The Impact of Nutritional Service in the Stone Clinic on the Patient Urine Collection Results

Withdrawn

• Conditions: Kidney Stone; Kidney Calculi
• Interventions: Behavioral: Dietary recommendations

• Registration Number: NCT04545528
• Lead Sponsor: Carmel Medical Center

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.

Detailed Description

Kidney stone disease has become a common phenomenon in the US and Europe with a growing incidence of about 10%. A history of kidney stone disease has also been connected to cardiovascular and renal insufficiency events to a point that kidney stones is looked at today as a systemic predictor of hypertension, cardiovascular disease and more.

Seeing the importance of these risk factors we initiated a stone clinic for our kidney stone patients several years ago run jointly by a urologist and a nephrologist. Seeing that life style and dietary changes have a cardinal part in kidney stone prevention, 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 on our patient parameters.

Study Timeline

• Study First Submitted: 2020-08-25
• Study First Submitted QC: 2020-09-10
• Study First Posted: 2020-09-11
• Study Start: 2021-10-01
• Primary Completion: 2022-09-01
• Status Verified: 2022-10
• Last Update Submitted: 2022-10-13
• Last Update Posted: 2022-10-14
• Study Completion: 2022-12-01

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• 18 yo and older
• 2 kidneys
• Kidney or ureteric stone treated surgically or conservatively

Exclusion Criteria

• Single kidney
• Aberrant kidney anatomy

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Test group	Dietary recommendations	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

Primary Outcome Measures

Name	Time	Method
24h Urine collection results	Through study completion, an average of 1 year	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;

Secondary Outcome Measures

Name	Time	Method
BMI	Through study completion, an average of 1 year	Calculated BMI using the above weight and height
sodium in mg/dl	Through study completion, an average of 1 year	Lab results
Weight	Through study completion, an average of 1 year	weight in kilograms
Creatinin in mg/dl	Through study completion, an average of 1 year	Lab results
Calcium in mg/dl	Through study completion, an average of 1 year	Lab results
potassium in mg/dl	Through study completion, an average of 1 year	Lab results
Height	Through study completion, an average of 1 year	Height in meters

Trial Locations

Locations (1)

Carmel Lady Davis Medical Center; 🇮🇱 Haifa, Israel