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

NCT01978535 | Terminated Phase 1 Results

• 1 other identifier: 12-009963
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Postural Orthostatic Tachycardia Syndrome

Keywords

POTS

Outcome Measures

Primary Outcomes (1)

• Cardiovascular Indices-interval Change in Heart Rate During 10-minute Head up Tilt Table Test

  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

  7 (+/- 2) days following intervention

Study Arms (2)

Iron infusion

EXPERIMENTAL

Iron Sucrose (Venofer (R))

Drug: Iron infusion

Normal saline infusion

PLACEBO COMPARATOR

Equal volume to intervention of normal saline

Drug: Normal saline infusion

Interventions

Iron infusion DRUG

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.

Also known as: Iron sucrose, Venofer (TM)

Iron infusion

Normal saline infusion DRUG

Normal saline (NaCl 0.9%) 5 mL/kg up to a maximum volume 210 mL

Also known as: Normal saline, NaCl 0.9%

Normal saline infusion

Eligibility Criteria

• Age: 12 Years - 21 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

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

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

MeSH Terms

Conditions

Postural Orthostatic Tachycardia Syndrome

Interventions

Ferric Oxide, Saccharated; Saline Solution; Sodium Chloride

Condition Hierarchy (Ancestors)

Orthostatic Intolerance; Primary Dysautonomias; Autonomic Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Ferric Compounds; Iron Compounds; Inorganic Chemicals; Glucaric Acid; Sugar Acids; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Hydroxy Acids; Carbohydrates; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations; Chlorides; Hydrochloric Acid; Chlorine Compounds; Sodium Compounds

Limitations and Caveats

The study was terminated early due to difficulty in recruiting subjects.

Results Point of Contact

• Title: Dr. Amie Jones
• Organization: Mayo Clinic

Jones.Amie@mayo.edu

507-284-6063

Study Officials

• Amie Jones, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PI

Study Record Dates

• First Submitted: June 7, 2013
• First Posted: November 7, 2013
• Study Start: December 17, 2014
• Primary Completion: September 8, 2017
• Study Completion: September 8, 2017
• Last Updated: November 17, 2017
• Results First Posted: November 17, 2017

Record last verified: 2017-10

Locations

US (1)