A Randomized, Controlled, Double Blinded Clinical Trial of Intravenous Iron Sucrose in Adolescents With Non-anemic Iron Deficiency and Postural Orthostatic Tachycardia Syndrome (POTS)

Location:

Rochester, Minn.

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?

Inclusion criteria - 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 Exclusion criteria - 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

Last updated:

5/30/2014

NCT ID:

NCT01978535

IRB Number:

12-009963