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.
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
- Conditions the study is for
- DHA as Antioxidant Anti-inflammatory Immunomodulation , Overcome Cytokine Storm
- 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.
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
Saudi Arabia1 site
Ministry of health.First health cluster ,Riaydh
Riyadh
hiba kamal abdelseed
Amr K Ahmed
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 group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
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)
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.
- First posted8 Oct 2021
- Study startNov 2021 (estimated)
- Primary completionDec 2021 (estimated)
- Study completionJan 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DHA as Antioxidant Anti-inflammatory Immunomodulation , Overcome Cytokine StormStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Ministry of Health, Saudi Arabia
- Sponsor type
- Other government
- Collaborators
- Kafrelsheikh University
- Responsible party
- Principal investigator, Amr kamel khalil Ahmed, Ministry of Health, Saudi Arabia
- Investigators
- Amr K Ahmed, Principal investigator, Ministry of Health, Saudi ArabiaMahmoud R Elkazzaz, M.Sc of Biochemistry, Principal investigator, Faculty of science Damietta university
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
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- COVID-19: Why Are Children Less Affected
- ClinicalTrials.gov ID
- NCT05071690
- Acronym / sponsor ID
- Observational COVID-19 Study
- Keywords
- breast milk, Algae, DHA, cytokine storm, infant
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Ministry of Health, Saudi ArabiaOther government
- Collaborators
- Kafrelsheikh University
- Study start
- Nov 2021 (estimated)
- Primary completion
- Dec 2021 (estimated)
- Study completion
- Jan 2022 (estimated)
- First posted
- 8 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 1 day to 5 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- all preterm baby and infants and children under 5 years on breat mil or milk formula or DHA supplement
Key inclusion criteria (1 listed)
- full term baby infants and children until 5 years breast feeding or milk formula or supplement on DHA
Key exclusion criteria (1 listed)
- above 5 years no congenital diseases outside kingdom saudia arabia preterm
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
the severity of COVID-19 symptoms at infants and children on DHA at milk formula and on breast feeding
Time frame: 6 month
comparison between two control groups infants and children on breast milk and group on milk formula nouriched at DHA
measurement of percentage of plasma DHA at two groups of infants and children's
Time frame: 6 month
plasma DHA is very important to be measured
1 secondary outcome
THE duration of symptoms at two groups
Time frame: 6 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2021.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Amr K Ahmed principal investigator
Ministry of Health, Saudi Arabia
Mahmoud R Elkazzaz, M.Sc of Biochemistry principal investigator
Faculty of science Damietta university
2 sites in 2 countries: see every site and its status.
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.