Down SyndromeDSNCT06989060
Nutritional Status in Children With Down Syndrome
An observational study of Down Syndrome, run by Assiut University at 1 site in Egypt.
Trial summary
To evaluate the nutritional status of children with Down's syndrome and to determine the prevalence of nutritional deficiencies among those children. To discuss factors associated with their nutritional status, such as dietary habits and comorbid health conditions. Read more about this study
- Who is it for?
- Ages 2 to 5 years
- Conditions the study is for
- Down Syndrome
- How many people
- 75 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jun 2025to 1 Aug 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 2 to 5 years
- All sexes
- Child
Study population: Children diagnosed with Down's syndrome Age between 2- 5 years of both sexes
Who may be able to join
- Clinical diagnosis of children with Down's syndrome Age between 2- 5 years of both sexes
Who cannot join
- Children diagnosed with any other chronic illness or any other medical problem
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Assessment of Nutritional Status and Detection of Nutritional Deficiencies in Children With Down Syndrome
To evaluate the nutritional status of children with Down's syndrome and to determine the prevalence of nutritional deficiencies among those children.
To discuss factors associated with their nutritional status, such as dietary habits and comorbid health conditions.
- Conditions
- Down Syndrome
- Medical subject headings
- Down Syndrome
What is being measured
The primary outcome is the main question the study is designed to answer.
Weight
Body weight of children with Down syndrome will be measured in kilograms using a calibrated scale by trained personnel.
Measured: Baseline
Height
Height of children with Down syndrome will be measured in centimeters using a calibrated stadiometer by trained personnel.
Measured: Baseline
Body Mass Index (BMI)
BMI will be calculated using the formula: weight (kg) divided by height in meters squared (m²). Nutritional status will be classified based on WHO Child Growth Standards (underweight, normal weight, overweight, etc.).
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2025
- Study start1 Jun 2025 (estimated)
- Primary completion1 Jun 2026 (estimated)
- Study completion1 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Down SyndromeStudies of the same condition, open and under way.
- More trials run by Assiut 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Esraa Gamal Gomaa, Assiut University
- Investigators
- Osama M Asheer, professor of pediatrics, Principal investigator, assiut university child hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06989060
- Sponsor's protocol ID
- nutritional status in DS
- Acronym
- DS
- Status last verified
- May 2025
- First submitted
- 1 Apr 2025
- Last updated
- 25 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Nutritional Status and Detection of Nutritional Deficiencies in Children With Down Syndrome
- ClinicalTrials.gov ID
- NCT06989060
- Acronym / sponsor ID
- DS / nutritional status in DS
- Conditions
- Down Syndrome
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Jun 2025 (estimated)
- Primary completion
- 1 Jun 2026 (estimated)
- Study completion
- 1 Aug 2026 (estimated)
- First posted
- 25 May 2025 (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.
To evaluate the nutritional status of children with Down's syndrome and to determine the prevalence of nutritional deficiencies among those children.
To discuss factors associated with their nutritional status, such as dietary habits and comorbid health conditions.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 2 to 5 years
- Sex
- All
- Age groups
- Child
- Study population
- Children diagnosed with Down's syndrome Age between 2- 5 years of both sexes
Key inclusion criteria (1 listed)
- Clinical diagnosis of children with Down's syndrome Age between 2- 5 years of both sexes
Key exclusion criteria (1 listed)
- Children diagnosed with any other chronic illness or any other medical problem
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
Weight
Time frame: Baseline
Body weight of children with Down syndrome will be measured in kilograms using a calibrated scale by trained personnel.
Height
Time frame: Baseline
Height of children with Down syndrome will be measured in centimeters using a calibrated stadiometer by trained personnel.
Body Mass Index (BMI)
Time frame: Baseline
BMI will be calculated using the formula: weight (kg) divided by height in meters squared (m²). Nutritional status will be classified based on WHO Child Growth Standards (underweight, normal weight, overweight, etc.).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 May 2025.
- Individual participant dataSharing planned: No
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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.
Osama M Asheer, professor of pediatrics principal investigator
assiut university child hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Down Syndrome, run by Assiut University at 1 site in Egypt.
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: opening soon, as of the sponsor's last update on 25 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Esraa G Gomaa, master degree (+2001069932021, esraag63@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Weight (time frame: Baseline). The study lists 3 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 25 May 2025.