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Orthostatic HypotensionPhase 2STOODNCT06188663

SalT Supplementation in Older Adults With Orthostatic Intolerance Disorders

A Phase 2 study testing Salt supplementation (encapsulated sodium chloride) in people with Orthostatic Hypotension, run by University of Galway at 1 site in Ireland.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

Background Orthostatic hypotension (OH) is a common cause of falls, and key source of morbidity and mortality due to injury (e.g. hip fracture). Current guidelines recommend increasing salt intake in patients with symptomatic orthostatic hypotension. Read more about this study

Who is it for?
Ages 65 years and older
Conditions the study is for
Orthostatic Hypotension
What is being tested?
Salt supplementation (encapsulated sodium chloride)
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
42 participants
Where
1 siteIreland
Study dates
9 Jul 2024to Sep 2026
Phase
Phase 2
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 65 years and older
  • All sexes
  • No healthy volunteers
  • Older adult

Who may be able to join

  • Adults ≥ 65 years of age
  • Documented history of orthostatic hypotension, defined by decrease in systolic blood pressure (SBP) of ≥20 mmHg or a decrease in diastolic blood pressure (DBP) of ≥10 mmHg within three minutes of standing when compared with blood pressure from the supine position, or at head-up tilt testing.
  • A documented history of symptoms consistent with orthostatic hypotension including one of the following: light-headedness, dizziness, feeling faint, feeling like they may black out
  • Baseline salt intake expected to be in the moderate range (5-10g/day) based on screening questions
  • Willingness to supplement sodium intake
  • Ability to provide written informed consent

Who cannot join

  • Severe supine hypertension (Systolic blood pressure≥180mmHg or diastolic blood pressure >110mmHg) measured as average of three office readings
  • A diagnosis of Heart Failure (New York Heart Association (NYHA) Class III or IV symptoms or known left ventricular ejection fraction 30%, if more than one echo eligibility is defined by most recent echo)
  • CKD (eGFR <30ml/min/1.73m2) based on eGFR measured within the last 6 months
  • Participants taking loop diuretics
  • Serum sodium <125mmol at last measurement
  • Acute intercurrent illness
Show all 9Show fewer
  • Prescribed high-salt diet (for clinical indication other than for OH) or low-salt diet for evidence based clinical indication
  • Participant unlikely to comply with study procedures or follow-up visits due to severe comorbid illness or other factor (e.g. inability to travel for follow-up visits) in opinion of research team
  • Inability to provide informed consent in the opinion of the investigator (for example due to severe cognitive impairment)

Trial locations and contacts

1 site in 1 country.

Ireland1 site

  • Clinical Research Facility Galway/Galway University Hospital

    Galway

Other trials in Ireland

About this study

Official title: SalT Supplementation in Older Adults With Orthostatic Intolerance Disorders (STOOD): a Phase IIa Randomised Controlled Trial of Sodium Supplementation in Those Consuming Moderate Salt Intake.

Background

Orthostatic hypotension (OH) is a common cause of falls, and key source of morbidity and mortality due to injury (e.g. hip fracture). Current guidelines recommend increasing salt intake in patients with symptomatic orthostatic hypotension. However, the evidence underpinning this recommendation is poor, based primarily on small trials with very short-term follow-up (< 6 weeks).

Read more

Clinical Equipoise (Overall)

High salt intake might improve quality of life and reduce the risk of falls, but might also increase the risk of cardiovascular disease, in patients with OH.

Specific Objective of Current Application (Aim)

To determine feasibility (recruitment, retention and adherence) of conducting a randomized controlled trial evaluating high salt intake in older adults with symptomatic orthostatic hypotension.

To determine preliminary estimates of the effect of high salt intake on disease-specific quality of life, orthostatic blood pressure (BP) parameters, and cardiac blood biomarkers.

Design: Phase IIa, parallel, double-blind, randomised controlled, single centre clinical trial of 12 month follow-up duration.

Population: Older adults (≥65 years of age) with an objective diagnosis of symptomatic orthostatic hypotension

Intervention: The intervention will be 5g/day of salt supplementation in the form of encapsulated sodium chloride.

Outcome measures: Primary outcome (Feasibility) recruitment and retention rates, adherence with intervention and study protocol, completeness of follow-up. Secondary Outcome (Efficacy): i) clinical: change in Orthostatic Hypotension Questionnaire score, modification/addition of OH pharmacotherapy, and falls events, ii) physiological measures of orthostasis: change in difference between supine and nadir systolic BP, standing BP at 1 minute, 24 hour mean BP measured by 24 hour ambulatory BP monitor, iii) cardiovascular biomarkers.

