Protein Supplementation in Hyponatremia Due to the Syndrome of Inappropriate Antidiuresis

NCT06821802 | Recruiting DMC

• 1 other identifier: 2024-02282; kt25ChristCrain2
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Hyponatremia; Syndrome of Inappropriate Antidiuresis

Keywords

dysregulated arginine vasopressin (AVP) secretion; increased renal AVP sensitivity; protein supplementation; fluid restriction

Outcome Measures

Primary Outcomes (1)

• Acceptability of Intervention Measure (AIM) questionnaire

  Treatment acceptability is assessed using the Acceptability of Intervention Measure (AIM) questionnaire, a validated patient-reported outcome measure scored on a 1 to 5 Likert scale. The total AIM score ranges from 4 to 20, with higher scores indicating greater acceptability. The primary analysis will compare AIM scores between the two treatment groups at the end of the intervention (day 5 or discharge).

  On day 5 (or discharge)

Secondary Outcomes (18)

• Plasma sodium levels

  Daily measurements from the day of inclusion to day 5

• Estimated glomerular filtration rate (eGFR)

  On the day of inclusion and on day 5

• Changes in blood electrolytes

  On the day of inclusion and on day 5

• Changes in urine electrolytes

  On the day of inclusion and on day 5

• Changes in glucose levels

  On the day of inclusion and on day 5

Study Arms (2)

Protein Supplementation

EXPERIMENTAL

80 g protein supplementation per day (two bottles, each containing 40 g protein)

Dietary Supplement: Moltein PURE Protein Powder

Fluid restriction

ACTIVE COMPARATOR

total daily fluid intake to a maximum of 1000 ml

Behavioral: Fluid restriction

Interventions

Moltein PURE Protein Powder DIETARY_SUPPLEMENT

80 g protein supplementation per day (two bottles, each containing 40 g protein)

Protein Supplementation

Fluid restriction BEHAVIORAL

total daily fluid intake to a maximum of 1000 ml

Fluid restriction

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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.)
• Type 1 diabetes or uncontrolled type 2 diabetes (HbA1c \>8.0%)

Sponsors & Collaborators

• University Hospital, Basel, Switzerland: lead

Study Sites (1)

University Hospital Basel

Basel, 4031, Switzerland

RECRUITING

MeSH Terms

Conditions

Hyponatremia; Inappropriate ADH Syndrome; Diabetes Insipidus

Condition Hierarchy (Ancestors)

Water-Electrolyte Imbalance; Metabolic Diseases; Nutritional and Metabolic Diseases; Pituitary Diseases; Hypothalamic Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Endocrine System Diseases; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• Mirjam Christ-Crain, Prof. MD

  Universitätsspital Basel

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mirjam Christ-Crain, Prof. MD

CONTACT

+41 61 328 70 80; mirjam.christ-crain@usb.ch

Cemile Bathelt

CONTACT

+41 61 556 54 07; cemile.bathelt@usb.ch

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 30, 2025
• First Posted: February 12, 2025
• Study Start: April 14, 2025
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): April 1, 2027
• Last Updated: July 10, 2025

Record last verified: 2025-07

Locations

CH (1)