Skip to main content
OpenTrials
Recruiting

NCT Number: NCT07197905

Restoring Iron Deficiency in POTS

People with postural orthostatic tachycardia syndrome (POTS) often have low red blood cell volumes and low ferritin in their blood (a marker of iron storage in the body). The purpose of this pilot study is to investigate whether giving iron to people with POTS who have low ferritin levels will increase the red blood cell volume and improve POTS symptoms.

Recruiting

Interested in participating?

Request Info

Key information

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

Autonomic Dysfunction Center/ Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

Location status: Recruiting

About this study

This pilot study involves undergoing a physical exam and medical history, answering some questionnaires, and visiting the Vanderbilt Autonomic Dysfunction Center before and 2 months after the iron treatment for bloodwork, blood volume measurements, autonomic function tests, and wearing an activity monitor.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age 18-45 years old.
  • Diagnosis of POTS, defined by a sustained heart rate increase of at least 30 bpm within 10 min of standing or head-up tilt (or absolute upright heart rate >120 bpm), in the absence of orthostatic hypotension, and with at least 3 months of symptoms of orthostatic intolerance.
  • Absence of other diseases or medications that can explain orthostatic tachycardia or symptoms.
  • Serum ferritin <50 ng/ml.
  • Patients on fludrocortisone will be allowed to participate as long as they have been on the same dose for at least one month before enrollment and continue on the same dose throughout the study.

Exclusion criteria

  • Unable or unwilling to provide consent.
  • Pregnancy.
  • Being chair- or bed-ridden.
  • Unable to hold POTS medications during study procedures (i.e., autonomic testing).
  • History of active bleeding (other than menstruation).
  • History of hypersensitivity to any iron preparation of recent (within 6 months) treatment with any IV iron preparation.

Treatment and study plan

Intravenous iron

Drug

The Intravenous iron infusion will be administered according to standard clinical care. The provider will choose the dosage and formulation of IV iron.

Primary outcomes

  1. Orthostatic tachycardia

    Time frame: Orthostatic tachycardia will be assessed before iron infusion (Visit 1) and after 2 months of treatment (Visit 2)

    Orthostatic tachycardia, defined as the difference between upright and supine heart rates, will be assessed during a 10-minute head-up tilt test.

Study contacts

Contact information is provided by the study sponsor or research team.

Luis E Okamoto, MD

CONTACT

[email protected]

615-936-6119

Megan Orillion, BSN, RN

CONTACT

[email protected]

615-875-9405

Sponsors and collaborators

Lead sponsor

Vanderbilt University Medical Center

Other

Collaborators

  • Dysautonomia International

Registry information

Official study title

Restoring Iron Deficiency to Expand Blood Volume and Improve POTS

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Sep 30, 2025
Registry last updated
Dec 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.