Malnutrition in ChildrenSWENCT06932445
Effect of Malnutrition on Liver and Spleen Stiffness in Children
An observational study of Malnutrition in Children and Liver Stiffness, run by Mehmet Akif AĞIR at 1 site in Turkey (Türkiye).
Trial summary
This prospective observational study aims to evaluate the effect of malnutrition on liver and spleen stiffness in children using shear wave elastography. Two groups of participants will be enrolled: children diagnosed with malnutrition and age-matched healthy controls. Read more about this study
- Who is it for?
- Ages 1 month to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Malnutrition in Children, Liver Stiffness, Spleen Stiffness
- What is being tested?
- Shear Wave Elastography
- How many people
- 300 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 Apr 2025to 20 May 2025
- 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 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: This study will include children aged 6 to 18 years, divided into two groups: 1. Malnutrition group: Children diagnosed with malnutrition according to World Health Organization (WHO) criteria. 2. Healthy control group: Age- and sex-matched healthy children with no known chronic illnesses. Both groups will undergo shear wave elastography to measure liver and spleen stiffness.
Who may be able to join
- Children aged 6 to 18 years.
- Diagnosis of malnutrition based on World Health Organization (WHO) criteria (for malnutrition group).
- Healthy children without any chronic illness (for control group).
Who cannot join
- Children with chronic diseases (e.g., liver disease, diabetes, immunocompromised conditions).
- Children who have previously undergone liver or spleen surgery.
- Children with inability to cooperate during elastography measurement.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Selçuk University Faculty of Medicine
Konya, Konya, 42130
Mehmet Akif AGIR, MD, +905052910809, mehmetakif_68@hotmail.com
Mehmet Akif AGIR, MD
About this study
Official title: Impact of Malnutrition on Liver and Spleen Stiffness in Children Evaluated by Shear Wave Elastography
This prospective observational study aims to evaluate the effect of malnutrition on liver and spleen stiffness in children using shear wave elastography. Two groups of participants will be enrolled: children diagnosed with malnutrition and age-matched healthy controls. Organ stiffness measurements will be compared between the two groups to assess the impact of malnutrition on liver and spleen tissue properties.
Read the detailed description
This is a prospective observational study designed to investigate the effect of malnutrition on liver and spleen stiffness in children. The study will include two groups: children diagnosed with malnutrition according to WHO criteria, and age- and sex-matched healthy controls without any known chronic illness.
All participants will undergo shear wave elastography (SWE) to measure liver and spleen stiffness using standardized ultrasound protocols. Measurements will be performed by a pediatric radiologist blinded to the nutritional status of the participants.
The primary objective is to compare organ stiffness values between malnourished children and healthy controls. Secondary analyses will explore correlations between severity of malnutrition and stiffness values. The study aims to provide non-invasive insights into early organ-level changes associated with pediatric malnutrition.
- Being tested
- Shear Wave Elastography
- Keywords
- Malnutrition, Liver Stiffness, Spleen Stiffness, Shear Wave Elastography, Children
- Medical subject headings
- Child Nutrition Disorders, Malnutrition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Shear Wave ElastographyDiagnostic test
Also called SWE
Shear wave elastography will be used to measure liver and spleen stiffness in all participants. The procedure will be performed using standard ultrasound-based elastography protocols by a pediatric radiologist.
| Study group | Role | What they receive |
|---|---|---|
| Malnutrition Group | Children diagnosed with malnutrition based on World Health Organization (WHO) criteria. Participants in this group will undergo shear wave elastography to evaluate liver and spleen stiffness. Receives: Diagnostic Test: Shear Wave Elastography | |
| Healthy Control Group | Age- and sex-matched healthy children with no known chronic diseases. These participants will also undergo shear wave elastography to allow comparison of organ stiffness values with the malnutrition group. Receives: Diagnostic Test: Shear Wave Elastography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Liver stiffness value (kPa)
Liver stiffness will be measured in kilopascals (kPa) using shear wave elastography. The average of three valid measurements will be recorded for each participant.
Measured: At baseline (single time point assessment)
Spleen stiffness value (kPa)
Spleen stiffness will be measured in kilopascals (kPa) using shear wave elastography. Similar to liver, the average of three valid measurements will be used.
Measured: At baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2025
- Study start10 Apr 2025
- Primary completion15 May 2025 (estimated)
- Study completion20 May 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Malnutrition in ChildrenStudies of the same condition, open and under way.
