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Iron Supplement

Sucrose for Postural Orthostatic Tachycardia Syndrome

Phase 2
Waitlist Available
Led By Kamal Shouman, MD
Research Sponsored by Mayo Clinic
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 7 days, 6 months
Awards & highlights

Study Summary

This trial will test if iron sucrose given intravenously can decrease symptoms and improve heart function in patients with POTS.

Eligible Conditions
  • Postural Orthostatic Tachycardia Syndrome
  • Iron-Deficiency Anemia

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 7 days, 6 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 7 days, 6 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in autonomic dysfunction symptoms
Change in postural heart rate increase

Side effects data

From 2010 Phase 4 trial • 141 Patients • NCT00239642
9%
Respiratory tract infection viral
6%
Renal Transplant
4%
Headache
4%
Blood pressure increased
2%
Cough
2%
Appendicitis
2%
Arteriovenous graft thrombosis
2%
Vomiting
100%
80%
60%
40%
20%
0%
Study treatment Arm
Venofer (0.5 mg/kg)
Venofer (1.0 mg/kg)
Venofer (2.0 mg/kg)

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Iron Sucrose GroupExperimental Treatment2 Interventions
Subjects will receive intravenous iron sucrose during a tilt table test
Group II: Placebo GroupPlacebo Group2 Interventions
Subjects will receive intravenous placebo during a tilt table test
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Sucrose
2008
Completed Phase 4
~1360
Tilt Table Test
2021
Completed Phase 2
~140

Find a Location

Who is running the clinical trial?

Mayo ClinicLead Sponsor
3,207 Previous Clinical Trials
3,767,140 Total Patients Enrolled
4 Trials studying Postural Orthostatic Tachycardia Syndrome
153 Patients Enrolled for Postural Orthostatic Tachycardia Syndrome
Kamal Shouman, MDPrincipal Investigator - Mayo Clinic
Mayo Clinic Rochester, Mayo HIV Clinic - Rochester

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has Sucrose met the criteria of the Food and Drug Administration?

"Our team at Power has rated the safety of Sucrose a 2 based on its Phase 2 status, indicating that there is prior evidence to suggest it is safe but no efficacy data."

Answered by AI

What afflictions has Sucrose been utilized to alleviate?

"Sucrose can be prescribed to address issues related to the oral cavity, iron levels, and dietary needs."

Answered by AI

Is this experiment currently recruiting participants?

"Evidenced by the details posted to clinicaltrials.gov, this medical study is actively recruiting volunteers with a first posting date of April 14th 2021 and most recent updates made on October 11th 2022."

Answered by AI

What is the current sample size of this experiment?

"Affirmative. The information posted on clinicaltrials.gov states that the study, which was initially released in April 2021, is currently seeking participants. This medical trial needs to enroll approximately 30 patients from a single site."

Answered by AI

What prior research has explored the potential of Sucrose?

"At the current moment, 22 trials are exploring the efficacy of Sucrose with 4 in Phase 3. Most of these clinical studies are situated in Austin, Texas; yet there is a total of 145 sites operating experiments for Sucrose around the world."

Answered by AI

Who else is applying?

What state do they live in?
Nebraska
What site did they apply to?
Mayo Clinic in Rochester
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
1

Why did patients apply to this trial?

I’ve already had an IV of iron therapy. Now my iron has gone back up. However my reticulocyte count is still currently low… otherwise I still feel tired every day. My hematologist said it is to likely come back as I am still bleeding from my nose and from my Hemorrhoids.
PatientReceived 2+ prior treatments

What questions have other patients asked about this trial?

Recent research and studies
clinicaltrials.govStudy
Iron Sucrose in Patients With Iron Deficiency and POTS
Kamal Shouman 2021. "Iron Sucrose in Patients With Iron Deficiency and POTS". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04855266.
~0 spots leftby Apr 2025
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