Restoring Iron Deficiency in POTS
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexFemale
Age18-45
SponsorVanderbilt University Medical Center
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
Unable or unwilling to provide consent.
Pregnancy.
Being chair- or bed-ridden.
Unable to hold POTS medications during study procedures (i.e., autonomic testing).
Trial design
Design model
Single group
Treatments tested in this trial
Intravenous iron
DrugThe Intravenous iron infusion will be administered according to standard clinical care. The provider will choose the dosage and formulation of IV iron.
Treatment groups
12 Participants
are divided into 1 treatment groupGroup A: Intravenous Iron InfusionExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Orthostatic tachycardia
Orthostatic tachycardia, defined as the difference between upright and supine heart rates, will be assessed during a 10-minute head-up tilt test.
Time frame
Orthostatic tachycardia will be assessed before iron infusion (Visit 1) and after 2 months of treatment (Visit 2)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Vanderbilt University Medical Center
Lead sponsor
Dysautonomia International
Collaborator
Source ClinicalTrials.gov