COVID19NCT05075031
Could Docosahexaenoic Acid (DHA), Contained in Breast Milk and Artificial Baby Milks, Protect Infants and Children From COVID-19 and Make Them Less Prone to COVID-19-related Severe Illness Than Adults?
An observational study of COVID19, run by Kafrelsheikh University.
Trial summary
Could Docosahexaenoic Acid (DHA) Protect Infants and Children From COVID-19 and Make Them Less Susceptible to COVID-19-related Severe Illness Than Adults? The study is configured as a retrospective and prospective observational study. Read more about this study
- Who is it for?
- Ages 1 day to 25 years
- Conditions the study is for
- COVID19
- How many people
- 1,500 participants
- Where
- No sites listed yet
- Study dates
- Dec 2021to Feb 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 25 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Newborn Infants and children feeding on Breast Milk or Artificial Milk Formula in the range from birth to about 15 years of age would be examined and followed between March 2020 and October 2021 and compare their rates of Covid-19 infection, hospitalization and complications with the rates of the Control Groups
Who may be able to join
- Newborn feeding on Breast Milk or Artificial Milk Formula from birth to about 2 months of age.
- Infant feeding on Breast Milk or Artificial Milk Formula from 2 months to 1 year
- Children feeding on Breast Milk or Artificial Milk Formula from 1 year to 5 year.
- Children feeding on Breast Milk or Artificial Milk Formula from 5 year up to 15 year
- Adult patients from 15 years to 25 years who did not feed on any Artificial Milk Formula or any source of DHA .
- Infants and children patients who feed on only cow's milk which does not provide a rich source of DHA and did not feed on any Artificial Milk Formula or any source of DHA
Who cannot join
- Age above 25 years.
- Adult patients from 15 years to 25 years who feed on any Artificial Milk Formula or any source of DHA ..
Trial locations and contacts
No sites are listed yet.
About this study
Could Docosahexaenoic Acid (DHA) Protect Infants and Children From COVID-19 and Make Them Less Susceptible to COVID-19-related Severe Illness Than Adults?
- The study is configured as a retrospective and prospective observational study. The study will be multi-center and will involve all Infants and Children feeding on breast milk or Artificial milk formula that contained on DHA.
- Human milk is the best form of infant nutrition providing significant protection against many illnesses for term and preterm infants.
- This study seeks to investigate the possible protective role of DHA found in Breast Milk or Artificial Milk Formula that are used for feeding of Children and Infants.
- This study would examine the electronic patient record of Newborn from birth to about 2 months of age and Infants from 2 months to 1 year old as well as children from 1year to age 5 years old , feeding on Breast Milk or Artificial Milk Formula between March 2020 and October 2021 and compare their rates of Covid-19 infection, hospitalization and complications with the rates of the local age-matched background population.
- As Covid-19 is a new disease, the existing research literature on this specific topic is extremely limited, and so far this study would be the first in this area.
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 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 children are also less often infected by SARS-CoV-2 is an ongoing debate. Large epidemiological studies suggest that 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 hospitalisation, which is less often the case for children. Some studies suggest that 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 is configured as a retrospective and prospective observational study. The study will be multi-center and will involve all Infants and Children feeding on breast milk or Artificial milk formula that contained on DHA.
Human milk is the best form of infant nutrition providing significant protection against many illnesses for term and preterm infants.
Docosahexaenoic acid (DHA) was detected in abundance in breast milk and other algal sources milk supplement used for newborns and children's feeding. DHA concentration in breast milk varies more than 20-fold across human populations (0.06-1.4% by weight).
Naturally, cow's milk does not provide a rich source of DHA however in most companies whole milk and partially skimmed milk (2%) are fortified with DHA by adding DHA rich feed additive to Market milk formula. Therefore, we will take a cohort of children and infants who feed on natural cow's milk without any processing not breast milk or Artificial milk formula contained on DHA additive as a control.
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. Therefore, we will take a cohort of adults who did not feed on any Artificial milk formula contained on DHA additive as a control.
This study seeks to investigate the possible protective role of DHA found in Breast Milk or Artificial Milk Formula that are used for feeding of Children and Infants.
