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Oral Iron Supplementation on Alternate Vs. Consecutive Days for Iron Deficiency Anemia in Pregnancy

NCT ID: NCT06492512

Last Updated: 2024-12-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE4

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-12-31

Study Completion Date

2028-06-30

Brief Summary

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This will be a randomized clinical trial. Enrolled subjects will be randomized (1:1) into two study arms to receive either daily (Group 1) or alternate day (Group 2) supplementation with one oral pill containing ferrous sulfate with an equivalent elemental iron dose of 65 mg per pill.

Detailed Description

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During the enrollment (baseline) visit, subjects will undergo a blood draw to assess hemoglobin, ferritin and soluble transferrin receptor (sTfR) levels to confirm current depleted iron stores and will then be randomly allocated into one of the two study arms. All ferrous sulfate (oral tablets) will be provided to patients by the investigators. All subjects will be instructed to take oral iron on an empty stomach or 1 hour after meals for better absorption, preferably with a vitamin C rich product such as orange juice. To minimize variability introduced by other potential iron sources, prenatal vitamins that have the same amount and form of iron will be provided to both study groups.

Conditions

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Iron-deficiency Anemia (IDA) Pregnancy

Keywords

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Iron-deficiency anemia (IDA) Iron-deficiency anemia (IDA) during gestation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomized 1:1 for daily iron (ferrous sulfate) supplementation vs. every other day iron (ferrous sulfate) supplementation
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1) Daily dose of ferrous sulfate with an equivalent elemental iron dose of 65 mg per pill

daily (Group 1) supplementation with one oral pill containing ferrous sulfate with an equivalent elemental iron dose of 65 mg per pill

Group Type EXPERIMENTAL

daily ferrous sulfate with an equivalent elemental iron dose of 65 mg per pill

Intervention Type DRUG

ferrous sulfate with an equivalent elemental iron dose of 65 mg per pill daily

2) Alternate daily dose of ferrous sulfate with an equivalent elemental iron dose of 65 mg per pill

alternate day (Group 2) supplementation with one oral pill containing ferrous sulfate with an equivalent elemental iron dose of 65 mg per pill

Group Type EXPERIMENTAL

alternate day ferrous sulfate with an equivalent elemental iron dose of 65 mg per pill

Intervention Type DRUG

ferrous sulfate with an equivalent elemental iron dose of 65 mg per pill every other day

Interventions

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daily ferrous sulfate with an equivalent elemental iron dose of 65 mg per pill

ferrous sulfate with an equivalent elemental iron dose of 65 mg per pill daily

Intervention Type DRUG

alternate day ferrous sulfate with an equivalent elemental iron dose of 65 mg per pill

ferrous sulfate with an equivalent elemental iron dose of 65 mg per pill every other day

Intervention Type DRUG

Other Intervention Names

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daily alternate day

Eligibility Criteria

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Inclusion Criteria

* Pregnant patients will be enrolled at less than 30 weeks gestational age (GA) with laboratory confirmed IDA (as defined by hemoglobin under 10.5 g/dL, as well as ferritin under 15 mcg/L)

Exclusion Criteria

* Patients \<18 years old, patients who have severe IDA that requires blood transfusion or IV iron infusion, patients who have other known hemoglobinopathy (such as thalassemia or sickle cell anemia) or anemia of different mechanism (such as vitamin B12 or folate deficiency), patients with ulcerative colitis, Crohn's disease, gastric ulcers, patients who have previously undergone gastric bypass surgery, patients who experience admission for antepartum bleed, have been diagnosed with abnormal placentation (i.e., placenta previa, placenta accreta, placenta increta or percreta)
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Southern Illinois University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Yahia Zeino, MD

Role: PRINCIPAL_INVESTIGATOR

Southern Illinois University School of Medicine

Locations

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Southern Illinois University School of Medicine

Springfield, Illinois, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Kathleen A Groesch, MS

Role: CONTACT

Phone: 217-545-6671

Email: [email protected]

Teresa S Wilson, BA

Role: CONTACT

Phone: 217-545-6711

Email: [email protected]

Facility Contacts

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Amber Fifer, Pharm D

Role: primary

Yahia Zeino, MD

Role: backup

Other Identifiers

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21-924

Identifier Type: -

Identifier Source: org_study_id