Alternate Day Versus Daily Oral Iron Therapy in Adolescents

NCT05007899 | Completed Phase 4 Results FDA Drug

• 1 other identifier: H - 46363
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

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.

Conditions

Iron Deficiency Anemia; Heavy Menstrual Bleeding; Abnormal Uterine Bleeding

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Percentage of Enrolled Patients Who Agree to Continue in the Study After Randomization

  At enrollment

• Retention as Measured by Visit Follow-up Adherence

  12 weeks

• Adherence

  12 week study visit

Study Arms (2)

Daily

ACTIVE COMPARATOR

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

Drug: Ferrous sulfate

Alternate Day

EXPERIMENTAL

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

Drug: Ferrous sulfate

Interventions

Ferrous sulfate DRUG

Alternate day dosing of ferrous sulfate

Also known as: Fer-In-Sol, Feratab, Iron, Feosol

Alternate Day; Daily

Eligibility Criteria

• Age: 9 Years - 22 Years
• Gender Eligibility Details: Must be born a female.
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Baylor College of Medicine: lead

Study Sites (1)

Texas Children's Pavilion for Women

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Anemia, Iron-Deficiency; Menorrhagia; Metrorrhagia

Interventions

ferrous sulfate; Iron; Iron-Dextran Complex

Condition Hierarchy (Ancestors)

Anemia, Hypochromic; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Iron Deficiencies; Iron Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Uterine Hemorrhage; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Menstruation Disturbances

Intervention Hierarchy (Ancestors)

Metals, Heavy; Elements; Inorganic Chemicals; Transition Elements; Metals; Coordination Complexes; Organic Chemicals; Dextrans; Glucans; Polysaccharides; Carbohydrates

Results Point of Contact

• Title: Chelsea Kebodeaux
• Organization: Nationwide Children's Hospital

Chelsea.Kebodeaux@nationwidechildrens.org

(614) 722-2250

Study Officials

• Jacquelyn Powers, MD

  Baylor College of Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: July 20, 2021
• First Posted: August 17, 2021
• Study Start: December 21, 2020
• Primary Completion: June 30, 2022
• Study Completion: December 22, 2022
• Last Updated: September 13, 2023
• Results First Posted: September 13, 2023

Record last verified: 2023-08

Locations

US (1)