Gaucher DiseaseNCT07845188
Nutritional Status of Gaucher Disease Patients
An observational study of Gaucher Disease, run by Assiut University.
Trial 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. Read more about this study
- Who is it for?
- Ages 1 month and older
- Conditions the study is for
- Gaucher Disease
- How many people
- 84 participants
- Where
- No sites listed yet
- Study dates
- 26 Sep 2026to 25 Feb 2028
- 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 1 month and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with confirmed Gaucher disease attending Assiut University Children's Hospital for follow-up visits.
Who may be able to join
- 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
Who cannot join
- Other autosomal recessive lysosomal storage diseases
- Not undergoing a follow-up visit at Assiut University Children's Hospital
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Evaluation of the Nutritional Status of Gaucher's Disease Patients
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.
Read the detailed description
Gaucher disease is a lysosomal storage disorder that may affect growth and nutritional status, particularly in children. This observational study will include patients with confirmed Gaucher disease (types 1, 2, and 3) who attend follow-up visits at Assiut University Children's Hospital.
Nutritional status will be assessed by detailed dietary history, anthropometric measurements (weight, height, BMI, mid-arm circumference), and body composition analysis using bioelectrical impedance analysis (BIA).
- Conditions
- Gaucher Disease
- Keywords
- Gaucher disease, Nutritional status, Body composition, Anthropometry, Assiut
- Medical subject headings
- Gaucher Disease
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 |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of underweight
Proportion of patients with weight-for-age below -2 standard deviations according to WHO growth charts.
Measured: Baseline
Secondary outcomes (5)
Prevalence of stunting
Proportion of patients with height-for-age below -2 standard deviations according to WHO growth charts.
Measured: Baseline
Mean body mass index
Mean body mass index (BMI) in kg/m².
Measured: Baseline
Mean mid-arm circumference
Mean mid-upper arm circumference in centimeters.
Measured: Baseline
Mean fat mass percentage
Mean fat mass percentage measured by bioelectrical impedance analysis (BIA).
Measured: Baseline
Mean lean body mass
Mean lean body mass measured by bioelectrical impedance analysis (BIA).
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2026
- Study start26 Sep 2026 (estimated)
- Primary completion26 Sep 2027 (estimated)
- Study completion25 Feb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gaucher DiseaseStudies 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
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 84 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Salma Hassanein Salem Ahmed, Assiut University
- Investigators
- Mostafa M Embaby, prof, Study chair, Pediatrics Department, Assiut University Hospitals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07845188
- Sponsor's protocol ID
- Gaucher-Nutrition-Assiut-2026
- Status last verified
- Sep 2026
- First submitted
- 22 Sep 2026
- Last updated
- 28 Sep 2026
- Results posted
- 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 28 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Nutritional Status of Gaucher's Disease Patients
- ClinicalTrials.gov ID
- NCT07845188
- Acronym / sponsor ID
- Gaucher-Nutrition-Assiut-2026
- Conditions
- Gaucher Disease
- Keywords
- Gaucher disease, Nutritional status, Body composition, Anthropometry, Assiut
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 84 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 26 Sep 2026 (estimated)
- Primary completion
- 26 Sep 2027 (estimated)
- Study completion
- 25 Feb 2028 (estimated)
- First posted
- 28 Sep 2026 (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.
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.
Detailed description
Gaucher disease is a lysosomal storage disorder that may affect growth and nutritional status, particularly in children. This observational study will include patients with confirmed Gaucher disease (types 1, 2, and 3) who attend follow-up visits at Assiut University Children's Hospital.
Nutritional status will be assessed by detailed dietary history, anthropometric measurements (weight, height, BMI, mid-arm circumference), and body composition analysis using bioelectrical impedance analysis (BIA).
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 1 month and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with confirmed Gaucher disease attending Assiut University Children's Hospital for follow-up visits.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- Other autosomal recessive lysosomal storage diseases
- Not undergoing a follow-up visit at Assiut University Children's Hospital
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
Prevalence of underweight
Time frame: Baseline
Proportion of patients with weight-for-age below -2 standard deviations according to WHO growth charts.
5 secondary outcomes
Prevalence of stunting
Time frame: Baseline
Mean body mass index
Time frame: Baseline
Mean mid-arm circumference
Time frame: Baseline
Mean fat mass percentage
Time frame: Baseline
Mean lean body mass
Time frame: Baseline
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 28 Sep 2026.
- 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.
Mostafa M Embaby, prof study chair
Pediatrics Department, Assiut University Hospitals
Questions about this trial
What is this clinical trial studying?
An observational study of Gaucher Disease, run by Assiut 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 3 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: opening soon, as of the sponsor's last update on 28 Sep 2026. 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?
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 Salma H Salem, Resident (+20 10 14620228, Salma.17308823@med.aun.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of underweight (time frame: Baseline). 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 28 Sep 2026; AzTrials last refreshed its copy on 7 Nov 2026.