Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 5 of 61 for:    "Postural Orthostatic Tachycardia Syndrome"

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

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.
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
Sponsor:
Information provided by (Responsible Party):
Amie E. Jones, M.D., Mayo Clinic

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Postural Orthostatic Tachycardia Syndrome
Interventions Drug: Iron infusion
Drug: Normal saline infusion
Enrollment 3
Recruitment Details Subjects were recruited at the Mayo Clinic, Rochester, Minnesota.
Pre-assignment Details  
Arm/Group Title Iron Infusion Normal Saline Infusion
Hide Arm/Group Description 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. Normal saline infusion: Normal saline (NaCl 0.9%) 5 mL/kg up to a maximum volume 210 mL
Period Title: Overall Study
Started 1 2
Completed 1 2
Not Completed 0 0
Arm/Group Title Iron Infusion Normal Saline Infusion Total
Hide Arm/Group Description 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. Normal saline infusion: Normal saline (NaCl 0.9%) 5 mL/kg up to a maximum volume 210 mL Total of all reporting groups
Overall Number of Baseline Participants 1 2 3
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1 participants 2 participants 3 participants
<=18 years
1
 100.0%
2
 100.0%
3
 100.0%
Between 18 and 65 years
0
   0.0%
0
   0.0%
0
   0.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1 participants 2 participants 3 participants
Female
1
 100.0%
2
 100.0%
3
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
Race and Ethnicity Not Collected   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 0 participants 0 participants 0 participants
0
[1]
Measure Analysis Population Description: Race and Ethnicity were not collected from any participant.
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 1 participants 2 participants 3 participants
1 2 3
1.Primary Outcome
Title Cardiovascular Indices-interval Change in Heart Rate During 10-minute Head up Tilt Table Test
Hide Description 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
Time Frame 7 (+/- 2) days following intervention
Hide Outcome Measure Data
Hide Analysis Population Description
The outcome measure was not analyzed because there were insufficient data.
Arm/Group Title Iron Infusion Normal Saline Infusion
Hide Arm/Group Description:
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.
Normal saline infusion: Normal saline (NaCl 0.9%) 5 mL/kg up to a maximum volume 210 mL
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame Six months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Iron Infusion Normal Saline Infusion
Hide Arm/Group Description 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. Normal saline infusion: Normal saline (NaCl 0.9%) 5 mL/kg up to a maximum volume 210 mL
All-Cause Mortality
Iron Infusion Normal Saline Infusion
Affected / at Risk (%) Affected / at Risk (%)
Total   0/1 (0.00%)   0/2 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Iron Infusion Normal Saline Infusion
Affected / at Risk (%) Affected / at Risk (%)
Total   0/1 (0.00%)   0/2 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Iron Infusion Normal Saline Infusion
Affected / at Risk (%) Affected / at Risk (%)
Total   0/1 (0.00%)   0/2 (0.00%) 
The study was terminated early due to difficulty in recruiting subjects.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Dr. Amie Jones
Organization: Mayo Clinic
Phone: 507-284-6063
Responsible Party: Amie E. Jones, M.D., 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 17, 2017
Last Update Posted: November 17, 2017