The Impact of Nutritional Service in the Stone Clinic on the Patient Urine Collection Results (NUT1)

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

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.

Study Overview

• Status: Withdrawn
• Conditions: Kidney Calculi; Kidney Stone
• Intervention / Treatment: Behavioral: Dietary recommendations

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 Type: Observational

Contacts and Locations

Study Locations

• Israel
  • Haifa, Israel
    • Carmel Lady Davis Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 99 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients18 yo and older referred to out kidney stone clinic

Description

Inclusion Criteria:

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

Exclusion Criteria:

• Single kidney
• Aberrant kidney anatomy

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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	Behavioral: Dietary recommendations; The test group will be seen by a nutritionist and will receive specific dietary recommendations according to their specific comorbidities and drugs
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: Carmel Medical Center

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): October 1, 2021
• Primary Completion (ANTICIPATED): September 1, 2022
• Study Completion (ANTICIPATED): December 1, 2022

Study Registration Dates

• First Submitted: August 25, 2020
• First Submitted That Met QC Criteria: September 10, 2020
• First Posted (ACTUAL): September 11, 2020

Study Record Updates

• Last Update Posted (ACTUAL): October 14, 2022
• Last Update Submitted That Met QC Criteria: October 13, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Keywords: kidney stone; kidney Caliculi
• Additional Relevant MeSH Terms: Kidney Diseases; Urologic Diseases; Pathological Conditions, Anatomical; Urolithiasis; Urinary Calculi; Calculi; Kidney Calculi; Nephrolithiasis
• Other Study ID Numbers: CMC-20-0013-CTIL

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No