HyponatremiaTREASURExNCT06821802
Protein Supplementation in Hyponatremia Due to the Syndrome of Inappropriate Antidiuresis
A study testing Moltein PURE Protein Powder and Fluid restriction in people with Hyponatremia and Syndrome of Inappropriate Antidiuresis, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hyponatremia, Syndrome of Inappropriate Antidiuresis
- What is being tested?
- Moltein PURE Protein Powder and Fluid restriction
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteSwitzerland
- Study dates
- 14 Apr 2025to Apr 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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)
Show all 14Show fewer
- 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%)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Switzerland1 site, 1 recruiting
- Recruiting
University Hospital Basel
Basel, 4031
Mirjam Christ-Crain, +41 61 328 70 80, mirjam.christ-crain@usb.ch
About this study
Official title: Effect of Protein Supplementation in Hospitalized Patients With Hyponatremia Due to the Syndrome of Inappropriate Antidiuresis - a Monocentric Randomized Open-label Pragmatic Active-controlled Trial - the TREASUREx Trial
The goal of this study is to assess the impact of protein supplementation on hyponatremia caused by the syndrome of inappropriate antidiuresis during hospitalization.
Read the detailed description
Hyponatremia (plasma sodium <135 mmol/L) is the most common electrolyte disorder, affecting up to 30% of hospitalized patients. Chronic hyponatremia (>48 hours) is linked to longer hospital stays, higher costs, increased mortality, and morbidity (e.g., falls, fractures, cognitive deficits). The most common cause of euvolemic hyponatremia is syndrome of inappropriate antidiuresis (SIAD), characterized by excessive water retention due to dysregulated vasopressin activity. Treatment options include fluid restriction or increasing water excretion with AVP antagonists, SGLT2 inhibitors, or oral urea.
A recent trial showed that protein supplementation can induce osmotic diuresis and raise sodium levels similarly to oral urea, with better tolerability. Since protein supplementation is often used in hospitalized patients with malnutrition, this study aims to compare its acceptability to fluid restriction in hospitalized SIAD patients. This head-to-head superiority trial will randomize patients to receive either 80 g of dietary protein daily or fluid restriction (1000 mL/day) for up to 5 days. The hypothesis is that protein supplementation is significantly more acceptable to patients than fluid restriction, ultimately improving treatment outcomes.
- Being tested
- Moltein PURE Protein Powder, Fluid restriction
- Keywords
- dysregulated arginine vasopressin (AVP) secretion, increased renal AVP sensitivity, protein supplementation, fluid restriction
- Medical subject headings
- Hyponatremia, Inappropriate ADH Syndrome, Diabetes Insipidus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Moltein PURE Protein PowderDietary supplement
80 g protein supplementation per day (two bottles, each containing 40 g protein)
Fluid restrictionBehavioural
total daily fluid intake to a maximum of 1000 ml
| Study group | Role | What they receive |
|---|---|---|
| Protein Supplementation | Experimental | 80 g protein supplementation per day (two bottles, each containing 40 g protein) Receives: Dietary Supplement: Moltein PURE Protein Powder |
| Fluid restriction | Active comparator | total daily fluid intake to a maximum of 1000 ml Receives: Behavioral: Fluid restriction |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: On day 5 (or discharge)
Secondary outcomes (18)
Plasma sodium levels
Change in change in plasma sodium levels in mmol/l will be assessed at study inclusion to day 5 of treatment or until discharge
Measured: Daily measurements from the day of inclusion to day 5
Estimated glomerular filtration rate (eGFR)
Assessement of creatinine levels
Measured: On the day of inclusion and on day 5
Changes in blood electrolytes
Assessement of sodium levels
Measured: On the day of inclusion and on day 5
Changes in urine electrolytes
Assessement of sodium levels
Measured: On the day of inclusion and on day 5
Changes in glucose levels
Assessement of glucose levels
Measured: On the day of inclusion and on day 5
Changes kidney parameters
Assessement of urea and uric acid levels
Measured: On the day of inclusion and on day 5
Plasma sodium levels one day after treatment start
Plasma sodium levels 12-36 hours after treatment start in patients with a plasma sodium concentration <125 mmol/L at baseline.
Measured: On the day of inclusion and 12-36 hours after treatment initiation
Endocrine parameters
Blood levels of copeptin, aldosterone, renin, MR-proANP and NT-proBNP, apelin, etc. are assessed
Measured: On the day of inclusion and on day 5
General well-being
General well-being measured by numerical rating scale (NRS). Score from 0-10 while 10 indicates improved well-being
Measured: On the day of inclusion and on day 5
Symptoms of hyponatremia
Symptoms of hyponatremia (e.g. vertigo, headache, nausea, attention deficit, mental slowness, forgetfulness, gait instability) assessed by a questionnaire (yes/no; if yes: VAS, 0-10).
Measured: On the day of inclusion and on day 5
Fluid intake
Oral daily fluid intake assessed using a self-completed drinking protocol.
Measured: Daily measurements from the day of inclusion to day 5
Changes in body weight
Body weight is assessed
Measured: On the day of inclusion and on day 5
Changes in blood pressure
Systolic and diastolic blood pressure will be measured
Measured: On the day of inclusion and on day 5
Changes in heart rate
Heart rate will be assessed
Measured: On the day of inclusion and on day 5
Differences in clinical outcomes - length of hospital stays
Length of hospital stays will be assessed
Measured: Daily from the day of inclusion to day 5
Need for additional hyponatremia treatment and treatment escalation
Assessment of treatment escalation (YES/NO) including: A: administration of 3% NaCl infusion; B: administration of oral urea; C administration of SGLT2 inhibitors; D: administration of vaptans; E: administration of diuretics; F: other during the treatment period.
