Effect of Malnutrition on Liver and Spleen Stiffness in Children
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age1-18
SponsorMehmet Akif AĞIR
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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).
Disqualifiers
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 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.
Trial design
Design model
Case-control
Time perspective
Prospective
Treatments tested in this trial
Shear Wave Elastography
Diagnostic testShear 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.
Treatment groups
300 Participants
are divided into 2 treatment groupsGroup A: Malnutrition Group1 intervention
Group B: Healthy Control Group1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
At baseline (single time point assessment)2
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.
Time frame
At baselineSponsors and contacts
Click on the lead sponsor to view all of their trials.
Mehmet Akif AĞIR
Lead sponsor
Selcuk University
Sponsor institution
Source ClinicalTrials.gov