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

What this Trial Is About

Orthostatic hypotension (OH) is a common condition in older adults that can cause falls and serious injuries such as hip fractures. Current guidelines suggest increasing salt intake for patients with symptomatic OH, but the supporting evidence comes from small studies with short follow-up periods. This trial aims to assess the feasibility of conducting a larger study on the effects of high salt intake in older adults with symptomatic OH, and to gather preliminary data on quality of life, blood pressure changes, and heart-related biomarkers. The study is a Phase IIa, randomized controlled trial with two groups: one receiving salt supplementation through capsules totaling 5 grams of sodium chloride daily in two divided doses, and the other maintaining their usual salt intake without changes. The intervention will last for 12 months, and participants will be monitored throughout this period to assess adherence and effects. The trial is conducted at a single center and includes comprehensive follow-up to evaluate outcomes related to orthostatic hypotension and cardiovascular health. Participants aged 65 and older with a confirmed diagnosis of symptomatic orthostatic hypotension will take part in the trial. They will undergo assessments including questionnaires on symptoms, blood pressure measurements in different positions, 24-hour blood pressure monitoring, and blood tests for cardiac biomarkers. Researchers will track recruitment, retention, adherence, symptom changes, medication adjustments, falls, and laboratory results over six months, with a primary focus on feasibility and preliminary efficacy. The total follow-up period for recruitment is 15 months, with key measurements at 6 months.

SalT Supplementation in Older Adults With Orthostatic Intolerance Disorders