Recruiting
Phase 2

Iron

Sponsor:

Vanderbilt University Medical Center

Code:

NCT07197905

Conditions

POTS - Postural Orthostatic Tachycardia Syndrome

Eligibility Criteria

Sex: Female

Age: 18 - 45

Healthy Volunteers: Not accepted

Interventions

Intravenous iron

Study Details

Brief summary:

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.

Conditions

POTS - Postural Orthostatic Tachycardia Syndrome

Study ID

NCT07197905

Start date

Nov 24, 2025

Status verified date

Dec, 2025

Completion date

Dec, 2026

Anticipated

Primary completion date

Oct, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18 - 45

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

12 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Intravenous Iron Infusion

The Intravenous iron infusion will be administered according to standard clinical care.

Interventions

Intravenous iron

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

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Megan Orillion, BSN, RN

615-875-9405autonomics@vumc.org

Luis E Okamoto, MD

615-936-6119autonomics@vumc.org

Locations

Autonomic Dysfunction Center/ Vanderbilt University Medical Center

Recruiting

Nashville, Tennessee, United States, 37232

More Information

Sponsor

Vanderbilt University Medical Center

Last update posted

Dec 11, 2025

Last verified

Dec, 2025

Keywords

  • Postural Tachycardia Syndrome
  • Iron Deficiency

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Vanderbilt University Medical Center on 2025-12-11.