This study would examine the electronic patient record of Newborn from birth to about 2 months of age and Infants from 2 months to 1 year old as well as children from 1year to age 5 years old , feeding on Breast Milk or Artificial Milk Formula between March 2020 and October 2021 and compare their rates of Covid-19 infection, hospitalization and complications with the rates of the local age-matched background population.
As Covid-19 is a new disease, the existing research literature on this specific topic is extremely limited, and so far this study would be the first in this area.
- Conditions
- COVID19
- Medical subject headings
- COVID-19
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 |
|---|---|---|
| 300 Newborn feeding on Breast Milk or Artificial Milk Formula rom birth to about 2 months of age | The electronic patient record of 300 Newborn feeding on Breast Milk or Artificial Milk Formula from birth to about 2 months of age would be examined and followed between March 2020 and October 2021 and compare their rates of Covid-19 infection, hospitalization and complications with the rates of the Control Groups | |
| 300 Infant feeding on Breast Milk or Artificial Milk Formula from 2 months to 1 year | The electronic patient record of 300 Infant feeding on Breast Milk or Artificial Milk Formula from 2 months to 1 year would be examined and followed between March 2020 and October 2021 and compare their rates of Covid-19 infection, hospitalization and complications with the rates of the rates of the Control Groups | |
| 300 child feeding on Breast Milk or Artificial Milk Formula from 1 year to 5 year | The electronic patient record of 300 child feeding on Breast Milk or Artificial Milk Formula from 1 year to 5 year would be examined and followed between March 2020 and October 2021 and compare their rates of Covid-19 infection, hospitalization and complications with the rates of the rates of the Control Groups | |
| 300 child feeding on Breast Milk or Artificial Milk Formula from 5 year up to 15 year | The electronic patient record of 300 child feeding on Artificial Milk Formula or any source of DHA from 5 year up to 15 year would be examined and followed between March 2020 and October 2021 and compare their rates of Covid-19 infection, hospitalization and complications with the rates of the Control Groups | |
| Control Group | 1. The electronic patient record of 150 infant and child patients who feed on only cow's milk which does not provide a rich source of DHA and did not feed on any Artificial Milk Formula or any source of DHA would be examined and followed between March 2020 and October 2021 and compare their rates of Covid-19 infection, hospitalization and complications with the rates of the cohorts that feed on Breast Milk or Artificial Milk Formula 2. The electronic patient record of 150 adult patients from 15 years to 25 years who did not feed on any Artificial Milk Formula or any source of DHA would be examined and followed between March 2020 and October 2021 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Susceptibility for COVID-19.
Did infants and children who were fed breast milk or artificial milk formula have a lower risk of infection with Covid-19? in comparison with the control groups
Measured: March2020 - October 2021
Secondary outcomes (6)
Severity for COVID-19.
Did infants and children with COVID-19 who were fed breast milk or artificial milk formula have a lower chance of illness severity and requiring intensive care support or not in comparison with the control groups, ?
Measured: March2020 - October 2021
Mortality
In comparison to the control groups, did newborns and children with COVID-19 who were fed breast milk or artificial milk formula have a reduced mortality rate?
Measured: March2020 - October 2021
Care and Critical Care
Did infants and children with COVID-19 feeding on Breast Milk or Artificial Milk Formula have a shorter Length of hospitalization and stay in the ICU in comparison with the control groups
Measured: March2020 - October 2021
Resolution of fever
In comparison to the control groups, did COVID-19-infected infants and children who were fed breast milk or artificial milk formula have a faster resolution of fever and did not require advanced fever management?
Measured: March2020 - October 2021
Percentage of children requiring intensive care support
Measured: March2020 - October 2021
Clinical symptoms of children
Measured: March2020 - October 2021
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2021
- Study startDec 2021 (estimated)
- Primary completionJan 2022 (estimated)
- Study completionFeb 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID19Studies of the same condition, open and under way.
