Healthy AgeingVENUSNCT06930300
Vasopressin in the Elderly: Physiological Changes in Neuroendocrine Function and Urinary Secretion in Healthy Aging
A study testing Hypertonic 3% saline and Water in people with Healthy Ageing, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
Trial summary
Elderly people are at a high risk for disturbances in water homeostasis, with both hypo- and hypernatremia being more common with increasing age. Several changes in the physiology of the ageing body are responsible for this predisposition towards hypo- and hypernatremia, including diminished thirst perception… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy Ageing
- What is being tested?
- Hypertonic 3% saline and Water
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteSwitzerland
- Study dates
- 30 Apr 2025to 10 Oct 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age 18-30 years or ≥ 60 years
- Normonatremia (135-145 mmol/L)
- Plasma osmolality 280-300 mOsm/kg
- BMI ≥18 and ≤ 30 kg/m2
Who cannot join
- Regular use of medication with effects on water homeostasis (e.g. blood pressure medication, neuroleptics, desmopressin, etc.)
- Any severe disease requiring frequent medical care, except physiotherapy and/or psychotherapy
- Pacemaker or ICD
- History of thrombosis
- Active oncologic disease
- Heart failure
Show all 14Show fewer
- Liver cirrhosis
- Estimated glomerular filtration rate (eGFR) < 60 ml/kg/1.73 m2
- Uncontrolled hypertension >160 mmHg systolic or >100 mmHg diastolic
- Polydipsia (ingestion of >3L fluids per day) and polyuria (>50 ml/kg urine production within 24 hours)
- Pregnancy or breastfeeding
- Participation in a study with investigational drugs within 30 days
- Acute illness
- Inability to follow study procedures
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
University Hospital Basel
Basel, Canton of Basel-City, 4031
About this study
Elderly people are at a high risk for disturbances in water homeostasis, with both hypo- and hypernatremia being more common with increasing age. Several changes in the physiology of the ageing body are responsible for this predisposition towards hypo- and hypernatremia, including diminished thirst perception, decreasing kidney function, and altered body composition. In addition, age-related changes in AVP secretion have been suggested, but findings remain inconclusive. Possibly, this controversy is due to measurement challenges of AVP.
Copeptin, a surrogate marker of AVP-release, is more stable and a reliable assay is commercially available. While copeptin stimulation and suppression has been studied in healthy volunteers, no study assessed possible changes in copeptin dynamics occurring with ageing.
Read more
Therefore, the aim of this study is to investigate copeptin levels in hypo- and hyperosmolar states in generally healthy elderly adults compared to young controls. The investigators hypothesize that both the suppression and stimulation of copeptin is impaired and that the overall range of variation is diminished with increasing age.
This is a monocentric open-labeled randomized controlled trial conducted at the university hospital Basel. All participants will be scheduled for a copeptin stimulation test using hypertonic saline infusion and a copeptin suppression test using water ingestion. The order of the two study visits will be randomized at study inclusion.
- Conditions
- Healthy Ageing
- Being tested
- Hypertonic 3% saline, Water
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hypertonic 3% salineOther
Participants receive 10 ml/kg body weight of 3% saline infused over 1 hour. The aim is to stimulate copeptin release.
WaterOther
Participants ingest 20 ml/kg water over 1h. The aim is to suppress copeptin release.
| Study group | Role | What they receive |
|---|---|---|
| Stimulation first, Suppression second | Experimental | Not described Receives: Other: Hypertonic 3% saline; Other: Water |
| Suppression first, Stimulation second | Experimental | Not described Receives: Other: Hypertonic 3% saline; Other: Water |
What is being measured
The primary outcome is the main question the study is designed to answer.
Range of Variation in Copeptin
The primary outcome is the range of variation in copeptin, i.e. difference of suppressed copeptin to the stimulated copeptin, in healthy elderly participants compared to young controls.