- 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-control
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mehmet Akif AĞIR
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Mehmet Akif AĞIR, Selcuk University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06932445
- Sponsor's protocol ID
- 2025/201
- Acronym
- SWE
- Status last verified
- Apr 2025
- First submitted
- 10 Apr 2025
- Last updated
- 17 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The individual participant data will be shared upon request with qualified researchers, subject to institutional review and approval. Data sharing will be conducted in accordance with the university's data protection policies.
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Malnutrition on Liver and Spleen Stiffness in Children Evaluated by Shear Wave Elastography
- ClinicalTrials.gov ID
- NCT06932445
- Acronym / sponsor ID
- SWE / 2025/201
- Keywords
- Malnutrition, Liver Stiffness, Spleen Stiffness, Shear Wave Elastography, Children
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Mehmet Akif AĞIRUniversity, hospital or other
- Study start
- 10 Apr 2025 (actual)
- Primary completion
- 15 May 2025 (estimated)
- Study completion
- 20 May 2025 (estimated)
- First posted
- 17 Apr 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.
This prospective observational study aims to evaluate the effect of malnutrition on liver and spleen stiffness in children using shear wave elastography. Two groups of participants will be enrolled: children diagnosed with malnutrition and age-matched healthy controls. Organ stiffness measurements will be compared between the two groups to assess the impact of malnutrition on liver and spleen tissue properties.
Detailed description
This is a prospective observational study designed to investigate the effect of malnutrition on liver and spleen stiffness in children. The study will include two groups: children diagnosed with malnutrition according to WHO criteria, and age- and sex-matched healthy controls without any known chronic illness.
All participants will undergo shear wave elastography (SWE) to measure liver and spleen stiffness using standardized ultrasound protocols. Measurements will be performed by a pediatric radiologist blinded to the nutritional status of the participants.
The primary objective is to compare organ stiffness values between malnourished children and healthy controls. Secondary analyses will explore correlations between severity of malnutrition and stiffness values. The study aims to provide non-invasive insights into early organ-level changes associated with pediatric malnutrition.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Malnutrition Group | – | Diagnostic Test: Shear Wave ElastographyChildren diagnosed with malnutrition based on World Health Organization (WHO) criteria. Participants in this group will undergo shear wave elastography to evaluate liver and spleen stiffness. |
| Healthy Control Group | – | Diagnostic Test: Shear Wave ElastographyAge- and sex-matched healthy children with no known chronic diseases. These participants will also undergo shear wave elastography to allow comparison of organ stiffness values with the malnutrition group. |
Who may qualify
- Ages
- 1 month to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- This study will include children aged 6 to 18 years, divided into two groups: 1. Malnutrition group: Children diagnosed with malnutrition according to World Health Organization (WHO) criteria. 2. Healthy control group: Age- and sex-matched healthy children with no known chronic illnesses. Both groups will undergo shear wave elastography to measure liver and spleen stiffness.
Key inclusion criteria (3 listed)
- Children aged 6 to 18 years.
- Diagnosis of malnutrition based on World Health Organization (WHO) criteria (for malnutrition group).
- Healthy children without any chronic illness (for control group).
Key exclusion criteria (3 listed)
- Children with chronic diseases (e.g., liver disease, diabetes, immunocompromised conditions).
- Children who have previously undergone liver or spleen surgery.
- Children with inability to cooperate during elastography measurement.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Shear Wave ElastographyAlso: SWEShear wave elastography will be used to measure liver and spleen stiffness in all participants. The procedure will be performed using standard ultrasound-based elastography protocols by a pediatric radiologist. | Diagnostic test | Healthy Control Group, Malnutrition Group |
Primary outcome
Liver stiffness value (kPa)
Time frame: At baseline (single time point assessment)
Liver stiffness will be measured in kilopascals (kPa) using shear wave elastography. The average of three valid measurements will be recorded for each participant.
Spleen stiffness value (kPa)
Time frame: At baseline
Spleen stiffness will be measured in kilopascals (kPa) using shear wave elastography. Similar to liver, the average of three valid measurements will be used.
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 17 Apr 2025.
- Individual participant dataSharing planned: Yes. The individual participant data will be shared upon request with qualified researchers, subject to institutional review and approval. Data sharing will be conducted in accordance with the university's data protection policies.
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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.
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 Malnutrition in Children and Liver Stiffness, run by Mehmet Akif AĞIR at 1 site in Turkey (Türkiye).
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 3 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: looking for participants now, as of the sponsor's last update on 17 Apr 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 Turkey (Türkiye). 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 Mehmet Akif AGIR, Medical Doctor (+905052910809, mehmetakif_68@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Liver stiffness value (kPa) (time frame: At baseline (single time point assessment)). The study lists 2 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 17 Apr 2025.