Can a simple supplement fix stubborn low sodium?
NCT ID NCT07528365
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests if oral urea can safely raise sodium levels in people with SIAD (a condition causing low sodium) when drinking less fluid isn't enough. Twenty adults with chronic SIAD will take urea for several weeks. The goal is to see if sodium levels improve and stay stable.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 20 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Sep 2024
- Expected to finish
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Dec 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Confirmed diagnosis of SIAD established prior to study inclusion, defined as: * Plasma sodium concentration \<135 mmol/L * Plasma osmolality \<300 mOsm/kg * Urine osmolality \>100 mOsm/kg * Urine sodium concentration \>30 mmol/L * Intact adrenal and thyroidal function and no use of diuretics in the last 4 weeks * Clinical euvolemia, defined as an absence of signs of hypovolemia (orthostasis, tachycardia, decreased skin turgor, dry mucous membranes) or hypervolemia (edema, ascites) Fulfillment of all diagnostic criteria at baseline (day 0) was not mandatory, as the diagnosis of SIAD had already been established prior to study inclusion based on overall clinical assessment. \- Written informed consent obtained Exclusion Criteria: * Chronic hypotonic hyponatremia secondary to another etiology * Presence of moderate to severe symptoms attributable to plasma hypotonicity * Severe hypotonic hyponatremia (serum sodium \<120 mmol/L) * Another ongoing drug treatment for hyponatremia (including vaptans and salt tablets) * Severe hepatic insufficiency * eGFR \<45 mL/min/1.73 m² * Pregnancy or breastfeeding * Known allergy or intolerance to urea * Patient refusal or inability to provide written informed consent
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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AOU Città della Salute e della Scienza
RECRUITINGTurin, Piedmont, Italy, 10126, Italy