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.

Status: Recruiting
Location: See location...
Intervention Type: Dietary supplement
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 65
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Ireland
Clinical Research Facility Galway/Galway University Hospital
RECRUITING
Galway
Contact Information
Primary
Catriona Reddin
catriona.reddin@universityofgalway.ie
086-1438101
Time Frame
Start Date: 2024-07-09
Estimated Completion Date: 2026-09
Participants
Target number of participants: 48
Treatments
Active_comparator: Salt supplementation
Salt supplementation in the form of 1.25g sodium chloride capsules at a dose of 5g/day in two divided doses
No_intervention: Usual salt intake (no change in intake)
Usual salt intake (no change in intake)
Sponsors
Leads: University of Galway
Collaborators: Health Research Board, Ireland

This content was sourced from clinicaltrials.gov