- More trials run by Kafrelsheikh UniversityThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 1,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kafrelsheikh University
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Health, Saudi Arabia
- Responsible party
- Principal investigator, Mahmoud Ramadan mohamed Elkazzaz, Kafrelsheikh University
- Investigators
- Dr Mahmoud R Elkazzaz, M.Sc of Biochemistry, Principal investigator, Faculty of Science Damietta UniversityDr Amr K Ahmed, Principal investigator, Ministry of Health, Saudi Arabia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05075031
- Sponsor's protocol ID
- Observational COVID-19 Study
- Status last verified
- Oct 2021
- First submitted
- 6 Oct 2021
- Last updated
- 12 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 12 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Could Docosahexaenoic Acid (DHA), Contained in Breast Milk and Artificial Baby Milks, Protect Infants and Children From COVID-19 and Make Them Less Prone to COVID-19-related Severe Illness Than Adults?
- ClinicalTrials.gov ID
- NCT05075031
- Acronym / sponsor ID
- Observational COVID-19 Study
- Conditions
- COVID19
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,500 participants (estimated)
- Lead sponsor
- Kafrelsheikh UniversityUniversity, hospital or other
- Collaborators
- Ministry of Health, Saudi Arabia
- Study start
- Dec 2021 (estimated)
- Primary completion
- Jan 2022 (estimated)
- Study completion
- Feb 2022 (estimated)
- First posted
- 12 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.
Could Docosahexaenoic Acid (DHA) Protect Infants and Children From COVID-19 and Make Them Less Susceptible to COVID-19-related Severe Illness Than Adults?
- The study is configured as a retrospective and prospective observational study. The study will be multi-center and will involve all Infants and Children feeding on breast milk or Artificial milk formula that contained on DHA.
- Human milk is the best form of infant nutrition providing significant protection against many illnesses for term and preterm infants.
- This study seeks to investigate the possible protective role of DHA found in Breast Milk or Artificial Milk Formula that are used for feeding of Children and Infants.
- This study would examine the electronic patient record of Newborn from birth to about 2 months of age and Infants from 2 months to 1 year old as well as children from 1year to age 5 years old , feeding on Breast Milk or Artificial Milk Formula between March 2020 and October 2021 and compare their rates of Covid-19 infection, hospitalization and complications with the rates of the local age-matched background population.
- As Covid-19 is a new disease, the existing research literature on this specific topic is extremely limited, and so far this study would be the first in this area.
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 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 children are also less often infected by SARS-CoV-2 is an ongoing debate. Large epidemiological studies suggest that 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 hospitalisation, which is less often the case for children. Some studies suggest that 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 is configured as a retrospective and prospective observational study. The study will be multi-center and will involve all Infants and Children feeding on breast milk or Artificial milk formula that contained on DHA.
Human milk is the best form of infant nutrition providing significant protection against many illnesses for term and preterm infants.
Docosahexaenoic acid (DHA) was detected in abundance in breast milk and other algal sources milk supplement used for newborns and children's feeding. DHA concentration in breast milk varies more than 20-fold across human populations (0.06-1.4% by weight).
Naturally, cow's milk does not provide a rich source of DHA however in most companies whole milk and partially skimmed milk (2%) are fortified with DHA by adding DHA rich feed additive to Market milk formula. Therefore, we will take a cohort of children and infants who feed on natural cow's milk without any processing not breast milk or Artificial milk formula contained on DHA additive as a control.
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. Therefore, we will take a cohort of adults who did not feed on any Artificial milk formula contained on DHA additive as a control.
This study seeks to investigate the possible protective role of DHA found in Breast Milk or Artificial Milk Formula that are used for feeding of Children and Infants.
This study would examine the electronic patient record of Newborn from birth to about 2 months of age and Infants from 2 months to 1 year old as well as children from 1year to age 5 years old , feeding on Breast Milk or Artificial Milk Formula between March 2020 and October 2021 and compare their rates of Covid-19 infection, hospitalization and complications with the rates of the local age-matched background population.
