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

Phase 4TerminatedNCT04594070

The University of Texas Medical Branch, Galveston14 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Interventions

Ferrous sulfateDRUG

Iron supplementation

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 50 Years

Medical Language ↔ Plain English

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

Locations (1)

University of Texas Medical Branch

Galveston, Texas, United States

Outcomes

Primary Outcomes

Difference in Hemoglobin Levels From Enrollment to End of Study

Hemoglobin levels will be assessed by blood draw upon enrollment and again in the third trimester of pregnancy

Time frame: Baseline and again 8-9 months later (third trimester of pregnancy)

Change in Hematocrit in the Third Trimester After Treatment

Hematocrit levels will be assessed by blood draw upon enrollment and again in the third trimester of pregnancy

Time frame: Baseline and again 8-9 months later (third trimester of pregnancy)

Secondary Outcomes

Gastrointestinal Side Effects After 2-4 Weeks of Treatment

Gastrointestinal side effects with treatment will be assessed by telephone survey using a validated questionnaire.

Time frame: 2-4 weeks after enrollment

Complete Blood Count in the Third Trimester

Complete blood count indices will be assessed by blood draw upon enrollment and approximately monthly until delivery

Time frame: 8-9 months after enrollment (third trimester of pregnancy)

Serum Ferritin at Time of Enrollment

Serum ferritin will assessed by blood draw at time of enrollment.

Time frame: Baseline only at time of enrollment

Total Iron Binding Capacity at Time of Enrollment

Total iron binding capacity will assessed by blood draw at time of enrollment.

Time frame: Baseline only at time of enrollment

Transferrin at Time of Enrollment

Transferrin levels will assessed by blood draw at time of enrollment.

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.