Trial Outcomes & Findings for Iron Sucrose in Adolescents With Iron Deficiency and Postural Orthostatic Tachycardia Syndrome (POTS) (NCT NCT01978535)

NCT ID: NCT01978535

Last Updated: 2017-11-17

Results Overview

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

• Recruitment status: TERMINATED
• Study phase: PHASE1/PHASE2
• Target enrollment: 3 participants
• Primary outcome timeframe: 7 (+/- 2) days following intervention
• Results posted on: 2017-11-17

Participant Flow

Subjects were recruited at the Mayo Clinic, Rochester, Minnesota.

Participant milestones

Measure	Iron Infusion 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 infusion: Normal saline (NaCl 0.9%) 5 mL/kg up to a maximum volume 210 mL
Overall Study STARTED	1	2
Overall Study COMPLETED	1	2
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Iron Infusion n=1 Participants 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 n=2 Participants Normal saline infusion: Normal saline (NaCl 0.9%) 5 mL/kg up to a maximum volume 210 mL	Total n=3 Participants Total of all reporting groups
Age, Categorical <=18 years	1 Participants n=1 Participants	2 Participants n=2 Participants	3 Participants n=3 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=1 Participants	0 Participants n=2 Participants	0 Participants n=3 Participants
Age, Categorical >=65 years	0 Participants n=1 Participants	0 Participants n=2 Participants	0 Participants n=3 Participants
Sex: Female, Male Female	1 Participants n=1 Participants	2 Participants n=2 Participants	3 Participants n=3 Participants
Sex: Female, Male Male	0 Participants n=1 Participants	0 Participants n=2 Participants	0 Participants n=3 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment United States	1 participants n=1 Participants	2 participants n=2 Participants	3 participants n=3 Participants

PRIMARY outcome

Timeframe: 7 (+/- 2) days following intervention

Population: The outcome measure was not analyzed because there were insufficient data.

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

Outcome measures

Outcome data not reported

Adverse Events

Iron Infusion

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Normal Saline Infusion

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Amie Jones

Mayo Clinic

Phone: 507-284-6063

Email: Jones.Amie@mayo.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place