An observational study in DHA as Antioxidant Anti-inflammatory Immunomodulation , Overcome Cytokine Storm, sponsored by Ministry of Health, Saudi Arabia. Status unknown at 2 sites in 2 countries. Open to participants aged 1 Day to 5 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-10-19.
Sponsored by Ministry of Health, Saudi Arabia · Observational
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Observational Study of Infants Fed on DHA (Breast Source or Milk Formula Source ) and Its Effect on COVID-19 Severity
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
the study observational study case control study two groups of infants and children on DHA supplement A arm group on breast milk and measure the DHA level and determine the degree of severity of covid-19 symptoms according the classification of CDC the B arm infants on DHA at milk formula or DHA supplement and measure the DHA level and determine the severity of covid-19 according the classification of CDC
163 studies on the registry are indexed under Cytokine Release Syndrome; 31 are open to participants now.
This study's planned enrollment of 100 is above the median of 86 across 31 observational studies indexed under Cytokine Release Syndrome.
Browse Cytokine Release Syndrome studies →Ministry of Health, Saudi Arabia is the lead sponsor of 21 studies on the registry; 8 are open to participants now.
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all preterm baby and infants and children under 5 years on breat mil or milk formula or DHA supplement
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Exclusion Criteria:
on breast milk 50 baby full-term and infant follow up for covid-19 symptoms and measurement of plasma DHA
50 baby depend on DHA source like infant formula milk or supplement with DHA
the severity of COVID-19 symptoms at infants and children on DHA at milk formula and on breast feeding
comparison between two control groups infants and children on breast milk and group on milk formula nouriched at DHA
Time frame: 6 month
measurement of percentage of plasma DHA at two groups of infants and children's
plasma DHA is very important to be measured
Time frame: 6 month
THE duration of symptoms at two groups
Time frame: 6 month
Start is estimated for Nov 2021; primary completion for Dec 2021, 1 month later.
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This study is status unknown, as verified in Oct 2021. You cannot join it, but the record below documents what was studied.
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Ministry of Health, Saudi Arabia