Iron-deficiencyPhase 2NCT04855266
Iron Sucrose in Patients With Iron Deficiency and POTS
A Phase 2 study testing Sucrose and Tilt Table Test in people with Iron-deficiency and Postural Orthostatic Tachycardia Syndrome, run by Mayo Clinic.
Trial summary
This study aims to investigate whether the treatment of non-anemic iron deficiency with intravenous iron sucrose will result in decreased symptom reporting and improved cardiovascular indices in patients with Postural Orthostatic Tachycardia syndrome (POTS). Read more about this study
- Who is it for?
- Ages 12 years and olderHealthy volunteers can take part
- Conditions the study is for
- Iron-deficiency, Postural Orthostatic Tachycardia Syndrome
- What is being tested?
- Sucrose and Tilt Table Test
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Apr 2021to May 2023
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Patients (age 12 to years and older) with chronic (>3 months) symptoms of orthostatic intolerance, including but not limited to lightheadedness, syncope, headache, fatigue, weakness, sweating, nausea and heart palpitations.
- Symptomatic orthostatic heart rate increment ≥30 bpm if >19 years old or ≥40 bpm if <19 years old during a 10 minute 70 degree head up tilt study
- Presence of non-anemic iron deficiency, defined as serum ferritin levels <20 ug/L with hemoglobin no less than 1 gm/dL below the normal reference range as defined for age and gender
- Consent obtained from responsible guardian AND from subjects, 12-17 years of age
- Consent obtained for subjects 18 years of age and older
Who cannot join
- Orthostatic hypotension (decrease of systolic BP>30 mmHg and/or diastolic BP>15mmHg within 3 minutes of 70 degree head up tilt study)
- Pregnant or lactating females
- The presence of failure of other organ systems or systemic illness that can affect autonomic function
- Concomitant therapy with anticholinergic, alpha-adrenergic antagonists, beta-adrenergic antagonists or other medications which could interfere with autonomic testing. Patients may participate if the potentially interfering medication is held for five half-lives prior to the study
- Laboratory evidence of anemia or iron overload
- Personal history of hematochromatosis or first degree relative with hematochromatosis
- Known sensitivity to Venofer® (iron sucrose injection, USP) or other intravenous iron preparation
About this study
Official title: A Randomized, Controlled, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy of Intravenous Iron Sucrose in Patients With Non-anemic Iron Deficiency and Postural Orthostatic Tachycardia Syndrome (POTS)
This study aims to investigate whether the treatment of non-anemic iron deficiency with intravenous iron sucrose will result in decreased symptom reporting and improved cardiovascular indices in patients with Postural Orthostatic Tachycardia syndrome (POTS).
- Being tested
- Sucrose, Placebo, Tilt Table Test
- Medical subject headings
- Anemia, Iron-Deficiency, Postural Orthostatic Tachycardia Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SucroseDrug
Also called Venofer
5 mg/kg of intravenous iron sucrose (maximum dose of 200 mg). Iron sucrose will be diluted
PlaceboDrug
Normal saline (NaCl 0.9%) 5 mL/kg (maximum volume 210 mL)
Tilt Table TestDiagnostic test
A table that adjusts the body position from horizontal to vertical to simulate standing up. Heart rate and blood pressure are monitored throughout the test.
