Daily Versus Alternate Day Iron Supplementation for the Treatment of Iron Deficiency Anemia in Pregnancy

NCT ID: NCT04594070

Last Updated: 2024-06-24

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE4
• Total Enrollment: 14 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-10-27
• Study Completion Date: 2024-01-12

Brief Summary

The target population for our study is pregnant women in the first or second trimester with a diagnosis of iron deficiency anemia. If a subject is eligible, written consent will be obtained by person to person contact. Eligible participants will be randomized to receive either daily oral iron supplementation or every other day oral iron supplementation.

Detailed Description

Eligible pregnant women in the first or second trimester who carry a diagnosis of iron deficiency anemia as defined by the American College of Obstetrics and Gynecology will be approached, consented, and randomized to receive either daily oral ferrous sulfate (325mg) supplementation or every other day oral ferrous sulfate (650mg). Participants will undergo a phone survey 2-4 weeks after starting the study to assess for side effects. Participants will continue routine care and surveillance of iron deficiency in pregnancy until the end of pregnancy.

Conditions

Pregnancy Related; Iron Deficiency Anemia of Pregnancy

Study Design

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

Study Groups

Daily iron supplementation

Oral ferrous sulfate, 325 mg, take once daily

Group Type: ACTIVE_COMPARATOR

Ferrous sulfate

Intervention Type: DRUG

Iron supplementation

Alternate day iron supplementation

Oral ferrous sulfated, 650mg, taken once daily every other day

Group Type: EXPERIMENTAL

Ferrous sulfate

Intervention Type: DRUG

Iron supplementation

Interventions

Ferrous sulfate

Iron supplementation

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Hemoglobin less than 11 g/dl in the first trimester or less than 10.5 g/dl in the second trimester
• Microcytic anemia
• Singleton gestation in the first or second trimester

Exclusion Criteria

• Malabsorptive disorder or history of restrictive or malabsorptive gastric surgery
• Known diagnosis of anemia other than iron deficiency (thalassemia, macrocytic, sickle cell, etc.)
• History of cardiopulmonary disease
• Severe anemia requiring parental infusion or transfusion of blood products

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

The University of Texas Medical Branch, Galveston

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Melody Safarzadeh, MD, MS

Role: PRINCIPAL_INVESTIGATOR

UTMB

Locations

University of Texas Medical Branch

Galveston, Texas, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

20-0068

Identifier Type: -

Identifier Source: org_study_id