Effect of Protein Supplementation on Plasma Sodium Levels and Urinary Urea Excretion in Patients With SIAD - a Monocentric Open- Label Proof-of-concept Study -The TREASURE Study

Status: Recruiting
Location: See location...
Intervention Type: Dietary Supplement
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: No
View:

• previous documented diagnosis of chronic SIAD

• confirmed diagnosis of SIAD at screening visit defined as:

• plasma sodium concentration <135 mmol/L, measured in lithium heparin plasma

• Plasma osmolality <300 mOsm/kg

• Urine osmolality >100 mOsm/kg

• Urine sodium concentration >30mmol/l

• Clinical euvolemia, defined as an absence of signs of hypovolemia (orthostasis, tachycardia, decreased skin turgor, dry mucous membranes) or hypervolemia (edema, ascites)

Locations
Other Locations
Switzerland
University Hospital Basel, Department of Endocrinology
Recruiting
Basel
Contact Information
Primary
Mirjam Christ-Crain, Prof. Dr. med.
mirjam.christ-crain@usb.ch
+41 61 265 25 25
Backup
Sophie Monnerat, MD
sophie.monnerat@usb.ch
+41 61 328 76 08
Time Frame
Start Date: October 8, 2021
Estimated Completion Date: April 2023
Participants
Target number of participants: 17
Treatments
Other: single arm: Phase 1: protein supplementation, Phase 2: Urea
Authors
Mirjam Christ-Crain, Sophie Monnerat, Cihan Atila
Sponsors
Leads: University Hospital, Basel, Switzerland

This content was sourced from clinicaltrials.gov

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