NCT07868406

Brief Summary

Nutcracker syndrome occurs when the vein carrying blood from the left kidney is compressed between nearby blood vessels. This can cause protein or blood to appear in the urine. This observational study examined changes in body composition, urine protein levels, and kidney Doppler ultrasound measurements in children with nutcracker syndrome who received nutritional counseling during conservative care. Measurements taken at the start of the study were compared with those taken six months later. The study also examined relationships between body composition, urine protein levels, and ultrasound measurements. There was no comparison group.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
96

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Oct 2017

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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 Start

First participant enrolled

October 30, 2017

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 25, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 25, 2018

Completed
8 years until next milestone

First Submitted

Initial submission to the registry

October 3, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 9, 2026

Completed
Last Updated

October 9, 2026

Status Verified

October 1, 2026

Enrollment Period

11 months

First QC Date

October 3, 2026

Last Update Submit

October 5, 2026

Conditions

Keywords

ChildrenProteinuriaBody CompositionNutritional CounselingBioelectrical Impedance AnalysisDoppler Ultrasonography

Outcome Measures

Primary Outcomes (1)

  • Change in Urinary Protein Excretion

    Urinary protein excretion measured in a timed urine collection and expressed in mg/m²/hour. The change from baseline to six months was assessed.

    Baseline and 6 months

Secondary Outcomes (2)

  • Change in Body Composition Parameters

    Baseline and 6 months

  • Change in Renal Doppler Parameters

    Baseline and 6 months

Study Arms (1)

Children With Nutcracker Syndrome

Children with a pre-existing diagnosis of nutcracker syndrome who received nutritional counseling during conservative care. Body composition, urinary protein excretion, and renal Doppler parameters were assessed at baseline and six months.

Behavioral: Nutritional Counseling

Interventions

Children and their parents received verbal and written advice on healthy nutrition, including a diet plan providing adequate calories for the child's age and sex. Dietitian-prepared brochures recommended that carbohydrates provide 45-65% of total calories, protein 10-30%, and fat 25-35%. Foods rich in omega-3 fatty acids, calcium, and iron were recommended. Participants were reassessed six months after the initial counseling.

Children With Nutcracker Syndrome

Eligibility Criteria

Age0 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Children with a pre-existing diagnosis of nutcracker syndrome attending the pediatric nephrology clinic at Istanbul Kanuni Sultan Suleyman Training and Research Hospital, Türkiye. Diagnosis had been established during routine clinical care on the basis of orthostatic proteinuria and renal Doppler findings.

You may qualify if:

  • Children with a pre-existing diagnosis of nutcracker syndrome established during routine clinical care on the basis of orthostatic proteinuria and renal Doppler findings.
  • Written informed consent from a parent or legal guardian.

You may not qualify if:

  • \- Severe intellectual disability.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istanbul Kanuni Sultan Suleyman Training and Research Hospital

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Renal Nutcracker SyndromeProteinuria

Interventions

Nutrition Assessment

Condition Hierarchy (Ancestors)

Kidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesUrination DisordersUrological ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationEpidemiologic MeasurementsPublic HealthEnvironment and Public Health

Study Design

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

Study Record Dates

First Submitted

October 3, 2026

First Posted

October 9, 2026

Study Start

October 30, 2017

Primary Completion

September 25, 2018

Study Completion

September 25, 2018

Last Updated

October 9, 2026

Record last verified: 2026-10

Data Sharing

IPD Sharing
Will not share

Locations