Texas Children's Pavilion for Women
Houston, Texas, 77030, United States
NCT Number: NCT05007899
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.
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Notify Me9 year–22 year
Female
Interventional
Phase 4
Houston, Texas, 77030, United States
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Alternate day dosing of ferrous sulfate
Other names: Fer-In-Sol, Feratab, Iron, Feosol
Time frame: 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.
Time frame: 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.
Time frame: 12 weeks
Percentage of enrolled patients that completed 12 weeks of the study.
Time frame: 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.
Baylor College of Medicine
Other
Alternate Day Versus Daily Oral Iron Therapy in Adolescents With Iron Deficiency Anemia and Heavy Menstrual Bleeding: A Feasibility Trial
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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