SalT Supplementation in Older Adults With Orthostatic Intolerance Disorders

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). 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.

NCT Number	NCT06188663
Lead Sponsor	University of Galway Collaborators: Health Research Board, Ireland
Conditions	Orthostatic Hypotension
Enrollment	42 participants
Start Date	2024-07-09
Primary Completion	2026-07 (estimated)
Study Completion	2026-09 (estimated)
Updated on ClinicalTrials.gov	2026-06-22