Abnormal Uterine Bleeding, Heavy Menstrual Bleeding, Iron Deficiency Anemia
Conditions
Brief summary
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.
Detailed description
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: * Medical history including prior hospitalizations, lab results, medications, diet, social and family history * Physical Examination * Blood samples: The patient will not have any extra blood draws (pokes) for this study. However, we will ask to take about 1/2 (0.5) teaspoons (3 mL) of extra blood for an extra research test when you have follow up blood test(s) in one month. 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.
Interventions
DRUGFerrous sulfate
Alternate day dosing of ferrous sulfate
Sponsors
Baylor College of Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
9 Years to 22 Years
Healthy volunteers
Yes
Inclusion criteria
1. Age 9 years or greater and less than age 22 years 2. Heavy menstrual bleeding, defined as a Pictorial Blood Assessment Chart (PBAC) Score \>100 3. Iron deficiency anemia, defined as both hemoglobin \<12 g/dL and ferritin \<15 ng/mL within 7 days of enrollment.
Exclusion criteria
1. non-uterine cause of vaginal bleeding 2. pregnancy 3. chronic kidney disease 4. serology confirmed celiac disease 5. active gastrointestinal blood loss 6. active malignancy 7. inability to follow-up at Texas Children's Hospital 8. receipt of intravenous iron within 30 days prior to enrollment 9. allergy or known inability to tolerate oral iron
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Eligible Patients Enrolled. | At enrollment | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Enrolled Patients Who Agree to Continue in the Study After Randomization | At enrollment | Percentage of patients who continue in study as compared to total number of enrolled patients. Information will be obtained from the study log. |
| Retention as Measured by Visit Follow-up Adherence | 12 weeks | Percentage of enrolled patients that completed 12 weeks of the study. |
| Adherence | 12 week study visit | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Daily Patients receive standard regimen of ferrous sulfate 325 mg (65 mg elemental iron) once every morning. | 7 |
| Alternate Day Patients receive ferrous sulfate 325 mg (65 mg elemental iron) once every other morning. | 6 |
| Total | 13 |
Baseline characteristics
| Characteristic | Alternate Day | Daily | Total |
|---|---|---|---|
| Age, Continuous | 16 Years | 13 Years | 14 Years |
| Hemoglobin (g/dL) | 5.7 g/dL | 6.8 g/dL | 6.3 g/dL |
| Mean Corpuscular volume (MCV, fL) | 74.9 fl | 80.8 fl | 78.5 fl |
| PBAC Score | 144 Scores of a scale | 455 Scores of a scale | 325 Scores of a scale |
| Post transfusions hemoglobin (g/dL) | 7.7 g/dL | 8.4 g/dL | 8.2 g/dL |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants | 1 Participants | 3 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) White | 3 Participants | 6 Participants | 9 Participants |
| Serum ferritin (ng/mL) | 9.5 ng/mL | 4 ng/mL | 5 ng/mL |
| Sex: Female, Male Female | 6 Participants | 7 Participants | 13 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 5 | 0 / 2 |
| other Total, other adverse events | 3 / 5 | 1 / 2 |
| serious Total, serious adverse events | 0 / 5 | 0 / 2 |
Outcome results
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.
Time frame: At enrollment
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| All Eligible Patients | Percentage of Eligible Patients Enrolled. | 13 Participants |
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.
Time frame: 12 week study visit
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| All Eligible Patients | Adherence | 65 % of pills consumed |
| Alternate Day | Adherence | 0 % of pills consumed |
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.
Time frame: At enrollment
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| All Eligible Patients | Percentage of Enrolled Patients Who Agree to Continue in the Study After Randomization | 7 Participants |
| Alternate Day | Percentage of Enrolled Patients Who Agree to Continue in the Study After Randomization | 6 Participants |
Secondary
Retention as Measured by Visit Follow-up Adherence
Percentage of enrolled patients that completed 12 weeks of the study.
Time frame: 12 weeks
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| All Eligible Patients | Retention as Measured by Visit Follow-up Adherence | 5 Participants |
| Alternate Day | Retention as Measured by Visit Follow-up Adherence | 2 Participants |