AzTrials
AzTrials

DHA as Antioxidant Anti-inflammatory Immunomodulation , Overcome Cytokine StormNCT05071690

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 of DHA as Antioxidant Anti-inflammatory Immunomodulation , Overcome Cytokine Storm, run by Ministry of Health, Saudi Arabia at 2 sites in 2 countries.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 1 day to 5 yearsHealthy volunteers can take part
How many people
100 participants
Where
2 sitesin 2 countries
Study dates
Nov 2021to Jan 2022
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 1 day to 5 years
  • All sexes
  • Healthy volunteers accepted
  • Child

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

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

2 sites in 2 countries.

Dr Mahmoud R Elkazzaz, M.Sc of Biochemistry contact

+201090302015

mahmoudramadan2051@yahoo.com

2 sites in 2 countries

Egypt1 site
  • Mahmoud

    Kafr ash Shaykh, Kafr Elshiekh, 33511

    Mahmoud R Elkazzaz, 01090302015, mahmoudramadan2051@yahoo.com

    Mahmoud R Elkazzaz, +201090302015 ext. Elkazzaz, mahmoudramadan2051@yahoo.com

Other trials in Egypt

Saudi Arabia1 site
  • Ministry of health.First health cluster ,Riaydh

    Riyadh

    hiba kamal abdelseed

    Amr K Ahmed

Other trials in Saudi Arabia

About this study

Official title: COVID-19: Why Are Children Less Affected

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
Read more

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

Keywords
breast milk, Algae, DHA, cytokine storm, infant
Medical subject headings
Cytokine Release Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT05071690
Study groupRoleWhat they receive
Arm 1on breast milk 50 baby full-term and infant follow up for covid-19 symptoms and measurement of plasma DHA
arm 250 baby depend on DHA source like infant formula milk or supplement with DHA

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: 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

    Measured: 6 month

Secondary outcomes (1)
  1. THE duration of symptoms at two groups

    Measured: 6 month

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Oct 2021
  2. Study startNov 2021 (estimated)
  3. Primary completionDec 2021 (estimated)
  4. Study completionJan 2022 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case-control
Time perspective
Retrospective
Enrolment
100 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05071690
Sponsor's protocol ID
Observational COVID-19 Study
Status last verified
Oct 2021
First submitted
1 Oct 2021
Last updated
19 Oct 2021
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

An observational study of DHA as Antioxidant Anti-inflammatory Immunomodulation , Overcome Cytokine Storm, run by Ministry of Health, Saudi Arabia at 2 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 19 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Egypt, Saudi Arabia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Dr Amr K Ahmed (+966 59 731 0032, drmedahmed@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

the severity of COVID-19 symptoms at infants and children on DHA at milk formula and on breast feeding (time frame: 6 month). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Oct 2021.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in