Iron Sucrose in Adolescents With Iron Deficiency and Postural Orthostatic Tachycardia Syndrome (POTS)

• Status: Terminated
• Trial end date: 2017-09-08
• Target enrollment: 0
• Participant gender: All

Summary

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 12-21) with Postural Orthostatic Tachycardia Syndrome (POTS).

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Mayo Clinic
• Treatments: Ferric Compounds; Ferric Oxide, Saccharated; Iron

Criteria

Inclusion criteria

• aged 12-21 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 20 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