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Effect of Protein Supplementation on Plasma Sodium Levels and Urinary Urea Excretion in Patients With SIAD

NCT04987385 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2023-02-21

No results posted yet for this study

Summary

This study aims to investigate whether a 7-day dietary high protein supplementation of 90 grams per day increases plasma sodium levels in hyponatremic patients with chronic SIAD.

Enrolled patients will receive first dietary high protein supplementation for one week. After a wash-out phase of at least one week, the patients will receive oral urea for another week.

Conditions

  • Syndrome of Inappropriate Antidiuresis (SIAD)

Interventions

DIETARY_SUPPLEMENT

Protein supplementation

Patients will receive a box with 7 sealable of 90-gram protein containers that will be dissolved in maximal 1L liquid (i.e., water or milk) that should be integrated in the usual daily hydration volume documented at baseline and taken daily for the following 7 days, while keeping their usual meal composition and usual fluid intake. A wash-out period of minimum 7 days between Protein supplementation and Oral urea will be performed.

DIETARY_SUPPLEMENT

Oral urea

Patients will receive a box with 7 30-grams urea sealable containers. The total daily oral urea dosage of 30 grams that will be dissolved in maximal 1L of a liquid of choice (water, milk, juice, …) that should be integrated in the usual daily hydration volume documented at baseline and taken daily for the following 7 days, while keeping their usual meal composition and usual fluid intake.

Sponsors & Collaborators

  • University Hospital, Basel, Switzerland

    lead OTHER

Principal Investigators

  • Mirjam Christ-Crain, Prof. Dr. med. · Universitätsspital Basel, Endokrinologie, Diabetologie und Metabolismus

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-10-08
Primary Completion
2023-02-20
Completion
2023-02-20

Countries

  • Switzerland

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 NCT04987385 on ClinicalTrials.gov