Iron Sucrose in Patients With Iron Deficiency and POTS

A Randomized, Controlled, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy of Intravenous Iron Sucrose in Patients With Non-anemic Iron Deficiency and Postural Orthostatic Tachycardia Syndrome (POTS)

Status

Withdrawn

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04855266

Enrollment

Registered

2021-04-22

Start date

2021-04-30

Completion date

2023-05-31

Last updated

2023-06-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Iron-deficiency, Postural Orthostatic Tachycardia Syndrome

Brief summary

This study aims to investigate whether the treatment of non-anemic iron deficiency with intravenous iron sucrose will result in decreased symptom reporting and improved cardiovascular indices in patients with Postural Orthostatic Tachycardia syndrome (POTS).

Interventions

DRUGSucrose

5 mg/kg of intravenous iron sucrose (maximum dose of 200 mg). Iron sucrose will be diluted

DRUGPlacebo

Normal saline (NaCl 0.9%) 5 mL/kg (maximum volume 210 mL)

DIAGNOSTIC_TESTTilt Table Test

A table that adjusts the body position from horizontal to vertical to simulate standing up. Heart rate and blood pressure are monitored throughout the test.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

12 Years to No maximum

Healthy volunteers

Yes

Inclusion criteria

* Patients (age 12 to years and older) with chronic (\>3 months) symptoms of orthostatic intolerance, including but not limited to lightheadedness, syncope, headache, fatigue, weakness, sweating, nausea and heart palpitations. * Symptomatic orthostatic heart rate increment ≥30 bpm if \>19 years old or ≥40 bpm if \<19 years old during a 10 minute 70 degree head up tilt study * Presence of non-anemic iron deficiency, defined as serum ferritin levels \<20 ug/L with hemoglobin no less than 1 gm/dL below the normal reference range as defined for age and gender * Consent obtained from responsible guardian AND from subjects, 12-17 years of age * Consent obtained for subjects 18 years of age and older

Exclusion criteria

* Orthostatic hypotension (decrease of systolic BP\>30 mmHg and/or diastolic BP\>15mmHg within 3 minutes of 70 degree head up tilt study) * Pregnant or lactating females * The presence of failure of other organ systems or systemic illness that can affect autonomic function * Concomitant therapy with anticholinergic, alpha-adrenergic antagonists, beta-adrenergic antagonists or other medications which could interfere with autonomic testing. Patients may participate if the potentially interfering medication is held for five half-lives prior to the study * Laboratory evidence of anemia or iron overload * Personal history of hematochromatosis or first degree relative with hematochromatosis * Known sensitivity to Venofer® (iron sucrose injection, USP) or other intravenous iron preparation

Design outcomes

Primary

Measure	Time frame	Description
Change in autonomic dysfunction symptoms	Baseline, 7 days, 6 months	Measured using the self-reported Composite Autonomic Symptom Score (COMPASS) questionnaire that asks 31 questions regarding symptoms of autonomic dysfunction
Change in postural heart rate increase	Baseline, 7 days	Heart rate change during tilt table test measured in beats per minute

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026