NCT07845188

Brief Summary

This cross-sectional study aims to evaluate the nutritional status of patients with Gaucher disease attending Assiut University Children's Hospital using anthropometric measurements and body composition analysis.

Trial Health

65
Monitor

Trial Health Score

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

Enrollment
84

participants targeted

Target at P50-P75 for all trials

Timeline
17mo left

Started Sep 2026

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 Progress2%
Sep 2026Feb 2028

First Submitted

Initial submission to the registry

September 22, 2026

Completed
4 days until next milestone

Study Start

First participant enrolled

September 26, 2026

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 28, 2026

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 26, 2027

Expected
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 25, 2028

Last Updated

September 28, 2026

Status Verified

September 1, 2026

Enrollment Period

1 year

First QC Date

September 22, 2026

Last Update Submit

September 22, 2026

Conditions

Gaucher Disease

Keywords

Gaucher diseaseNutritional statusBody compositionAnthropometryAssiut

Outcome Measures

Primary Outcomes (1)

  • Prevalence of underweight

    Proportion of patients with weight-for-age below -2 standard deviations according to WHO growth charts.

    Baseline

Secondary Outcomes (5)

  • Prevalence of stunting

    Baseline

  • Mean body mass index

    Baseline

  • Mean mid-arm circumference

    Baseline

  • Mean fat mass percentage

    Baseline

  • Mean lean body mass

    Baseline

Study Arms (1)

Single cohort: Gaucher Disease Patients

Patients with confirmed Gaucher disease (types 1, 2, and 3) who will undergo nutritional assessment including anthropometry and body composition analysis.

Eligibility Criteria

Age1 Month+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with confirmed Gaucher disease attending Assiut University Children's Hospital for follow-up visits.

You may qualify if:

  • Confirmed diagnosis of Gaucher disease (type 1, 2, or 3)
  • Undergoing a follow-up visit at Assiut University Children's Hospital
  • Written informed consent from caregivers

You may not qualify if:

  • Other autosomal recessive lysosomal storage diseases
  • Not undergoing a follow-up visit at Assiut University Children's Hospital

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Gaucher Disease

Condition Hierarchy (Ancestors)

SphingolipidosesLysosomal Storage Diseases, Nervous SystemBrain Diseases, Metabolic, InbornBrain Diseases, MetabolicBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMetabolism, Inborn ErrorsGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesLipidosesLipid Metabolism, Inborn ErrorsLysosomal Storage DiseasesMetabolic DiseasesNutritional and Metabolic DiseasesLipid Metabolism Disorders

Study Officials

  • Mostafa M Embaby, prof

    Pediatrics Department, Assiut University Hospitals

    STUDY CHAIR

Central Study Contacts

Salma H Salem, Resident

CONTACT

+20 10 14620228Salma.17308823@med.aun.edu.eg

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Resident Physician, Department of Pediatrics

Study Record Dates

First Submitted

September 22, 2026

First Posted

September 28, 2026

Study Start

September 26, 2026

Primary Completion (Estimated)

September 26, 2027

Study Completion (Estimated)

February 25, 2028

Last Updated

September 28, 2026

Record last verified: 2026-09

Data Sharing

IPD Sharing
Will not share