Observational Study of Infants Fed on DHA (Breast Source or Milk Formula Source ) and Its Effects on Covid-19 Infected Infants and Severity

NCT05071690 | Unknown DMC

• 1 other identifier: Observational COVID-19 Study
• Study Type: observational
• Target: 100
• Locations: 2 countries
• Sites: 2

Brief Summary

Observational Study of Infants Fed on DHA (Breast Source or Milk Formula Source ) and Its Effect on COVID-19 Severity

• Amr kamel khalil Ahmed ( drmedahmed@gmail.com ) 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 ( mahmoudramadan2051@yahoo.com ) 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

Conditions

DHA as Antioxidant Anti-inflammatory Immunomodulation , Overcome Cytokine Storm

Keywords

breast milk, Algae, DHA, cytokine storm, infant

Outcome Measures

Primary Outcomes (2)

• 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

  6 month

• measurement of percentage of plasma DHA at two groups of infants and children's

  plasma DHA is very important to be measured

  6 month

Secondary Outcomes (1)

• THE duration of symptoms at two groups

  6 month

Study Arms (2)

Arm 1

on breast milk 50 baby full-term and infant follow up for covid-19 symptoms and measurement of plasma DHA

arm 2

50 baby depend on DHA source like infant formula milk or supplement with DHA

Eligibility Criteria

• Age: 1 Day - 5 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

Study Population

all preterm baby and infants and children under 5 years on breat mil or milk formula or DHA supplement

You may qualify if:

• full term baby infants and children until 5 years breast feeding or milk formula or supplement on DHA

You may not qualify if:

• above 5 years no congenital diseases outside kingdom saudia arabia preterm

Sponsors & Collaborators

• Ministry of Health, Saudi Arabia: lead
• Faculty of medicine kafr elshiekh university: collaborator

Study Sites (2)

Mahmoud

Kafr ash Shaykh, Kafr Elshiekh, 33511, Egypt

Location

Ministry of health.First health cluster ,Riaydh

Riyadh, Saudi Arabia

Location

MeSH Terms

Conditions

Cytokine Release Syndrome

Condition Hierarchy (Ancestors)

Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Shock

Study Officials

• Amr K Ahmed

  Ministry of Health, Saudia Arabia

  PRINCIPAL INVESTIGATOR

• Mahmoud R Elkazzaz, M.Sc of Biochemistry

  Faculty of science Damietta university

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dr Amr K Ahmed

CONTACT

+966 59 731 0032; drmedahmed@gmail.com

Dr Mahmoud R Elkazzaz, M.Sc of Biochemistry

CONTACT

+201090302015; mahmoudramadan2051@yahoo.com

Study Design

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

Study Record Dates

• First Submitted: October 1, 2021
• First Posted: October 8, 2021
• Study Start: November 1, 2021
• Primary Completion: December 1, 2021
• Study Completion: January 1, 2022
• Last Updated: October 19, 2021

Record last verified: 2021-10

Locations

EG (1); SA (1)