Iron Sucrose in Patients With Iron Deficiency and 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

WITHDRAWN

Clinical Phase

PHASE2

Study Classification

INTERVENTIONAL

Study Start Date

2021-04-30

Study Completion Date

2023-05-31

Brief Summary

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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).

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Detailed Description

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Conditions

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Iron-deficiency Postural Orthostatic Tachycardia Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Iron Sucrose Group

Subjects will receive intravenous iron sucrose during a tilt table test

Group Type EXPERIMENTAL

Sucrose

Intervention Type DRUG

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

Tilt Table Test

Intervention Type DIAGNOSTIC_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.

Placebo Group

Subjects will receive intravenous placebo during a tilt table test

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

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

Tilt Table Test

Intervention Type DIAGNOSTIC_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.

Interventions

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Sucrose

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

Intervention Type DRUG

Placebo

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

Intervention Type DRUG

Tilt 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.

Intervention Type DIAGNOSTIC_TEST

Other Intervention Names

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Venofer

Eligibility Criteria

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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

Minimum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes