Effect of Protein Supplementation on Plasma Sodium Levels and Urinary Urea Excretion in Patients ⦠(NCT04987385) | Clinical Trial Compass
CompletedNot Applicable
Effect of Protein Supplementation on Plasma Sodium Levels and Urinary Urea Excretion in Patients With SIAD
Switzerland18 participantsStarted 2021-10-08
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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)
Exclusion Criteria:
* 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 ProteinĀ®, foodspring GmbH, Germany or Clear Whey IsolateĀ®, MyProtein THG Company, United Kingdom)
* inborn metabolic disorders implying carbohydrate, lipid or protein metabolism - severe symptomatic hyponatremia in need of treatment with 3% NaCl-solution or in need of intensive/intermediate care treatment at time of inclusion
* 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 impairmā¦
What they're measuring
1
Change in plasma sodium concentration, (mmol/l)
Timeframe: from baseline to 7 days after protein supplementation (7 days)