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Change in personnel and lack of resources to continue.
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The purpose of this research study is to see if the level of serum ferritin differs based on how often oral iron (in the form of ferrous sulfate) is given to children with restless leg syndrome/periodic limb movement disorder.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ferrous sulfate daily | Active Comparator | Subject will take 3 mg/kg oral iron in the morning |
|
| Ferrous sulfate twice daily | Active Comparator | Subjects will take 1.5 mg/kg oral iron twice daily |
|
| Ferrous sulfate every other day | Active Comparator | 6 mg/kg oral iron every other day in the morning |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ferrous sulfate | Drug | Guideline-recommended 3 mg/kg/day dosing |
|
| Measure | Description | Time Frame |
|---|---|---|
| Ferritin Level | Ferritin level in blood measured in micrograms per liter | 2 months |
| Side Effects | Number of subjects to experience side effects effects (e.g., stool color change, nausea, constipation, teeth staining) | 2 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Julie Baughn, MD | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic in Rochester | Rochester | Minnesota | 55905 | United States |
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| Label | URL |
|---|---|
| Mayo Clinic Clinical Trials | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Ferrous Sulfate Daily | Subject will take 3 mg/kg oral iron in the morning Ferrous sulfate: Guideline-recommended 3 mg/kg/day dosing |
| FG001 | Ferrous Sulfate Twice Daily | Subjects will take 1.5 mg/kg oral iron twice daily Ferrous sulfate: Guideline-recommended 3 mg/kg/day dosing |
| FG002 | Ferrous Sulfate Every Other Day | 6 mg/kg oral iron every other day in the morning Ferrous sulfate: Guideline-recommended 3 mg/kg/day dosing |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Ferrous Sulfate Daily | Subject will take 3 mg/kg oral iron in the morning Ferrous sulfate: Guideline-recommended 3 mg/kg/day dosing |
| BG001 | Ferrous Sulfate Twice Daily | Subjects will take 1.5 mg/kg oral iron twice daily Ferrous sulfate: Guideline-recommended 3 mg/kg/day dosing |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Ferritin Level | Ferritin level in blood measured in micrograms per liter | Ferritin level at 2 months was not collected for 4 participants. | Posted | Number | mcg/L | 2 months |
|
Adverse events were collected from baseline to end of study participation for a total of approximately 2 months after starting ferrous sulfate on all participants.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Ferrous Sulfate Daily | Subject will take 3 mg/kg oral iron in the morning Ferrous sulfate: Guideline-recommended 3 mg/kg/day dosing |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea/GI Upset | Gastrointestinal disorders | Systematic Assessment |
Study terminated due to change in personnel and lack of resources to continue.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Julie M. Baughn, M.D. | Mayo Clinic | 507-293-1031 | Baughn.Julie@mayo.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 2, 2021 | Apr 23, 2024 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D012893 | Sleep Wake Disorders |
| D012148 | Restless Legs Syndrome |
| D018798 | Anemia, Iron-Deficiency |
| ID | Term |
|---|---|
| D009422 | Nervous System Diseases |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C020748 | ferrous sulfate |
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| BG002 | Ferrous Sulfate Every Other Day | 6 mg/kg oral iron every other day in the morning Ferrous sulfate: Guideline-recommended 3 mg/kg/day dosing |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
6 mg/kg oral iron every other day in the morning Ferrous sulfate: Guideline-recommended 3 mg/kg/day dosing |
|
|
| Primary | Side Effects | Number of subjects to experience side effects effects (e.g., stool color change, nausea, constipation, teeth staining) | Posted | Count of Participants | Participants | 2 months |
|
|
|
| 0 |
| 1 |
| 0 |
| 1 |
| 1 |
| 1 |
| EG001 | Ferrous Sulfate Twice Daily | Subjects will take 1.5 mg/kg oral iron twice daily Ferrous sulfate: Guideline-recommended 3 mg/kg/day dosing | 0 | 2 | 0 | 2 | 1 | 2 |
| EG002 | Ferrous Sulfate Every Other Day | 6 mg/kg oral iron every other day in the morning Ferrous sulfate: Guideline-recommended 3 mg/kg/day dosing | 0 | 3 | 0 | 3 | 0 | 3 |
| Constipation | Gastrointestinal disorders | Systematic Assessment |
|
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| D001523 | Mental Disorders |
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D020447 | Parasomnias |
| D000747 | Anemia, Hypochromic |
| D000740 | Anemia |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D000090463 | Iron Deficiencies |
| D019189 | Iron Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| Between 18 and 65 years |
|
| >=65 years |
|
| Male |
|