Restoring Iron Deficiency in POTS

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE2

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-11-24

Study Completion Date

2026-12-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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POTS - Postural Orthostatic Tachycardia Syndrome

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Intravenous Iron Infusion

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

Group Type EXPERIMENTAL

Intravenous iron

Intervention Type DRUG

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

Interventions

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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.

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No