
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Amr K Ahmed
Role: PRINCIPAL_INVESTIGATOR
Ministry of Health, Saudia Arabia
Mahmoud R Elkazzaz, M.Sc of Biochemistry
Role: PRINCIPAL_INVESTIGATOR
Faculty of science Damietta university
Locations
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Mahmoud
Kafr ash Shaykh, Kafr Elshiekh, Egypt
Ministry of health.First health cluster ,Riaydh
Riyadh, , Saudi Arabia
Countries
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Central Contacts
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Facility Contacts
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hiba kamal abdelseed
Role: primary
Other Identifiers
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Observational COVID-19 Study
Identifier Type: -
Identifier Source: org_study_id