SalT Supplementation in Older Adults With Orthostatic Intolerance Disorders

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. 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.

Conditions

• Orthostatic Hypotension

Interventions

DIETARY_SUPPLEMENT

Salt supplementation (encapsulated sodium chloride)

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

Sponsors & Collaborators

• Health Research Board, Ireland

  collaborator OTHER

• University of Galway

  lead OTHER

Principal Investigators

• Martin O'Donnell · University of Galway

• Catriona Reddin · University of Galway

• Andrew Smyth · University of Galway

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

65 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-07-09

Primary Completion

2026-03-31

Completion

2026-09-30

Countries

• Ireland

Study Locations