NCT06869603

Brief Summary

The aim of this research protocol is to evaluate the adherence to the Mediterranean diet in patients suffering from recurrent kidney stones and osteometabolic diseases. Results of the study will allow to assess the dietary habits of patients with the above diseases. Given the universal prevalence of nephrolithiasis and osteometabolic diseases, the knowledge of these data appears crucial for the proper management of the dietary approach to prophylaxis secondar

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
7mo left

Started Dec 2023

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress81%
Dec 2023Dec 2026

Study Start

First participant enrolled

December 7, 2023

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

March 25, 2024

Completed
12 months until next milestone

First Posted

Study publicly available on registry

March 11, 2025

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2025

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2026

Expected
Last Updated

March 11, 2025

Status Verified

March 1, 2025

Enrollment Period

2.1 years

First QC Date

March 25, 2024

Last Update Submit

March 10, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Patient eating habits

    Questionaries to detect the patients eating habits.

    1-36 months

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients with idiopathic relapsing nephrolithiasis with evidence instrumental of bilateral renal stones or emission of more than one stone in the past 5 years

You may qualify if:

  • Patients with idiopathic relapsing nephrolithiasis with evidence instrumental of bilateral renal stones or emission of more than one stone in the past 5 years

You may not qualify if:

  • Patients who had albumin-corrected plasma calcium levels \> 11.0 mg/dl at the time of the first determination of serum levels of 25 OH vitamin D;
  • Patients who had glomerular filtration rate \< 60 mL/min/1.73 m2;
  • Patients who had positive personal history of chronic granulomatous disease;
  • pregnancy patients;
  • Positive personal history for morphological abnormalities of the excretory system;
  • incomplete data collection.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Irccs Synlab Sdn

Naples, 80143, Italy

RECRUITING

MeSH Terms

Conditions

Nephrolithiasis

Condition Hierarchy (Ancestors)

Kidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesUrolithiasisMale Urogenital Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 25, 2024

First Posted

March 11, 2025

Study Start

December 7, 2023

Primary Completion

December 31, 2025

Study Completion (Estimated)

December 1, 2026

Last Updated

March 11, 2025

Record last verified: 2025-03

Locations