Phase 4
N=13
Alternate Day Versus Daily Oral Iron Therapy in Adolescents
Iron Deficiency Anemia · Heavy Menstrual Bleeding · Abnormal Uterine Bleeding
Bottom Line
View on ClinicalTrials.gov: NCT05007899 ↗Enrolled (actual)
13
Serious AEs
0.0%
Results posted
Sep 2023
Primary outcome: Primary: Percentage of Eligible Patients Enrolled. — 13 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Ferrous sulfate (Drug)
- Age
- Pediatric, Adult · 9+ yrs
- Sex
- Female
- Sponsor
- Baylor College of Medicine
- Primary completion
- Jun 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Eligible Patients Enrolled. |
13 | — |
| SECONDARY Percentage of Enrolled Patients Who Agree to Continue in the Study After Randomization |
7; 6 | — |
| SECONDARY Retention as Measured by Visit Follow-up Adherence |
5; 2 | — |
| SECONDARY Adherence |
65; 0 | — |
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.
Eligibility Criteria
Inclusion Criteria
- Age 9 years or greater and less than age 22 years
- Heavy menstrual bleeding, defined as a Pictorial Blood Assessment Chart (PBAC) Score >100
- Iron deficiency anemia, defined as both hemoglobin <12 g/dL and ferritin <15 ng/mL within 7 days of enrollment.
Exclusion Criteria
- non-uterine cause of vaginal bleeding
- pregnancy
- chronic kidney disease
- serology confirmed celiac disease
- active gastrointestinal blood loss
- active malignancy
- inability to follow-up at Texas Children's Hospital
- receipt of intravenous iron within 30 days prior to enrollment
- allergy or known inability to tolerate oral iron
Data sourced from ClinicalTrials.gov (NCT05007899). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.