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Status unknownNCT05071690Updated Oct 19, 2021

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

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

The sponsor has not verified this record recently (last verified Oct 2021), so the status shown — last known as Not yet recruiting — may be out of date.

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Study type
Observational
Model
Case-control
Time perspective
Retrospective
Enrollment
100
Ages
1 Day to 5 Years
Sex
All
01

Study 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

Read the detailed description

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

02

Conditions studied

  • DHA as Antioxidant Anti-inflammatory Immunomodulation , Overcome Cytokine Storm

Keywords

  • breast milk, Algae, DHA, cytokine storm, infant
03

In context

Cytokine Release Syndrome

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 →

Lead sponsor

Ministry of Health, Saudi Arabia is the lead sponsor of 21 studies on the registry; 8 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
1 Day to 5 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • above 5 years no congenital diseases outside kingdom saudia arabia preterm
05

Study design

Observational model
Case-control
Time perspective
Retrospective
Enrollment
100 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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

06

What researchers measure

Primary outcomes

  1. 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

  2. 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

Secondary outcomes

  1. THE duration of symptoms at two groups

    Time frame: 6 month

07

Study locations

2 sites
  • Mahmoud
    Kafr ash Shaykh, Kafr Elshiekh 33511, Egypt
  • Ministry of health.First health cluster ,Riaydh
    Riyadh, Saudi Arabia
    • hiba kamal abdelseed · Contact
    • Amr K Ahmed · Principal investigator
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Start is estimated for Nov 2021; primary completion for Dec 2021, 1 month later.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 1, 2021
First posted
Oct 8, 2021
StartEst.
Nov 2021
Primary completionEst.
Dec 2021
CompletionEst.
Jan 2022
Last update
Oct 19, 2021
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Oct 19, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05071690
Lead sponsor
Ministry of Health, Saudi Arabia
Responsible party
Amr kamel khalil Ahmed (Clinical Scientist, Ministry of Health, Saudi Arabia) — Principal investigator
First posted
Oct 8, 2021
Start date
Nov 2021 (estimated)
Primary completion
Dec 2021 (estimated)
Completion
Jan 2022 (estimated)
Last update
Oct 19, 2021

Study contacts

Dr Amr K Ahmed
Contact
drmedahmed@gmail.com
+966 59 731 0032
Dr Mahmoud R Elkazzaz, M.Sc of Biochemistry
Contact
mahmoudramadan2051@yahoo.com
+201090302015
Amr K Ahmed
principal investigator · Ministry of Health, Saudi Arabia
Mahmoud R Elkazzaz, M.Sc of Biochemistry
principal investigator · Faculty of science Damietta university

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

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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