Kidney StoneNUT1NCT04545528
The Impact of Nutritional Service in the Stone Clinic on the Patient Urine Collection Results
An observational study of Kidney Stone and Kidney Calculi, run by Carmel Medical Center at 1 site in Israel.
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. Read more about this study
- Who is it for?
- Ages 18 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Kidney Stone, Kidney Calculi
- What is being tested?
- Dietary recommendations
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 0 participants
- Where
- 1 siteIsrael
- Study dates
- 1 Oct 2021to 1 Dec 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients18 yo and older referred to out kidney stone clinic
Who may be able to join
- 18 yo and older
- 2 kidneys
- Kidney or ureteric stone treated surgically or conservatively
Who cannot join
- Single kidney
- Aberrant kidney anatomy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Kidney Stone, Kidney Calculi
- Being tested
- Dietary recommendations
- Keywords
- kidney stone, kidney Caliculi
- Medical subject headings
- Kidney Calculi
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dietary recommendationsBehavioural
The test group will be seen by a nutritionist and will receive specific dietary recommendations according to their specific comorbidities and drugs
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Behavioral: Dietary recommendations | |
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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;
Measured: Through study completion, an average of 1 year
Secondary outcomes (7)
Weight
weight in kilograms
Measured: Through study completion, an average of 1 year
Height
Height in meters
Measured: Through study completion, an average of 1 year
BMI
Calculated BMI using the above weight and height
Measured: Through study completion, an average of 1 year
Creatinin in mg/dl
Lab results
Measured: Through study completion, an average of 1 year
Calcium in mg/dl
Lab results
Measured: Through study completion, an average of 1 year
sodium in mg/dl
Lab results
Measured: Through study completion, an average of 1 year
potassium in mg/dl
Lab results
Measured: Through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2020
- Study start1 Oct 2021 (estimated)
- Primary completion1 Sep 2022 (estimated)
- Study completion1 Dec 2022 (estimated)
Why it stopped: Logistical problems in clinic
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney StoneStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Carmel Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ilan Beniamin Klein, Carmel Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04545528
- Sponsor's protocol ID
- CMC-20-0013-CTIL
- Acronym
- NUT1
- Status last verified
- Oct 2022
- First submitted
- 25 Aug 2020
- Last updated
- 14 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Nutritional Service in the Stone Clinic on the Patient Urine
- ClinicalTrials.gov ID
- NCT04545528
- Acronym / sponsor ID
- NUT1 / CMC-20-0013-CTIL
- Conditions
- Kidney Stone, Kidney Calculi
- Keywords
- kidney stone, kidney Caliculi
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Logistical problems in clinic
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Carmel Medical CenterUniversity, hospital or other
- Study start
- 1 Oct 2021 (estimated)
- Primary completion
- 1 Sep 2022 (estimated)
- Study completion
- 1 Dec 2022 (estimated)
- First posted
- 11 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Test group | – | Behavioral: Dietary recommendations100 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 |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients18 yo and older referred to out kidney stone clinic
Key inclusion criteria (3 listed)
- 18 yo and older
- 2 kidneys
- Kidney or ureteric stone treated surgically or conservatively
Key exclusion criteria (2 listed)
- Single kidney
- Aberrant kidney anatomy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dietary recommendationsThe test group will be seen by a nutritionist and will receive specific dietary recommendations according to their specific comorbidities and drugs | Behavioural | Test group |
Primary outcome
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;
7 secondary outcomes
Weight
Time frame: Through study completion, an average of 1 year
Height
Time frame: Through study completion, an average of 1 year
BMI
Time frame: Through study completion, an average of 1 year
Creatinin in mg/dl
Time frame: Through study completion, an average of 1 year
Calcium in mg/dl
Time frame: Through study completion, an average of 1 year
sodium in mg/dl
Time frame: Through study completion, an average of 1 year
potassium in mg/dl
Time frame: Through study completion, an average of 1 year
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2022.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Kidney Stone and Kidney Calculi, run by Carmel Medical Center at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 14 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
24h Urine collection results (time frame: Through study completion, an average of 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Oct 2022.