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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Iron Sucrose Group | Experimental | Subjects will receive intravenous iron sucrose during a tilt table test |
|
| Placebo Group | Placebo Comparator | Subjects will receive intravenous placebo during a tilt table test |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sucrose | Drug | 5 mg/kg of intravenous iron sucrose (maximum dose of 200 mg). Iron sucrose will be diluted |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Baseline, 7 days, 6 months |
| Change in postural heart rate increase | Heart rate change during tilt table test measured in beats per minute | Baseline, 7 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kamal Shouman, MD | Mayo Clinic | Principal Investigator |
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| Label | URL |
|---|---|
| Mayo Clinic Clinical Trials | View source |
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| ID | Term |
|---|---|
| D018798 | Anemia, Iron-Deficiency |
| D054972 | Postural Orthostatic Tachycardia Syndrome |
| ID | Term |
|---|---|
| D000747 | Anemia, Hypochromic |
| D000740 | Anemia |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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| ID | Term |
|---|---|
| D013395 | Sucrose |
| D000077605 | Ferric Oxide, Saccharated |
| D018667 | Tilt-Table Test |
| ID | Term |
|---|---|
| D004187 | Disaccharides |
| D009844 | Oligosaccharides |
| D011134 | Polysaccharides |
| D002241 | Carbohydrates |
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| Placebo | Drug | Normal saline (NaCl 0.9%) 5 mL/kg (maximum volume 210 mL) |
|
| Tilt Table Test | Diagnostic 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. |
|
| D000090463 |
| Iron Deficiencies |
| D019189 | Iron Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D054971 | Orthostatic Intolerance |
| D054969 | Primary Dysautonomias |
| D001342 | Autonomic Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D000073893 |
| Sugars |
| D005290 | Ferric Compounds |
| D058085 | Iron Compounds |
| D007287 | Inorganic Chemicals |
| D005937 | Glucaric Acid |
| D013400 | Sugar Acids |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
| D006880 | Hydroxy Acids |
| D003935 | Diagnostic Techniques, Cardiovascular |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |