This Study Evaluates the Superiority of Daily Self-pH Monitorization of Lit-control®pH Meter Compared to the Monitorization of Reactive Strips (Standard of Care).
NCT ID: NCT03539926
Last Updated: 2018-11-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
60 participants
INTERVENTIONAL
2018-04-09
2019-02-28
Brief Summary
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Detailed Description
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It is known that urinary pH is a risk factor for the formation of cystine crystals because their solubility is pH-dependent. In different studies it has been shown that the solubility of cystine in urine increases when alkalinizing urinary pH, thus reducing the likelihood of crystal formation. Therefore, the control of urinary pH along with hygienic-dietetic measures that alkalize the urine or decrease the urinary concentration of cystine (abundant intake of water, food, etc.) are highly recommended as a preventive method to prevent the formation of cystine crystals whose retention and growth results in the formation of stones.
The Lit-control®pH Meter is a pH meter that allows a patient to self-monitor its urinary pH in a comfortable and simple way. With this tool the patient is able to know if his urinary pH is within the recommended limits. In other medical fields it has been observed that home monitoring of clinically relevant physiological parameters is a way of empowering the patient that can positively affect their attitudes and behaviors (adherence to received treatment, quality of life) and potentially improve their medical condition. Specifically, in patients with chronic diseases, the self-monitoring has been associated with a significant reduction in hospitalizations and hospital readmissions.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
The proportion of patients will be 1: 1 between the study group (Lit-control®pH Meter) and the control group (test strips).
OTHER
NONE
Study Groups
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Lit-control®pH Meter
The control of the urinary pH will be carried out twice a day: with the first urine in the morning and in the evening-night (approximately every 12h and at the same time). Measurements will be performed using the Lit-control®pH Meter device.
Lit-control®pH Meter
Alkalinization products will be used as standard clinical practice together with the pH monitoring through the Lit-control®pH Meter.
Reactive strips
The control of the urinary pH will be carried out twice a day: with the first urine in the morning and in the evening-night (approximately every 12h and at the same time). Measurements will be performed using the reactive strips.
Reactive strips
Alkalinization products will be used as standard clinical practice together with the pH monitoring through the reactive strips.
Interventions
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Lit-control®pH Meter
Alkalinization products will be used as standard clinical practice together with the pH monitoring through the Lit-control®pH Meter.
Reactive strips
Alkalinization products will be used as standard clinical practice together with the pH monitoring through the reactive strips.
Eligibility Criteria
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Inclusion Criteria
* Cystinuric patients, with or without urinary lithiasis at the time of inclusion.
* Patients who accept their participation in the study and give their informed consent.
Exclusion Criteria
18 Years
ALL
No
Sponsors
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Clever Instruments S.L.
INDUSTRY
Fundacio Puigvert
OTHER
Devicare S.L.
INDUSTRY
Responsible Party
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Principal Investigators
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Oriol Angerri, MD
Role: PRINCIPAL_INVESTIGATOR
Fundacio Puigvert
Locations
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Fundacio Puigvert
Barcelona, , Spain
Countries
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Other Identifiers
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DEV-LCD-01-17
Identifier Type: -
Identifier Source: org_study_id
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