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Clinical Trials in Switzerland / NCT06821802
Recruiting Not applicable

Protein Supplementation in Hyponatremia Due to the Syndrome of Inappropriate Antidiuresis

NCT06821802 · tracked via the Priya Life Science Switzerland tracker
Phase
Not applicable
Started
2025-04-14
Last updated
2025-07-10

Condition(s) studied

HyponatremiaSyndrome of Inappropriate Antidiuresis

Investigational drug(s) / intervention(s)

Moltein PURE Protein PowderFluid restriction

Moltein PURE Protein Powder: 80 g protein supplementation per day (two bottles, each containing 40 g protein)

Fluid restriction: total daily fluid intake to a maximum of 1000 ml

Study summary

The goal of this study is to assess the impact of protein supplementation on hyponatremia caused by the syndrome of inappropriate antidiuresis during hospitalization.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * Adult patients with confirmed SIAD during the hospital stay or at screening, defined by: * Plasma sodium concentration \<135 mmol/L * Plasma osmolality \<300 mOsm/kg * Urine osmolality \>100 mOsm/kg * Urine sodium concentration \>30 mmol/L * Clinical euvolemia (no signs of hypovolemia or hypervolemia) Exclusion Criteria: * Lactose intolerance, milk protein allergy, soy allergy, nuts allergy, or hypersensitivity to components of the protein supplement. * Inborn metabolic disorders affecting carbohydrate, lipid, or protein metabolism. * Severe symptomatic hyponatremia requiring 3% NaCl or intensive care. * New (within the last five days) treatment with SGLT2 inhibitors, vaptans or oral urea * Uncontrolled severe hypothyroidism (untreated) * Uncontrolled adrenal insufficiency (morning cortisol \<150nmol/l) * eGFR \<45 mL/min/1.73 m² (KDIGO G3b-5) or end-stage renal disease (dialysis) * Severe hepatic impairment or advanced symptomatic liver disease defined as past or current hepatic encephalopathy, liver cirrhosis Child C, or decompensated (bleeding, jaundice, hepatorenal syndrome) * Pregnancy, breastfeeding, or plans to become pregnant during the study. * End-of-life care * Lack of capacity or other reasons preventing from giving informed consent or following study procedures (e.g., due to language problems, psychological disorders, dementia, etc.) * Treatment with thiazid diuretic (must be stopped at least 48 hours before inclusion) Post-randomization Exclusion Criteria: * Type 1 diabetes or uncontrolled type 2 diabetes (HbA1c \>8.0%)

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
University Hospital Basel Basel Switzerland Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06821802 on ClinicalTrials.gov ↗ ← All trials in Switzerland