Alternate Day Versus Daily Oral Iron Therapy in Adolescents

Alternate Day Versus Daily Oral Iron Therapy in Adolescents With Iron Deficiency Anemia and Heavy Menstrual Bleeding: A Feasibility Trial

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.

Study Overview

• Status: Completed
• Conditions: Iron Deficiency Anemia; Heavy Menstrual Bleeding; Abnormal Uterine Bleeding
• Intervention / Treatment: Drug: Ferrous sulfate

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.

• Study Type: Interventional
• Enrollment (Actual): 13
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77030
      • Texas Children's Pavilion for Women

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 7 years to 20 years (Child, Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Daily; Patients receive standard regimen of ferrous sulfate 325 mg (65 mg elemental iron) once every morning.	Drug: Ferrous sulfate; Alternate day dosing of ferrous sulfate; Other Names: Feosol; Fer-In-Sol; Feratab; Iron
Experimental: Alternate Day; Patients receive ferrous sulfate 325 mg (65 mg elemental iron) once every other morning.	Drug: Ferrous sulfate; Alternate day dosing of ferrous sulfate; Other Names: Feosol; Fer-In-Sol; Feratab; Iron

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Baylor College of Medicine
• Investigators: Principal Investigator: Jacquelyn Powers, MD, Baylor College of Medicine

Study record dates

Study Major Dates

• Study Start (Actual): December 21, 2020
• Primary Completion (Actual): June 30, 2022
• Study Completion (Actual): December 22, 2022

Study Registration Dates

• First Submitted: July 20, 2021
• First Submitted That Met QC Criteria: August 16, 2021
• First Posted (Actual): August 17, 2021

Study Record Updates

• Last Update Posted (Actual): September 13, 2023
• Last Update Submitted That Met QC Criteria: August 29, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Metabolic Diseases; Uterine Diseases; Hematologic Diseases; Anemia, Hypochromic; Iron Metabolism Disorders; Menstruation Disturbances; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Genital Diseases, Female; Anemia, Iron-Deficiency; Hemorrhage; Anemia; Menorrhagia; Uterine Hemorrhage; Iron Deficiencies
• Other Study ID Numbers: H - 46363

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No