Alternate Day Versus Daily Oral Iron Therapy in Adolescents

NCT ID: NCT05007899

Last Updated: 2023-09-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 13 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-12-21
• Study Completion Date: 2022-12-22

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.

Conditions

Iron Deficiency Anemia; Heavy Menstrual Bleeding; Abnormal Uterine Bleeding

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Daily

Patients receive standard regimen of ferrous sulfate 325 mg (65 mg elemental iron) once every morning.

Group Type: ACTIVE_COMPARATOR

Ferrous sulfate

Intervention Type: DRUG

Alternate day dosing of ferrous sulfate

Alternate Day

Patients receive ferrous sulfate 325 mg (65 mg elemental iron) once every other morning.

Group Type: EXPERIMENTAL

Ferrous sulfate

Intervention Type: DRUG

Alternate day dosing of ferrous sulfate

Interventions

Ferrous sulfate

Alternate day dosing of ferrous sulfate

Intervention Type: DRUG

Other Intervention Names

Fer-In-Sol; Feratab; Iron; Feosol

Eligibility Criteria

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

• Minimum Eligible Age: 9 Years
• Maximum Eligible Age: 22 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Baylor College of Medicine

OTHER

Sponsor Role: lead

Responsible Party

Jacquelyn Powers, MD, MS

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jacquelyn Powers, MD

Role: PRINCIPAL_INVESTIGATOR

Baylor College of Medicine

Locations

Texas Children's Pavilion for Women

Houston, Texas, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

H - 46363

Identifier Type: -

Identifier Source: org_study_id