As Covid-19 is a new disease, the existing research literature on this specific topic is extremely limited, and so far this study would be the first in this area.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| 300 Newborn feeding on Breast Milk or Artificial Milk Formula rom birth to about 2 months of age | – | –The electronic patient record of 300 Newborn feeding on Breast Milk or Artificial Milk Formula from birth to about 2 months of age would be examined and followed between March 2020 and October 2021 and compare their rates of Covid-19 infection, hospitalization and complications with the rates of the Control Groups |
| 300 Infant feeding on Breast Milk or Artificial Milk Formula from 2 months to 1 year | – | –The electronic patient record of 300 Infant feeding on Breast Milk or Artificial Milk Formula from 2 months to 1 year would be examined and followed between March 2020 and October 2021 and compare their rates of Covid-19 infection, hospitalization and complications with the rates of the rates of the Control Groups |
| 300 child feeding on Breast Milk or Artificial Milk Formula from 1 year to 5 year | – | –The electronic patient record of 300 child feeding on Breast Milk or Artificial Milk Formula from 1 year to 5 year would be examined and followed between March 2020 and October 2021 and compare their rates of Covid-19 infection, hospitalization and complications with the rates of the rates of the Control Groups |
| 300 child feeding on Breast Milk or Artificial Milk Formula from 5 year up to 15 year | – | –The electronic patient record of 300 child feeding on Artificial Milk Formula or any source of DHA from 5 year up to 15 year would be examined and followed between March 2020 and October 2021 and compare their rates of Covid-19 infection, hospitalization and complications with the rates of the Control Groups |
| Control Group | – | –1. The electronic patient record of 150 infant and child patients who feed on only cow's milk which does not provide a rich source of DHA and did not feed on any Artificial Milk Formula or any source of DHA would be examined and followed between March 2020 and October 2021 and compare their rates of Covid-19 infection, hospitalization and complications with the rates of the cohorts that feed on Breast Milk or Artificial Milk Formula 2. The electronic patient record of 150 adult patients from 15 years to 25 years who did not feed on any Artificial Milk Formula or any source of DHA would be examined and followed between March 2020 and October 2021 |
Who may qualify
- Ages
- 1 day to 25 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Newborn Infants and children feeding on Breast Milk or Artificial Milk Formula in the range from birth to about 15 years of age would be examined and followed between March 2020 and October 2021 and compare their rates of Covid-19 infection, hospitalization and complications with the rates of the Control Groups
Key inclusion criteria (6 listed)
- Newborn feeding on Breast Milk or Artificial Milk Formula from birth to about 2 months of age.
- Infant feeding on Breast Milk or Artificial Milk Formula from 2 months to 1 year
- Children feeding on Breast Milk or Artificial Milk Formula from 1 year to 5 year.
- Children feeding on Breast Milk or Artificial Milk Formula from 5 year up to 15 year
- Adult patients from 15 years to 25 years who did not feed on any Artificial Milk Formula or any source of DHA .
Key exclusion criteria (2 listed)
- Age above 25 years.
- Adult patients from 15 years to 25 years who feed on any Artificial Milk Formula or any source of DHA ..
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
Susceptibility for COVID-19.
Time frame: March2020 - October 2021
Did infants and children who were fed breast milk or artificial milk formula have a lower risk of infection with Covid-19? in comparison with the control groups
6 secondary outcomes
Severity for COVID-19.
Time frame: March2020 - October 2021
Mortality
Time frame: March2020 - October 2021
Care and Critical Care
Time frame: March2020 - October 2021
Resolution of fever
Time frame: March2020 - October 2021
Percentage of children requiring intensive care support
Time frame: March2020 - October 2021
Clinical symptoms of children
Time frame: March2020 - October 2021
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Oct 2021.
- Natural phytochemicals, Phenformin, and Docosahexaenoic acid (DHA) as a Novel Inhibitors of IL-6 and ACE2 receptors, a Therapeutic Strategy for targeting COVID-19 Cell Entry and Cytokine Storm. An insilico ApproachLink provided by the sponsor.
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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.
Dr Mahmoud R Elkazzaz, M.Sc of Biochemistry principal investigator
Faculty of Science Damietta University
Dr Amr K Ahmed principal investigator
Ministry of Health, Saudi Arabia
Questions about this trial
What is this clinical trial studying?
An observational study of COVID19, run by Kafrelsheikh University.
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 6 inclusion and 2 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 12 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
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 Mahmoud R Elkazzaz, M.Sc of Biochemistry (00201090302015, mahmoudramadan2051@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Susceptibility for COVID-19. (time frame: March2020 - October 2021). 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 12 Oct 2021.