Measured: Daily from the day of inclusion to day 5
Treatment compliance
The participant's daily consumption of protein drinks and/or their adherence to a fluid restriction regimen is recorded.
Measured: Daily from the day of inclusion to day 5
Quality of life (EQ-5D-5L) questionnaire
Participants' health-related quality of life is assessed using the EuroQol 5 Dimensions, 5 Levels (EQ-5D-5L) questionnaire. , which includes five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension is rated on five levels, ranging from no problems to extreme problems.
Measured: On the day of inclusion and on day 5
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2025
- Study start14 Apr 2025
- Primary completionApr 2027 (estimated)
- Study completionApr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HyponatremiaStudies of the same condition, open and under way.
- More trials run by University Hospital, Basel, SwitzerlandThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Basel, Switzerland
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mirjam Christ-Crain, Prof. MD, Principal investigator, Universitätsspital Basel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06821802
- Sponsor's protocol ID
- 2024-02282; kt25ChristCrain2
- Acronym
- TREASUREx
- Status last verified
- Jul 2025
- First submitted
- 30 Jan 2025
- Last updated
- 10 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Protein Supplementation in Hospitalized Patients With Hyponatremia Due to the Syndrome of Inappropriate Antidiuresis - a Monocentric Randomized Open-label Pragmatic Active-controlled Trial - the TREASUREx Trial
- ClinicalTrials.gov ID
- NCT06821802
- Acronym / sponsor ID
- TREASUREx / 2024-02282; kt25ChristCrain2
- Keywords
- dysregulated arginine vasopressin (AVP) secretion, increased renal AVP sensitivity, protein supplementation, fluid restriction
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- Study start
- 14 Apr 2025 (actual)
- Primary completion
- Apr 2027 (estimated)
- Study completion
- Apr 2027 (estimated)
- First posted
- 12 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this study is to assess the impact of protein supplementation on hyponatremia caused by the syndrome of inappropriate antidiuresis during hospitalization.
Detailed description
Hyponatremia (plasma sodium <135 mmol/L) is the most common electrolyte disorder, affecting up to 30% of hospitalized patients. Chronic hyponatremia (>48 hours) is linked to longer hospital stays, higher costs, increased mortality, and morbidity (e.g., falls, fractures, cognitive deficits). The most common cause of euvolemic hyponatremia is syndrome of inappropriate antidiuresis (SIAD), characterized by excessive water retention due to dysregulated vasopressin activity. Treatment options include fluid restriction or increasing water excretion with AVP antagonists, SGLT2 inhibitors, or oral urea.
A recent trial showed that protein supplementation can induce osmotic diuresis and raise sodium levels similarly to oral urea, with better tolerability. Since protein supplementation is often used in hospitalized patients with malnutrition, this study aims to compare its acceptability to fluid restriction in hospitalized SIAD patients. This head-to-head superiority trial will randomize patients to receive either 80 g of dietary protein daily or fluid restriction (1000 mL/day) for up to 5 days. The hypothesis is that protein supplementation is significantly more acceptable to patients than fluid restriction, ultimately improving treatment outcomes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Protein Supplementation | Experimental | Dietary Supplement: Moltein PURE Protein Powder80 g protein supplementation per day (two bottles, each containing 40 g protein) |
| Fluid restriction | Active comparator | Behavioral: Fluid restrictiontotal daily fluid intake to a maximum of 1000 ml |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (14 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Moltein PURE Protein Powder80 g protein supplementation per day (two bottles, each containing 40 g protein) | Dietary supplement | Protein Supplementation |
| Fluid restrictiontotal daily fluid intake to a maximum of 1000 ml | Behavioural | Fluid restriction |
Primary outcome
Acceptability of Intervention Measure (AIM) questionnaire
Time frame: On day 5 (or discharge)
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).
18 secondary outcomes
Plasma sodium levels
Time frame: Daily measurements from the day of inclusion to day 5
Estimated glomerular filtration rate (eGFR)
Time frame: On the day of inclusion and on day 5
Changes in blood electrolytes
Time frame: On the day of inclusion and on day 5
Changes in urine electrolytes
Time frame: On the day of inclusion and on day 5
Changes in glucose levels
Time frame: On the day of inclusion and on day 5
Changes kidney parameters
Time frame: On the day of inclusion and on day 5
Plasma sodium levels one day after treatment start
Time frame: On the day of inclusion and 12-36 hours after treatment initiation
Endocrine parameters
Time frame: On the day of inclusion and on day 5
General well-being
Time frame: On the day of inclusion and on day 5
Symptoms of hyponatremia
Time frame: On the day of inclusion and on day 5
Fluid intake
Time frame: Daily measurements from the day of inclusion to day 5
Changes in body weight
Time frame: On the day of inclusion and on day 5
Changes in blood pressure
Time frame: On the day of inclusion and on day 5
Changes in heart rate
Time frame: On the day of inclusion and on day 5
Differences in clinical outcomes - length of hospital stays
Time frame: Daily from the day of inclusion to day 5
Need for additional hyponatremia treatment and treatment escalation
Time frame: Daily from the day of inclusion to day 5
Treatment compliance
Time frame: Daily from the day of inclusion to day 5
Quality of life (EQ-5D-5L) questionnaire
Time frame: On the day of inclusion and on day 5
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Mirjam Christ-Crain, Prof. MD principal investigator
Universitätsspital Basel
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Moltein PURE Protein Powder and Fluid restriction in people with Hyponatremia and Syndrome of Inappropriate Antidiuresis, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 10 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mirjam Christ-Crain, Prof. MD (+41 61 328 70 80, mirjam.christ-crain@usb.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acceptability of Intervention Measure (AIM) questionnaire (time frame: On day 5 (or discharge)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jul 2025.