Study Stopped
Logistical problems in clinic
The Impact of Nutritional Service in the Stone Clinic on the Patient Urine Collection Results
NUT1
1 other identifier
observational
N/A
1 country
1
Brief Summary
Kidney stone disease has become a common phenomenon in the US and Europe with a growing incidence of about 10%. Life style and dietary changes have a cardinal part in kidney stone prevention. Therefore it was only natural to determine the impact of the addition of a nutritionist to a stone clinic run by a urologist and a nephrologist.
Trial Health
Trial Health Score
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Started Oct 2021
1 active site
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Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 25, 2020
CompletedFirst Posted
Study publicly available on registry
September 11, 2020
CompletedStudy Start
First participant enrolled
October 1, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2022
CompletedOctober 14, 2022
October 1, 2022
11 months
August 25, 2020
October 13, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
24h Urine collection results
to follow changes in the 24 hour urine collection results that are routinely taken as part as follow up: volume in millilitres; calcium, oxalate, magnesium, phosphorus sodium and potassium in mg/day;
Through study completion, an average of 1 year
Secondary Outcomes (7)
Weight
Through study completion, an average of 1 year
Height
Through study completion, an average of 1 year
BMI
Through study completion, an average of 1 year
Creatinin in mg/dl
Through study completion, an average of 1 year
Calcium in mg/dl
Through study completion, an average of 1 year
- +2 more secondary outcomes
Study Arms (2)
Test group
100 Patients that were referred to our stone clinic for follow up with risk factors for stone recurrence like metabolic syndrome and diabetes, uric acid stones etc. In addition to seeing our urologist and nephrologist these patients will also be referred to a nutritionist in order to balance risk factors and will be followed for one year with our usual blood tests and imaging
Control group
100 Patients that were referred to our stone clinic for follow up without risk factors for stone recurrence will see our urologist and nephrologist and will be followed for one year with our usual blood tests and imaging
Interventions
The test group will be seen by a nutritionist and will receive specific dietary recommendations according to their specific comorbidities and drugs
Eligibility Criteria
Patients18 yo and older referred to out kidney stone clinic
You may qualify if:
- yo and older
- kidneys
- Kidney or ureteric stone treated surgically or conservatively
You may not qualify if:
- Single kidney
- Aberrant kidney anatomy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Carmel Lady Davis Medical Center
Haifa, Israel
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
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
August 25, 2020
First Posted
September 11, 2020
Study Start
October 1, 2021
Primary Completion
September 1, 2022
Study Completion
December 1, 2022
Last Updated
October 14, 2022
Record last verified: 2022-10