- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01978535
Iron Sucrose in Adolescents With Iron Deficiency and Postural Orthostatic Tachycardia Syndrome (POTS)
A Randomized, Controlled, Double Blinded Clinical Trial of Intravenous Iron Sucrose in Adolescents With Non-anemic Iron Deficiency and Postural Orthostatic Tachycardia Syndrome (POTS)
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Postural orthostatic tachycardia syndrome (POTS) is characterized by an exaggerated heart rate response to the standing position in a patient with symptoms of orthostatic intolerance. It is likely a heterogeneous disorder representing a common manifestation of a number of possible underlying derangements such as impaired sympathetically mediated vasoconstriction, excessive sympathetic drive, volume dysregulation and deconditioning. While the actual prevalence of POTS is unknown, it has been estimated to affect at least 500,000 individuals in the United States. It predominately affects young individuals, and particularly women.
The prevalence of iron deficiency in adolescents with POTS has been reported to be greater than that expected in the general adolescent population. The use of intravenous iron sucrose has been shown to be a safe and effective therapy for correcting iron deficiency in children and adolescents. Anecdotal experience at our clinic has demonstrated an immediate reduction in self-reported orthostatic symptoms in several patients diagnosed with POTS following the administration of intravenous iron sucrose for iron deficiency.
This study is a randomized, double blind, placebo-controlled study to assess the efficacy of a single iron sucrose infusion in adolescents with non-anemic iron deficiency and POTS. Subjects will be screened at outpatient clinic visit appointments. Interested qualified subjects will be consented and offered participation in this trial. Once consent and assent (for patients less than 18 years of age) has been obtained, subjects will be randomized to either treatment or placebo group. Subjects will participate in two on site study visits. During the first visit subjects will complete baseline laboratory studies, tilt table test and study questionnaires. Subjects will then receive the intervention study drug or placebo. The second study visit will occur 7 days + 2 days from the first study visit. During the second study visit subjects will repeat laboratory studies, tilt table test and study questionnaires. Follow up questionnaires will be sent to all subjects six months following the initial study visit.
Study Type
Enrollment (Actual)
Phase
- Phase 2
- Phase 1
Contacts and Locations
Study Locations
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Minnesota
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Rochester, Minnesota, United States, 55905
- Mayo Clinic in Rochester
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Iron infusion
Iron Sucrose (Venofer (R))
|
5 mg/kg of intravenous iron sucrose supplied as Venofer (TM) with a maximum dose of 200mg.
Iron sucrose will be diluted to 1 mg of elemental iron in 1 mL of NaCl 0.9% with a maximum volume of 210 mL.
Other Names:
|
Placebo Comparator: Normal saline infusion
Equal volume to intervention of normal saline
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Normal saline (NaCl 0.9%) 5 mL/kg up to a maximum volume 210 mL
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Cardiovascular Indices-interval Change in Heart Rate During 10-minute Head up Tilt Table Test
Time Frame: 7 (+/- 2) days following intervention
|
This study will assess whether a single infusion of iron sucrose will improve cardiovascular indices, specifically a reduction in the interval of measured heart rate change, during a ten minute head up tilt, in adolescent subjects with POTS and non-anemic iron deficiency
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7 (+/- 2) days following intervention
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Amie Jones, MD, Mayo Clinic
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Pathologic Processes
- Heart Diseases
- Cardiovascular Diseases
- Nervous System Diseases
- Disease
- Arrhythmias, Cardiac
- Cardiac Conduction System Disease
- Autonomic Nervous System Diseases
- Primary Dysautonomias
- Orthostatic Intolerance
- Syndrome
- Tachycardia
- Postural Orthostatic Tachycardia Syndrome
- Physiological Effects of Drugs
- Trace Elements
- Micronutrients
- Hematinics
- Iron
- Ferric Oxide, Saccharated
Other Study ID Numbers
- 12-009963
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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