Plasma Copeptin in Response to Oral Urea in Healthy Adults and Patients With Polyuria-polydipsia Syndrome
NCT05890690 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 48
Last updated 2024-07-09
Summary
The aim of this study is to investigate whether oral urea stimulates copeptin release and, if so, whether it may provide a novel diagnostic test in the differentiation between AVP-D (Arginine vasopressin deficiency) and PP (primary polydipsia).
Conditions
- Arginine Vasopressin Deficiency
- Primary Polydipsia
Interventions
- DIAGNOSTIC_TEST
-
Urea
Diagnostic test with a single weight-adapted dose of oral urea dissolved in 200 ml water together with 5 g of lemon-lime flavor powder (containing maltodextrin and citric acid). The investigators will make use of the lemon-lime flavor to soften the bitter taste of urea. \- Dose calculation: 0.5 g urea/kg body weight (rounded to no decimal places), with a minimal dose of 30g and a maximal dose of 45g.
- DIAGNOSTIC_TEST
-
Placebo
Diagnostic test with a single weight-adapted dose of placebo dissolved in 200 ml water together with 5 g of lemon-lime flavor powder (containing maltodextrin and citric acid). The placebo will contain a mixture of bitter herbal substances to mimic the taste of urea. \- Dose calculation: 22 ml of placebo containing 20 ml Ergytonyl®, 1 ml Carmol®, and 1 ml Bitter Liebe®.
Sponsors & Collaborators
-
University Hospital, Basel, Switzerland
lead OTHER
Principal Investigators
-
Mirjam Christ-Crain, Prof. · University Hospital, Basel, Switzerland
Study Design
- Allocation
- RANDOMIZED
- Purpose
- DIAGNOSTIC
- Masking
- DOUBLE
- Model
- CROSSOVER
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2023-06-02
- Primary Completion
- 2024-06-24
- Completion
- 2024-06-24
Countries
- Switzerland
Study Locations
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