Iron Sucrose in Adolescents With Iron Deficiency and Postural Orthostatic Tachycardia Syndrome (POTS)
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|ClinicalTrials.gov Identifier: NCT01978535|
Recruitment Status : Terminated (Difficulty in recruiting subjects.)
First Posted : November 7, 2013
Results First Posted : November 17, 2017
Last Update Posted : November 17, 2017
|Condition or disease||Intervention/treatment||Phase|
|Postural Orthostatic Tachycardia Syndrome||Drug: Iron infusion Drug: Normal saline infusion||Phase 1 Phase 2|
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 :||Interventional (Clinical Trial)|
|Actual Enrollment :||3 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||A Randomized, Controlled, Double Blinded Clinical Trial of Intravenous Iron Sucrose in Adolescents With Non-anemic Iron Deficiency and Postural Orthostatic Tachycardia Syndrome (POTS)|
|Actual Study Start Date :||December 17, 2014|
|Actual Primary Completion Date :||September 8, 2017|
|Actual Study Completion Date :||September 8, 2017|
Experimental: Iron infusion
Iron Sucrose (Venofer (R))
Drug: Iron infusion
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.
Placebo Comparator: Normal saline infusion
Equal volume to intervention of normal saline
Drug: Normal saline infusion
Normal saline (NaCl 0.9%) 5 mL/kg up to a maximum volume 210 mL
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01978535
|United States, Minnesota|
|Mayo Clinic in Rochester|
|Rochester, Minnesota, United States, 55905|
|Principal Investigator:||Amie Jones, MD||Mayo Clinic|