Nutcracker Syndrome, RenalNCT07868406
Body Composition, Urine Protein, and Kidney Blood Flow After Nutritional Counseling in Children With Nutcracker Syndrome
An observational study of Nutcracker Syndrome, Renal, run by Kanuni Sultan Suleyman Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial 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… Read more about this study
- Who is it for?
- Ages 0 to 18 years
- Conditions the study is for
- Nutcracker Syndrome, Renal
- What is being tested?
- Nutritional Counseling
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 96 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 30 Oct 2017to 25 Sep 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
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 0 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
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.
Who may be able to join
- 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.
Who cannot join
- Severe intellectual disability.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Istanbul Kanuni Sultan Suleyman Training and Research Hospital
Istanbul
About this study
Official title: Changes in Body Composition, Proteinuria, and Renal Doppler Parameters Following Nutritional Counseling in Children With Nutcracker Syndrome
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.
- Conditions
- Nutcracker Syndrome, Renal
- Being tested
- Nutritional Counseling
- Keywords
- Children, Proteinuria, Body Composition, Nutritional Counseling, Bioelectrical Impedance Analysis, Doppler Ultrasonography
- Medical subject headings
- Renal Nutcracker Syndrome, Proteinuria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nutritional CounselingBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Nutritional Counseling |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and 6 months
Secondary outcomes (2)
Change in Body Composition Parameters
Body composition parameters (body mass index z-score, fat mass, and fat-free mass) measured by bioelectrical impedance analysis at baseline and six months after nutritional counseling.
Measured: Baseline and 6 months
Change in Renal Doppler Parameters
Left renal vein peak velocity ratio and anteroposterior diameter ratio measured by Doppler ultrasonography at baseline and six months after nutritional counseling.
Time Frame: Baseline and 6 months
Measured: Baseline and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2026
- Study start30 Oct 2017
- Primary completion25 Sep 2018
- Study completion25 Sep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nutcracker Syndrome, RenalStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 96 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kanuni Sultan Suleyman Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kazım Okan Dolu, Kanuni Sultan Suleyman Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07868406
- Sponsor's protocol ID
- NCS-NUTRITION-01
- Status last verified
- Oct 2026
- First submitted
- 3 Oct 2026
- Last updated
- 9 Oct 2026
- Results posted
- No
- Data monitoring committee
- 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 9 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Changes in Body Composition, Proteinuria, and Renal Doppler Parameters Following Nutritional Counseling in Children With Nutcracker Syndrome
- ClinicalTrials.gov ID
- NCT07868406
- Acronym / sponsor ID
- NCS-NUTRITION-01
- Conditions
- Nutcracker Syndrome, Renal
- Keywords
- Children, Proteinuria, Body Composition, Nutritional Counseling, Bioelectrical Impedance Analysis, Doppler Ultrasonography
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 96 participants (actual)
- Lead sponsor
- Kanuni Sultan Suleyman Training and Research HospitalUniversity, hospital or other
- Study start
- 30 Oct 2017 (actual)
- Primary completion
- 25 Sep 2018 (actual)
- Study completion
- 25 Sep 2018 (actual)
- First posted
- 9 Oct 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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Children With Nutcracker Syndrome | – | Behavioral: Nutritional CounselingChildren 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. |
Who may qualify
- Ages
- 0 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- 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.
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (1 listed)
- Severe intellectual disability.
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 |
|---|---|---|
| Nutritional CounselingChildren 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. | Behavioural | Children With Nutcracker Syndrome |
Primary outcome
Change in Urinary Protein Excretion
Time frame: Baseline and 6 months
Urinary protein excretion measured in a timed urine collection and expressed in mg/m²/hour. The change from baseline to six months was assessed.
2 secondary outcomes
Change in Body Composition Parameters
Time frame: Baseline and 6 months
Change in Renal Doppler Parameters
Time frame: Baseline and 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2026.
- Individual participant dataSharing planned: No
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Chronic Headache, Nutcracker Phenomenon, Renal
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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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 Nutcracker Syndrome, Renal, run by Kanuni Sultan Suleyman Training and Research Hospital 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 2 inclusion and 1 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: finished, as of the sponsor's last update on 9 Oct 2026. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Urinary Protein Excretion (time frame: Baseline and 6 months). 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 9 Oct 2026.