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Iron deficiency anemia affects over half of girls and young women with heavy periods and is the most common cause of anemia worldwide. Most girls with heavy periods who also have iron deficiency anemia are prescribed iron to take by mouth every day by their doctor. There are some studies showing that taking iron every other day may actually help the iron be absorbed into the bloodstream better. This study is trying to compare how taking iron every other day compares to taking iron daily for treatment of anemia.
The goal of this clinical research study is to learn which of the two methods of care will be the best way for girls and young women with iron deficiency anemia to take iron supplementation.
The research will be conducted at the following location(s):
Baylor College of Medicine, TCH: Texas Children's Hospital, and TCH: Texas Children's Hospital Clinic.
If patient appears to qualify for the study they will sign and date this consent form, and the doctor will confirm that they are eligible for the study. The patient will complete the following procedures:
Patient will be on the study for 24 weeks (6 months),and will receive an information sheet about how to take iron to help it absorb in the stomach and on iron-rich foods.
There are 2 different treatments in this study. If a patient enrolls, they cannot choose which treatment to receive. Instead, they will be randomly assigned to one of the two treatments. That means there is a fifty percent chance they will receive iron medicine to take every day and a fifty percent chance they will receive iron medicine to take every other day.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Daily | Active Comparator | Patients receive standard regimen of ferrous sulfate 325 mg (65 mg elemental iron) once every morning. |
|
| Alternate Day | Experimental | Patients receive ferrous sulfate 325 mg (65 mg elemental iron) once every other morning. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ferrous sulfate | Drug | Alternate day dosing of ferrous sulfate |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Eligible Patients Enrolled. | Percentage of eligible patients who consent to be enrolled in the study. A secure screening and enrollment log will be kept. Each screened patient will be categorized as either: ineligible, eligible but not approached, eligible and enrolled, eligible and declined. If the latter (eligible and declined), the reason for declining will also be obtained and noted in the study log. | At enrollment |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Enrolled Patients Who Agree to Continue in the Study After Randomization | Percentage of patients who continue in study as compared to total number of enrolled patients. Information will be obtained from the study log. | At enrollment |
| Retention as Measured by Visit Follow-up Adherence |
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Inclusion Criteria:
Exclusion Criteria:
Must be born a female.
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| Name | Affiliation | Role |
|---|---|---|
| Jacquelyn Powers, MD | Baylor College of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Texas Children's Pavilion for Women | Houston | Texas | 77030 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Daily | Patients receive standard regimen of ferrous sulfate 325 mg (65 mg elemental iron) once every morning. |
| FG001 | Alternate Day | Patients receive ferrous sulfate 325 mg (65 mg elemental iron) once every other morning. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Daily | Patients receive standard regimen of ferrous sulfate 325 mg (65 mg elemental iron) once every morning. |
| BG001 | Alternate Day | Patients receive ferrous sulfate 325 mg (65 mg elemental iron) once every other morning. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| 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 | Percentage of Eligible Patients Enrolled. | Percentage of eligible patients who consent to be enrolled in the study. A secure screening and enrollment log will be kept. Each screened patient will be categorized as either: ineligible, eligible but not approached, eligible and enrolled, eligible and declined. If the latter (eligible and declined), the reason for declining will also be obtained and noted in the study log. | Posted | Count of Participants | Participants | At enrollment |
|
|
Twelve weeks
All-Cause Mortality, Serious Adverse Events, and Other (Gastrointestinal) Adverse Events were collected at the 12 week visit.
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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 | Daily | Patients receive standard regimen of ferrous sulfate 325 mg (65 mg elemental iron) once every morning. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Heartburn | Gastrointestinal disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chelsea Kebodeaux | Nationwide Children's Hospital | (614) 722-2250 | Chelsea.Kebodeaux@nationwidechildrens.org |
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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 | Apr 10, 2020 | Aug 29, 2023 | Prot_SAP_001.pdf |
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| ID | Term |
|---|---|
| D018798 | Anemia, Iron-Deficiency |
| D008595 | Menorrhagia |
| D008796 | Metrorrhagia |
| ID | Term |
|---|---|
| D000747 | Anemia, Hypochromic |
| D000740 | Anemia |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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| ID | Term |
|---|---|
| C020748 | ferrous sulfate |
| D007501 | Iron |
| D007505 | Iron-Dextran Complex |
| ID | Term |
|---|---|
| D019216 | Metals, Heavy |
| D004602 | Elements |
| D007287 | Inorganic Chemicals |
| D028561 | Transition Elements |
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Percentage of enrolled patients that completed 12 weeks of the study. |
| 12 weeks |
| Adherence | Pill counts were performed as an objective measure of adherence. Subjects were given a specific number of pills for the duration of the study. At the 12 week visit they were asked to return any remaining pills, which were then counted and compared to the number of expected pills should be remaining, assuming 100% adherence. These numbers were used to calculate an estimate of adherence. | 12 week study visit |
| BG002 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| PBAC Score | PBAC = Pictorial Blood Assessment Chart. The PBAC is a pictorial tool used to assess menstrual blood loss. The minimum score is 0. There is no maximum score. Higher scores are worse. A total score is reported with no subscales. An "abnormal" PBAC, which is consistent with a diagnosis of heavy menstrual bleeding is a score greater or equal to 100. | Median | Inter-Quartile Range | Scores of a scale |
|
| Hemoglobin (g/dL) | Median | Inter-Quartile Range | g/dL |
|
| Post transfusions hemoglobin (g/dL) | Median | Inter-Quartile Range | g/dL |
|
| Mean Corpuscular volume (MCV, fL) | Median | Inter-Quartile Range | fl |
|
| Serum ferritin (ng/mL) | Median | Inter-Quartile Range | ng/mL |
|
| Participants |
|
|
| Secondary | Percentage of Enrolled Patients Who Agree to Continue in the Study After Randomization | Percentage of patients who continue in study as compared to total number of enrolled patients. Information will be obtained from the study log. | Posted | Count of Participants | Participants | At enrollment |
|
|
|
| Secondary | Retention as Measured by Visit Follow-up Adherence | Percentage of enrolled patients that completed 12 weeks of the study. | Posted | Count of Participants | Participants | 12 weeks |
|
|
|
| Secondary | Adherence | Pill counts were performed as an objective measure of adherence. Subjects were given a specific number of pills for the duration of the study. At the 12 week visit they were asked to return any remaining pills, which were then counted and compared to the number of expected pills should be remaining, assuming 100% adherence. These numbers were used to calculate an estimate of adherence. | Posted | Median | Full Range | % of pills consumed | 12 week study visit |
|
|
|
| 0 |
| 5 |
| 0 |
| 5 |
| 3 |
| 5 |
| EG001 | Alternate Day | Patients receive ferrous sulfate 325 mg (65 mg elemental iron) once every other morning. | 0 | 2 | 0 | 2 | 1 | 2 |
| Abdominal pain | Gastrointestinal disorders | Systematic Assessment |
|
| Diarrhea | Gastrointestinal disorders | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | Systematic Assessment |
|
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| D000090463 |
| Iron Deficiencies |
| D019189 | Iron Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D014592 | Uterine Hemorrhage |
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D008599 | Menstruation Disturbances |
| D008670 |
| Metals |
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
| D003911 | Dextrans |
| D005936 | Glucans |
| D011134 | Polysaccharides |
| D002241 | Carbohydrates |