Iron Sucrose in Adolescents With Iron Deficiency and Postural Orthostatic Tachycardia Syndrome (POTS)
Stopped early · Phase 1/Phase 2
Conditions studied: Postural Orthostatic Tachycardia Syndrome
In brief
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).
Key facts
- Study ID
- NCT01978535
- Run by
- Mayo Clinic
- People needed
- 3
- Starts
- 2014-12-17
- Expected to finish
- 2017-09-08
- Last updated by the study team
- 2017-11-17
Who can join
Age: 12 and older, up to 21. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Mayo Clinic in Rochester — Rochester, Minnesota, United States
Full record on ClinicalTrials.gov
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