A Randomized, Controlled, Double Blinded Clinical Trial of Intravenous Iron Sucrose in Adolescents With Non-anemic Iron Deficiency and Postural Orthostatic Tachycardia Syndrome (POTS)
Trial status: Open for Enrollment
Why is this study being done?
This study is designed to investigate whether the treatment of non-anemic iron deficiency with intervenous iron sucrose will result in decreased symptom reporting and improved cardiovascular indices in adolescents (age 12-18) with Postural Orthostatic Tachycardia Syndrome (POTS).
Who is eligible to participate?
- aged 12-18 years
- chronic (>3 months)symptoms of orthostatic intolerance (including but not limited to lightheadedness, syncope, headache, fatigue, weakness, sweating, nausea and palpitations)
- symptomatic orthostatic heart rate increase of greater than or equal to 40 beats per minute during a 10 minute 70 degree head up tilt study
- presence of non-anemic iron deficiency, defined as serum ferritin level less than or equal to 12 ug/L with normal hemoglobin
- orthostatic hypotension within 3 minutes of 70 degree head up tilt
- pregnant or lactating females
- presence of other organ failure or systemic illness that can affect autonomic function
- concurrent medication therapy with anticholinergic, alpha-adrenergic antagonists, beta-adrenergic antagonists unless medication is held for five half-lives prior to study
- laboratory evidence of anemia or iron overload
- personal history of hematochromatosis or first degree relative with hematochromatosis
- known sensitivity to Venofer (TM) or other intravenous iron preparations