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

No results posted yet for this study

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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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04310319 on ClinicalTrials.gov