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

Kidney Stone Clinical Trial

— NUT1  

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04545528
• Other study ID #: CMC-20-0013-CTIL
• Status: Withdrawn
• Start date: October 1, 2021
• Est. completion date: December 1, 2022

Study information

• Verified date: October 2022
• Source: Carmel Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 1, 2022
• Est. primary completion date: September 1, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

Inclusion Criteria:

• 18 yo and older

• 2 kidneys

• Kidney or ureteric stone treated surgically or conservatively

Exclusion Criteria:

• Single kidney

• Aberrant kidney anatomy

Related Conditions & MeSH terms

• Calculi
• Kidney Calculi
• Kidney Stone
• Nephrolithiasis

Intervention

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

Locations

Country	Name	City	State
Israel	Carmel Lady Davis Medical Center	Haifa

Sponsors (1)

Lead Sponsor	Collaborator
Carmel Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

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