Measured: Baseline, 15 minutes, 30 minutes, 45 minutes, 60 minutes, and 120 minutes both after saline administration and after water ingestion
Secondary outcomes (22)
Changes in Copeptin upon stimulation and suppression
Measured: Baseline, 15 minutes, 30 minutes, 45 minutes, 60 minutes, and 120 minutes both after saline administration and after water ingestion
Differences in total body water (L) measured by body impedance analysis
Measured: at Baseline
Changes in cortisol (mmol/L)
Measured: Baseline, 60 minutes, and 120 minutes both after saline administration and after water ingestion
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
Measured: Baseline, 15 minutes, 30 minutes, 45 minutes, 60 minutes, and 120 minutes both after saline administration and after water ingestion
Changes in blood pressure (mmHg)
Measured: Baseline, 15 minutes, 30 minutes, 45 minutes, 60 minutes, and 120 minutes both after saline administration and after water ingestion
Changes in heart rate
Measured: Baseline, 15 minutes, 30 minutes, 45 minutes, 60 minutes, and 120 minutes both after saline administration and after water ingestion
Changes in plasma sodium (mmol/L)
Measured: Baseline, 15 minutes, 30 minutes, 45 minutes, 60 minutes, and 120 minutes both after saline administration and after water ingestion
Changes in plasma potassium (mmol/L)
Measured: Baseline, 15 minutes, 30 minutes, 45 minutes, 60 minutes, and 120 minutes both after saline administration and after water ingestion
Changes in plasma chloride (mmol/L)
Measured: Baseline, 15 minutes, 30 minutes, 45 minutes, 60 minutes, and 120 minutes both after saline administration and after water ingestion
Changes in plasma osmolality (mOsm/kg)
Measured: Baseline, 15 minutes, 30 minutes, 45 minutes, 60 minutes, and 120 minutes both after saline administration and after water ingestion
Changes in estimated glomerular filtration rate (ml/kg/1.73m2)
Measured: Baseline, 60 minutes, and 120 minutes both after saline administration and after water ingestion
Changes in plasma glucose (mmol/L)
Measured: Baseline, 15 minutes, 30 minutes, 45 minutes, 60 minutes, and 120 minutes both after saline administration and after water ingestion
Changes in plasma urea (mmol/L)
Measured: Baseline, 15 minutes, 30 minutes, 45 minutes, 60 minutes, and 120 minutes both after saline administration and after water ingestion
Changes in plasma uric acid (umol/L)
Measured: Baseline, 15 minutes, 30 minutes, 45 minutes, 60 minutes, and 120 minutes both after saline administration and after water ingestion
Changes in urine osmolality (mOsm/kg)
Measured: Baseline, 60 minutes, and 120 minutes both after saline administration and after water ingestion
Changes in urine sodium (mmol/L)
Measured: Baseline, 60 minutes, and 120 minutes both after saline administration and after water ingestion
Changes in urine potassium (mmol/L)
Measured: Baseline, 60 minutes, and 120 minutes both after saline administration and after water ingestion
Changes in urine chloride (mmol/L)
Measured: Baseline, 60 minutes, and 120 minutes both after saline administration and after water ingestion
Changes in urine urea (mmol/L)
Measured: Baseline, 60 minutes, and 120 minutes both after saline administration and after water ingestion
Changes in urine uric acid (umol/L)
Measured: Baseline, 60 minutes, and 120 minutes both after saline administration and after water ingestion
Changes in urine glucose (mmol/L)
Measured: Baseline, 60 minutes, and 120 minutes both after saline administration and after water ingestion
Changes in urine creatinine (umol/L)
Measured: Baseline, 60 minutes, and 120 minutes both after saline administration and after water ingestion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2025
- Study start30 Apr 2025
- Primary completion10 Oct 2025
- Study completion10 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy AgeingStudies of the same condition, open and under way.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Basel, Switzerland
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06930300
- Sponsor's protocol ID
- 2025-00474
- Other IDs
- 2025
- Acronym
- VENUS
- Status last verified
- Jan 2026
- First submitted
- 25 Mar 2025
- Last updated
- 13 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vasopressin in the Elderly: Physiological Changes in Neuroendocrine Function and Urinary Secretion in Healthy Aging
- ClinicalTrials.gov ID
- NCT06930300
- Acronym / sponsor ID
- VENUS / 2025-00474
- Conditions
- Healthy Ageing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- Study start
- 30 Apr 2025 (actual)
- Primary completion
- 10 Oct 2025 (actual)
- Study completion
- 10 Oct 2025 (actual)
- First posted
- 16 Apr 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.
Elderly people are at a high risk for disturbances in water homeostasis, with both hypo- and hypernatremia being more common with increasing age. Several changes in the physiology of the ageing body are responsible for this predisposition towards hypo- and hypernatremia, including diminished thirst perception, decreasing kidney function, and altered body composition. In addition, age-related changes in AVP secretion have been suggested, but findings remain inconclusive. Possibly, this controversy is due to measurement challenges of AVP.
Copeptin, a surrogate marker of AVP-release, is more stable and a reliable assay is commercially available. While copeptin stimulation and suppression has been studied in healthy volunteers, no study assessed possible changes in copeptin dynamics occurring with ageing.
Therefore, the aim of this study is to investigate copeptin levels in hypo- and hyperosmolar states in generally healthy elderly adults compared to young controls. The investigators hypothesize that both the suppression and stimulation of copeptin is impaired and that the overall range of variation is diminished with increasing age.
This is a monocentric open-labeled randomized controlled trial conducted at the university hospital Basel. All participants will be scheduled for a copeptin stimulation test using hypertonic saline infusion and a copeptin suppression test using water ingestion. The order of the two study visits will be randomized at study inclusion.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Stimulation first, Suppression second | Experimental | Other: Hypertonic 3% saline, Other: Water |
| Suppression first, Stimulation second | Experimental | Other: Hypertonic 3% saline, Other: Water |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age 18-30 years or ≥ 60 years
- Normonatremia (135-145 mmol/L)
- Plasma osmolality 280-300 mOsm/kg
- BMI ≥18 and ≤ 30 kg/m2
Key exclusion criteria (14 listed)
- Regular use of medication with effects on water homeostasis (e.g. blood pressure medication, neuroleptics, desmopressin, etc.)
