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

October 13, 2022 updated by: Ilan Beniamin Klein, Carmel Medical Center

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

Status

Indicates the current recruitment status or the expanded access status.
Withdrawn

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
24h Urine collection results
Time Frame: 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;
Through study completion, an average of 1 year

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Weight
Time Frame: Through study completion, an average of 1 year
weight in kilograms
Through study completion, an average of 1 year
Height
Time Frame: Through study completion, an average of 1 year
Height in meters
Through study completion, an average of 1 year
BMI
Time Frame: Through study completion, an average of 1 year
Calculated BMI using the above weight and height
Through study completion, an average of 1 year
Creatinin in mg/dl
Time Frame: Through study completion, an average of 1 year
Lab results
Through study completion, an average of 1 year
Calcium in mg/dl
Time Frame: Through study completion, an average of 1 year
Lab results
Through study completion, an average of 1 year
sodium in mg/dl
Time Frame: Through study completion, an average of 1 year
Lab results
Through study completion, an average of 1 year
potassium in mg/dl
Time Frame: Through study completion, an average of 1 year
Lab results
Through study completion, an average of 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Carmel Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2021

Primary Completion (ANTICIPATED)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 1, 2022

Study Completion (ANTICIPATED)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 25, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 10, 2020

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 11, 2020

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 14, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 13, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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