NCT06989060

Brief 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.

Trial Health

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Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
75

participants targeted

Target at P50-P75 for all trials

Timeline
3mo left

Started Jun 2025

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress80%
Jun 2025Aug 2026

First Submitted

Initial submission to the registry

April 1, 2025

Completed
2 months until next milestone

First Posted

Study publicly available on registry

May 25, 2025

Completed
7 days until next milestone

Study Start

First participant enrolled

June 1, 2025

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2026

Expected
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2026

Last Updated

May 25, 2025

Status Verified

May 1, 2025

Enrollment Period

1 year

First QC Date

April 1, 2025

Last Update Submit

May 21, 2025

Conditions

Outcome Measures

Primary Outcomes (3)

  • Weight

    Body weight of children with Down syndrome will be measured in kilograms using a calibrated scale by trained personnel.

    Baseline

  • Height

    Height of children with Down syndrome will be measured in centimeters using a calibrated stadiometer by trained personnel.

    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.).

    Baseline

Eligibility Criteria

Age2 Years - 5 Years
Sexall
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

Children diagnosed with Down's syndrome Age between 2- 5 years of both sexes

You may qualify if:

  • Clinical diagnosis of children with Down's syndrome Age between 2- 5 years of both sexes

You may not qualify if:

  • Children diagnosed with any other chronic illness or any other medical problem

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Assiut university child hospital

Asyut, Egypt

Location

MeSH Terms

Conditions

Down Syndrome

Condition Hierarchy (Ancestors)

Intellectual DisabilityNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesAbnormalities, MultipleCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesChromosome DisordersGenetic Diseases, Inborn

Study Officials

  • Osama M Asheer, professor of pediatrics

    assiut university child hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Esraa G Gomaa, master degree

CONTACT

Osama M Asheer, professor

CONTACT

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

April 1, 2025

First Posted

May 25, 2025

Study Start

June 1, 2025

Primary Completion (Estimated)

June 1, 2026

Study Completion (Estimated)

August 1, 2026

Last Updated

May 25, 2025

Record last verified: 2025-05

Data Sharing

IPD Sharing
Will not share

Locations