- Any severe disease requiring frequent medical care, except physiotherapy and/or psychotherapy
- Pacemaker or ICD
- History of thrombosis
- Active oncologic disease
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 |
|---|---|---|
| Hypertonic 3% salineParticipants receive 10 ml/kg body weight of 3% saline infused over 1 hour. The aim is to stimulate copeptin release. | Other | Stimulation first, Suppression second, Suppression first, Stimulation second |
| WaterParticipants ingest 20 ml/kg water over 1h. The aim is to suppress copeptin release. | Other | Stimulation first, Suppression second, Suppression first, Stimulation second |
Primary outcome
Range of Variation in Copeptin
Time frame: Baseline, 15 minutes, 30 minutes, 45 minutes, 60 minutes, and 120 minutes both after saline administration and after water ingestion
The primary outcome is the range of variation in copeptin, i.e. difference of suppressed copeptin to the stimulated copeptin, in healthy elderly participants compared to young controls.
22 secondary outcomes
Changes in Copeptin upon stimulation and suppression
Time frame: Baseline, 15 minutes, 30 minutes, 45 minutes, 60 minutes, and 120 minutes both after saline administration and after water ingestion
Differences in total body water (L) measured by body impedance analysis
Time frame: at Baseline
Changes in cortisol (mmol/L)
Time frame: Baseline, 60 minutes, and 120 minutes both after saline administration and after water ingestion
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
Time frame: Baseline, 15 minutes, 30 minutes, 45 minutes, 60 minutes, and 120 minutes both after saline administration and after water ingestion
Changes in blood pressure (mmHg)
Time frame: Baseline, 15 minutes, 30 minutes, 45 minutes, 60 minutes, and 120 minutes both after saline administration and after water ingestion
Changes in heart rate
Time frame: Baseline, 15 minutes, 30 minutes, 45 minutes, 60 minutes, and 120 minutes both after saline administration and after water ingestion
Changes in plasma sodium (mmol/L)
Time frame: Baseline, 15 minutes, 30 minutes, 45 minutes, 60 minutes, and 120 minutes both after saline administration and after water ingestion
Changes in plasma potassium (mmol/L)
Time frame: Baseline, 15 minutes, 30 minutes, 45 minutes, 60 minutes, and 120 minutes both after saline administration and after water ingestion
Changes in plasma chloride (mmol/L)
Time frame: Baseline, 15 minutes, 30 minutes, 45 minutes, 60 minutes, and 120 minutes both after saline administration and after water ingestion
Changes in plasma osmolality (mOsm/kg)
Time frame: Baseline, 15 minutes, 30 minutes, 45 minutes, 60 minutes, and 120 minutes both after saline administration and after water ingestion
Changes in estimated glomerular filtration rate (ml/kg/1.73m2)
Time frame: Baseline, 60 minutes, and 120 minutes both after saline administration and after water ingestion
Changes in plasma glucose (mmol/L)
Time frame: Baseline, 15 minutes, 30 minutes, 45 minutes, 60 minutes, and 120 minutes both after saline administration and after water ingestion
Changes in plasma urea (mmol/L)
Time frame: Baseline, 15 minutes, 30 minutes, 45 minutes, 60 minutes, and 120 minutes both after saline administration and after water ingestion
Changes in plasma uric acid (umol/L)
Time frame: Baseline, 15 minutes, 30 minutes, 45 minutes, 60 minutes, and 120 minutes both after saline administration and after water ingestion
Changes in urine osmolality (mOsm/kg)
Time frame: Baseline, 60 minutes, and 120 minutes both after saline administration and after water ingestion
Changes in urine sodium (mmol/L)
Time frame: Baseline, 60 minutes, and 120 minutes both after saline administration and after water ingestion
Changes in urine potassium (mmol/L)
Time frame: Baseline, 60 minutes, and 120 minutes both after saline administration and after water ingestion
Changes in urine chloride (mmol/L)
Time frame: Baseline, 60 minutes, and 120 minutes both after saline administration and after water ingestion
Changes in urine urea (mmol/L)
Time frame: Baseline, 60 minutes, and 120 minutes both after saline administration and after water ingestion
Changes in urine uric acid (umol/L)
Time frame: Baseline, 60 minutes, and 120 minutes both after saline administration and after water ingestion
Changes in urine glucose (mmol/L)
Time frame: Baseline, 60 minutes, and 120 minutes both after saline administration and after water ingestion
Changes in urine creatinine (umol/L)
Time frame: Baseline, 60 minutes, and 120 minutes both after saline administration and after water ingestion
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2026.
- Individual participant dataSharing planned: Undecided
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hypertonic 3% saline and Water in people with Healthy Ageing, 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 4 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: finished, as of the sponsor's last update on 13 Jan 2026. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Range of Variation in Copeptin (time frame: Baseline, 15 minutes, 30 minutes, 45 minutes, 60 minutes, and 120 minutes both after saline administration and after water ingestion). 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 13 Jan 2026.