Clinical Importance:

A recommendation for long-term increases in salt intake may have adverse cardiovascular consequences, which necessitates the identification of the optimal range of salt intake associated with greatest reduction in falls risk and lowest cardiovascular risk. Our study will provide preliminary evidence of treatment effect and assess feasibility, to inform a definitive trial.

Being tested
Salt supplementation (encapsulated sodium chloride)
Keywords
Orthostatic Hypotension, Sodium, Diet
Medical subject headings
Hypotension, Orthostatic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Salt supplementation (encapsulated sodium chloride)Dietary supplement

    A high salt intake range will be achieved through unchanged dietary intake and supplementary salt in the form of 1.25g sodium chloride capsules at a dose of 5g/day in two divided doses

Study groups in NCT06188663
Study groupRoleWhat they receive
Salt supplementationActive comparatorSalt supplementation in the form of 1.25g sodium chloride capsules at a dose of 5g/day in two divided doses
Receives: Dietary Supplement: Salt supplementation (encapsulated sodium chloride)
Usual salt intake (no change in intake)No interventionUsual salt intake (no change in intake)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Recruitment to target (primary feasibility outcome)

    Recruitment of 48 participants

    Measured: 15 months

  2. Change in orthostatic hypotension questionnaire score (primary efficacy outcome)

    Change in symptoms and quality of life measured using disease specific questionnaire; Orthostatic Hypotension Questionnaire (OHQ) from baseline to final follow-up. All questionnaire items are scored 0 through 10 (higher scores = worse).

    Measured: 6 months

Secondary outcomes (10)

  1. Change in individual components of OHQ from baseline to final follow-up

    Change in individual components of OHQ from baseline to final follow-up. All questionnaire items are scored 0 through 10 (higher scores = worse).

    Measured: 6 months

  2. Rates of modification/addition of OH pharmacotherapy

    Rates of modification/addition of OH pharmacotherapy

    Measured: 6 months

  3. Rates of modification/addition of anti-hypertensive therapy

    Rates of modification/addition of anti-hypertensive therapy

    Measured: 6 months

  4. Falls events

    Number of falls events

    Measured: 6 months

  5. Change in difference between supine and nadir blood pressure from baseline to final in-person follow-up

    Change in difference between supine and nadir blood pressure from baseline to final in-person follow-up

    Measured: 6 months

  6. Change in standing BP at one minute and three minutes

    Change in standing BP at one minute and three minutes measured at active stand

    Measured: 6 months

  7. Change in mean BP measured by 24 hour ambulatory BP monitor

    Change in mean BP measured by 24 hour ambulatory BP monitor

    Measured: 6 months

  8. Change in cardiovascular biomarkers; proBNP and troponin

    Change in cardiovascular biomarkers; proBNP and troponin

    Measured: 6 months

  9. Change in formula derived 24 hour urinary sodium from baseline to final in-person follow-up visit.

    Change in formula derived 24 hour urinary sodium

    Measured: 6 months

  10. Change in renin-aldosterone ratio from baseline to final in-person follow-up visit.

    Change in renin-aldosterone ratio from baseline to final in-person follow-up visit.

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Jan 2024
  2. Study start9 Jul 2024
  3. Primary completionJul 2026 (estimated)
  4. Study completionSep 2026 (estimated)

Resources

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 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
42 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06188663
Sponsor's protocol ID
C.A.3086
Acronym
STOOD
Status last verified
Jun 2026
First submitted
17 Dec 2023
Last updated
22 Jun 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Reddin C, Smyth A, McDermott S, McDermott C, Mannion E, Davies N, Iglesias AA, Sheldon R, Canavan M, Kenny RA, O'Donnell M. SalT supplementation in Older adults with Orthostatic intolerance Disorders (STOOD) trial: a study protocol for a feasibility randomised controlled trial. Pilot Feasibility Stud. 2026 Jul 16. doi: 10.1186/s40814-026-01885-9. Online ahead of print.

    PubMed 42464391

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Salt supplementation (encapsulated sodium chloride) in people with Orthostatic Hypotension, run by University of Galway at 1 site in Ireland.

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 9 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: under way, not looking for participants, as of the sponsor's last update on 22 Jun 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 Ireland. 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.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

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?

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?

Recruitment to target (primary feasibility outcome) (time frame: 15 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06188663, which also lists 1 linked publication.

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 22 Jun 2026.

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