Wishing to Decrease Aquaresis in ADPKD Patients Treated With a V2Ra; the Effect of Regulating Protein and Salt
NCT04310319 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 12
Last updated 2020-11-05
Summary
This study evaluates the effect of regulating salt and protein intake on urinevolume in patients with ADPKD treated with a vasopressine V2 receptor antagonist (V2RA). The investigators hypothesize that changing sodium and protein intake will reduce V2RA-induced polyuria.
Conditions
- Polycystic Kidney, Autosomal Dominant
- ADPKD
- Autosomal Dominant Polycystic Kidney
Interventions
- DIETARY_SUPPLEMENT
-
Sodiumchloride
Subjects will receive 4 capsules containting 750 NaCl each 2dd, making a total of 6 grams NaCl per day.
- DIETARY_SUPPLEMENT
-
Protein
Subjects will receive 2dd 40 ml of a protein beverage containing 0.5 grams of protein per ml, making a total of 40 grams of protein per day.
- DIETARY_SUPPLEMENT
-
Placebo comparator (salt)
Subjects will receive 4 placebo capsules (identical to salt capsules) 2dd.
- DIETARY_SUPPLEMENT
-
Placebo comparator (protein)
Subjects will receive 2dd 40 ml of placebo beverage (identical to protein beverage).
Sponsors & Collaborators
-
Esther Meijer
lead OTHER
Principal Investigators
-
Esther Meijer, Dr. · Universitar Medical Centre Groningen
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- TRIPLE
- Model
- CROSSOVER
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2020-09-07
- Primary Completion
- 2021-09-30
- Completion
- 2021-10-31
Countries
- Netherlands
Study Locations
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