We updated the design of this site on September 25th. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

This study is currently recruiting participants.
Verified September 2016 by Amie E. Jones, M.D., Mayo Clinic
Sponsor:
ClinicalTrials.gov Identifier:
NCT01978535
First Posted: November 7, 2013
Last Update Posted: September 19, 2016
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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. 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-Intraval 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 intraval of measured heart rate change, during a ten minute head up tilt, in adolescent subjects with POTS and non-anemic iron deficiency


Estimated Enrollment: 30
Study Start Date: October 2013
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: December 2016 (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%

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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 Recruiting
Rochester, Minnesota, United States, 55905
Contact: Tonette Gehrking    507-284-4462      
Sponsors and Collaborators
Mayo Clinic
Investigators
Principal Investigator: Amie Jones, MD 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
Last Update Posted: September 19, 2016
Last Verified: September 2016

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


To Top