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

NCT04987385 | Completed

• 1 other identifier: 2021-01116; kt21ChristCrain2
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief 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)

Keywords

protein supplementation; plasma sodium level; hyponatremia; urea

Outcome Measures

Primary Outcomes (1)

• Change in plasma sodium concentration, (mmol/l)

  The change of blood sodium during protein supplementation regimen will be visualized by means of line plots and boxplots for patients with chronic SIAD.

  from baseline to 7 days after protein supplementation (7 days)

Secondary Outcomes (19)

• Change in estimated glomerular filtration rate (eGFR), (ml/min/1,73m2)

  from baseline to 7 days after urea supplementation (up to 21 days)

• Change in blood and urine osmolality, (mOsm/kg)

  from baseline to 7 days after urea supplementation (up to 21 days)

• Change in blood and urine potassium, (mmol/L)

  from baseline to 7 days after urea supplementation (up to 21 days)

• Change in blood and urine creatinine, (umol/L)

  from baseline to 7 days after urea supplementation (up to 21 days)

• Change in blood and urine urea, (mmol/L)

  from baseline to 7 days after urea supplementation (up to 21 days)

Study Arms (1)

single arm: Phase 1: protein supplementation, Phase 2: Urea

OTHER

Dietary Supplement: Protein supplementation; Dietary Supplement: Oral urea

Interventions

Protein supplementation DIETARY_SUPPLEMENT

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.

single arm: Phase 1: protein supplementation, Phase 2: Urea

Oral urea DIETARY_SUPPLEMENT

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.

single arm: Phase 1: protein supplementation, Phase 2: Urea

Eligibility Criteria

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

You may qualify if:

• 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)

You may not qualify if:

• lactose intolerance, celiac disease, milk protein allergy, soja allergy, nuts allergy or known hypersensitivity or allergy to one of the components of the protein supplementation (Whey Protein®, foodspring GmbH, Germany or Clear Whey Isolate®, MyProtein THG Company, United Kingdom)
• Risk factors for osmotic demyelination syndrome: hypokalaemia (K \<3,4 mmol/L), malnutrition, advanced liver disease, alcoholism.
• contraindication for lowering blood pressure
• type 1 diabetes mellitus
• uncontrolled type 2 diabetes mellitus (defined as HbA1c \>8.0%)
• uncontrolled hypothyroidism
• uncontrolled adrenal insufficiency
• reduction of eGFR \<60 mL/min/1,73 m2 (KDIGO G3, G4 and G5) or end stage renal disease (dialysis)
• severe hepatic impairment (ALAT/ASAT \>3x upper limit) or advanced symptomatic liver disease defined as past or current hepatic encephalopathy, liver cirrhosis Child C or decompensated (bleeding, jaundice, hepatorenal syndrome).
• treatment with a diuretic, a SGLT2 inhibitor or a corresponding combined preparation, lithium chloride, urea, vaptans, demeclocycline in the two weeks before screening.
• severe immunosuppression defined as leucocytes \<2G
• pregnancy, wish to become pregnant during study period or breastfeeding
• end of life care
• Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc.
• Current participation in another intervention study

Sponsors & Collaborators

• University Hospital, Basel, Switzerland: lead

Study Sites (1)

University Hospital Basel, Department of Endocrinology

Basel, 4031, Switzerland

Location

MeSH Terms

Conditions

Inappropriate ADH Syndrome; Hyponatremia

Interventions

Urea

Condition Hierarchy (Ancestors)

Pituitary Diseases; Hypothalamic Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Water-Electrolyte Imbalance; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Amides; Organic Chemicals

Study Officials

• Mirjam Christ-Crain, Prof. Dr. med.

  Universitätsspital Basel, Endokrinologie, Diabetologie und Metabolismus

  PRINCIPAL INVESTIGATOR

Study Design

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

Model Details: proof-of-concept study, no control group needed since patients serve as their own control in the second treatment phase

Study Record Dates

• First Submitted: July 21, 2021
• First Posted: August 3, 2021
• Study Start: October 8, 2021
• Primary Completion: February 20, 2023
• Study Completion: February 20, 2023
• Last Updated: February 21, 2023

Record last verified: 2023-02

Locations

CH (1)