| Study group | Role | What they receive |
|---|---|---|
| Iron Sucrose Group | Experimental | Subjects will receive intravenous iron sucrose during a tilt table test Receives: Drug: Sucrose; Diagnostic Test: Tilt Table Test |
| Placebo Group | Placebo comparator | Subjects will receive intravenous placebo during a tilt table test Receives: Drug: Placebo; Diagnostic Test: Tilt Table Test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in autonomic dysfunction symptoms
Measured using the self-reported Composite Autonomic Symptom Score (COMPASS) questionnaire that asks 31 questions regarding symptoms of autonomic dysfunction
Measured: Baseline, 7 days, 6 months
Change in postural heart rate increase
Heart rate change during tilt table test measured in beats per minute
Measured: Baseline, 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2021
- Study startApr 2021 (estimated)
- Primary completionMay 2023 (estimated)
- Study completionMay 2023 (estimated)
Why it stopped: Unable to recruit participants
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Iron-deficiencyStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kamal Shouman, Mayo Clinic
- Investigators
- Kamal Shouman, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04855266
- Sponsor's protocol ID
- 21-000488
- Status last verified
- Jun 2023
- First submitted
- 19 Apr 2021
- Last updated
- 13 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Controlled, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy of Intravenous Iron Sucrose in Patients With Non-anemic Iron Deficiency and Postural Orthostatic Tachycardia Syndrome (POTS)
- ClinicalTrials.gov ID
- NCT04855266
- Acronym / sponsor ID
- 21-000488
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Unable to recruit participants
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- Apr 2021 (estimated)
- Primary completion
- May 2023 (estimated)
- Study completion
- May 2023 (estimated)
- First posted
- 22 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to investigate whether the treatment of non-anemic iron deficiency with intravenous iron sucrose will result in decreased symptom reporting and improved cardiovascular indices in patients with Postural Orthostatic Tachycardia syndrome (POTS).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Iron Sucrose Group | Experimental | Drug: Sucrose, Diagnostic Test: Tilt Table TestSubjects will receive intravenous iron sucrose during a tilt table test |
| Placebo Group | Placebo comparator | Drug: Placebo, Diagnostic Test: Tilt Table TestSubjects will receive intravenous placebo during a tilt table test |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Patients (age 12 to years and older) with chronic (>3 months) symptoms of orthostatic intolerance, including but not limited to lightheadedness, syncope, headache, fatigue, weakness, sweating, nausea and heart palpitations.
- Symptomatic orthostatic heart rate increment ≥30 bpm if >19 years old or ≥40 bpm if <19 years old during a 10 minute 70 degree head up tilt study
- Presence of non-anemic iron deficiency, defined as serum ferritin levels <20 ug/L with hemoglobin no less than 1 gm/dL below the normal reference range as defined for age and gender
- Consent obtained from responsible guardian AND from subjects, 12-17 years of age
- Consent obtained for subjects 18 years of age and older
Key exclusion criteria (7 listed)
- Orthostatic hypotension (decrease of systolic BP>30 mmHg and/or diastolic BP>15mmHg within 3 minutes of 70 degree head up tilt study)
- Pregnant or lactating females
- The presence of failure of other organ systems or systemic illness that can affect autonomic function
- Concomitant therapy with anticholinergic, alpha-adrenergic antagonists, beta-adrenergic antagonists or other medications which could interfere with autonomic testing. Patients may participate if the potentially interfering medication is held for five half-lives prior to the study
- Laboratory evidence of anemia or iron overload
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SucroseAlso: Venofer5 mg/kg of intravenous iron sucrose (maximum dose of 200 mg). Iron sucrose will be diluted | Drug | Iron Sucrose Group |
| PlaceboNormal saline (NaCl 0.9%) 5 mL/kg (maximum volume 210 mL) | Drug | Placebo Group |
| Tilt Table TestA table that adjusts the body position from horizontal to vertical to simulate standing up. Heart rate and blood pressure are monitored throughout the test. | Diagnostic test | Iron Sucrose Group, Placebo Group |
Primary outcome
Change in autonomic dysfunction symptoms
Time frame: Baseline, 7 days, 6 months
Measured using the self-reported Composite Autonomic Symptom Score (COMPASS) questionnaire that asks 31 questions regarding symptoms of autonomic dysfunction
Change in postural heart rate increase
Time frame: Baseline, 7 days
Heart rate change during tilt table test measured in beats per minute
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jun 2023.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kamal Shouman, MD principal investigator
Mayo Clinic
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Sucrose and Tilt Table Test in people with Iron-deficiency and Postural Orthostatic Tachycardia Syndrome, run by Mayo Clinic.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 13 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in autonomic dysfunction symptoms (time frame: Baseline, 7 days, 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jun 2023.