Salt supplementation for older adults with orthostatic hypotension
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.
This study is testing if adding more salt to the diet can help older adults with low blood pressure when they stand up feel better and improve their quality of life.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 48 (estimated) |
| Ages | 65 Years and up |
| Sex | All |
| Sponsor | University of Galway Academic / other |
| Locations | 1 site (Galway) |
| Trial ID | NCT06188663 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the feasibility of conducting a randomized controlled trial on high salt intake in older adults suffering from orthostatic hypotension. It will assess recruitment, retention, and adherence while also estimating the effects of increased salt intake on quality of life and blood pressure parameters. Participants will receive encapsulated sodium chloride as a supplement to their diet. The study focuses on older adults who experience symptoms related to orthostatic hypotension.
Who should consider this trial
Good fit: Ideal candidates are adults aged 65 and older with documented orthostatic hypotension and moderate baseline salt intake.
Not a fit: Patients with severe supine hypertension or advanced heart failure may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve the quality of life and reduce fall risk in older adults with orthostatic hypotension.
How similar studies have performed: Previous studies on salt intake in similar populations have shown mixed results, indicating that this approach is still under investigation.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Exclusion Criteria: * 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 * 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)
Where this trial is running
Galway
- Clinical Research Facility Galway/Galway University Hospital — Galway, Ireland (Recruiting)
Study contacts
- Principal investigator: Martin O'Donnell — University of Galway
- Study coordinator: Catriona Reddin
- Email: catriona.reddin@universityofgalway.ie
- Phone: 086-1438101
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.