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

This study has been terminated.
(Difficulty in recruiting subjects.)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01978535
First Posted: November 7, 2013
Last Update Posted: November 15, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Amie E. Jones, M.D., Mayo Clinic
  Purpose
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).

Condition Intervention Phase
Postural Orthostatic Tachycardia Syndrome Drug: Iron infusion Drug: Normal saline infusion Phase 1 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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)

Resource links provided by NLM:


Further study details as provided by Amie E. Jones, M.D., Mayo Clinic:

Primary Outcome Measures:
  • 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


Enrollment: 3
Actual Study Start Date: December 17, 2014
Study Completion Date: September 8, 2017
Primary Completion Date: September 8, 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Other Names:
  • Iron sucrose
  • Venofer (TM)
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
Other Names:
  • Normal saline
  • NaCl 0.9%

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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years to 21 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

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


Locations
United States, Minnesota
Mayo Clinic in Rochester
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
Investigators
Principal Investigator: Amie Jones, MD Mayo Clinic
  Study Documents (Full-Text)

Documents provided by Amie E. Jones, M.D., Mayo Clinic:
  More Information

Responsible Party: Amie E. Jones, M.D., PI, Mayo Clinic
ClinicalTrials.gov Identifier: NCT01978535     History of Changes
Other Study ID Numbers: 12-009963
First Submitted: June 7, 2013
First Posted: November 7, 2013
Results First Submitted: October 18, 2017
Results First Posted: November 15, 2017
Last Update Posted: November 15, 2017
Last Verified: October 2017

Keywords provided by Amie E. Jones, M.D., Mayo Clinic:
POTS

Additional relevant MeSH terms:
Syndrome
Tachycardia
Postural Orthostatic Tachycardia Syndrome
Anemia, Iron-Deficiency
Disease
Pathologic Processes
Anemia, Hypochromic
Anemia
Hematologic Diseases
Iron Metabolism Disorders
Metabolic Diseases
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Orthostatic Intolerance
Primary Dysautonomias
Autonomic Nervous System Diseases
Nervous System Diseases
Iron
Ferric oxide, saccharated
Ferric Compounds
Trace Elements
Micronutrients
Growth Substances
Physiological Effects of Drugs
Hematinics