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

Primary Purpose

Pregnancy Related, Iron Deficiency Anemia of Pregnancy

Status

Recruiting

Phase

Phase 4

Locations

United States

Study Type

Interventional

Intervention

Ferrous sulfate

About this trial

This is an interventional treatment trial for Pregnancy Related focused on measuring Pregnancy, Iron deficiency, Anemia, Iron supplementation

Eligibility Criteria

18 Years - 50 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

University of Texas Medical BranchRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Daily iron supplementation

Alternate day iron supplementation

Arm Description

Oral ferrous sulfate, 325 mg, take once daily

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

Outcomes

Primary Outcome Measures

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

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

Secondary Outcome Measures

Gastrointestinal side effects after 2-4 weeks of treatment

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

Complete blood count in the third trimester

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

Serum ferritin at time of enrollment

Serum ferritin will assessed by blood draw 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.

Transferrin at time of enrollment

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

Number of participants who receive intravenous (IV) iron supplementation

By chart review, we will determine if the subject received parental (IV) iron supplementation as part of the treatment for iron deficiency anemia

Number of participants who receive a blood transfusion

By chart review, we will determine if the subject received a blood transfusion as part of the treatment for iron deficiency anemia

Postpartum hemoglobin

Hemoglobin levels after delivery will be recorded (if obtained as part of regular postpartum care)

Postpartum hematocrit

Hematocrit levels after delivery will be recorded (if obtained as part of regular postpartum care)

Neonatal weight at delivery

The weight of the baby (in grams) will be determined by chart review at the end of enrollment

Level of neonatal bilirubin at birth

Neonatal hyperbilirubinemia will be reviewed and recorded by chart review

Neonatal Apgar scores

Neonatal Apgar scores will be reviewed and recorded by chart review. The Apgar score is a method used to describe a newborn's status at birth and response to resuscitation. The Apgar score comprises five components: 1) color, 2) heart rate, 3) reflexes, 4) muscle tone, and 5) respiration, each of which is given a score of 0, 1, or 2. The range of scores is 0 to 10. Higher scores indicate reassuring newborn status.

Number of newborns who are admitted to the Neonatal Intensive Care Unit (NICU).

The need for Neonatal Intensive Care Unit (NICU) Admission, will be assessed

Weight class at time of enrollment

At time of enrollment the weight of the subject will be assessed and assigned a weight class using the World Health Organization weight classification

Full Information

NCT ID

NCT04594070

First Posted

September 30, 2020

Last Updated

April 10, 2023

Sponsor

The University of Texas Medical Branch, Galveston

1. Study Identification

Unique Protocol Identification Number

NCT04594070

Brief Title

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

Official Title

A Randomized Trial of Intermittent Oral Iron Supplementation vs. Daily Oral Iron Supplementation for the Treatment of Anemia in Pregnancy

Study Type

Interventional

2. Study Status

Record Verification Date

April 2023

Overall Recruitment Status

Recruiting

Study Start Date

October 27, 2020 (Actual)

Primary Completion Date

June 30, 2024 (Anticipated)

Study Completion Date

June 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

The University of Texas Medical Branch, Galveston

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Pregnancy Related, Iron Deficiency Anemia of Pregnancy

Keywords

Pregnancy, Iron deficiency, Anemia, Iron supplementation

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

96 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Daily iron supplementation

Arm Type

Active Comparator

Arm Description

Oral ferrous sulfate, 325 mg, take once daily

Arm Title

Alternate day iron supplementation

Arm Type

Experimental

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Ferrous sulfate

Intervention Description

Iron supplementation

Primary Outcome Measure Information:

Title

Difference in hemoglobin levels from enrollment to end of study

Description

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)

Title

Change in hematocrit in the third trimester after treatment

Description

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 Outcome Measure Information:

Title

Gastrointestinal side effects after 2-4 weeks of treatment

Description

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

Time Frame

2-4 weeks after enrollment

Title

Complete blood count in the third trimester

Description

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)

Title

Serum ferritin at time of enrollment

Description

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

Time Frame

Baseline only at time of enrollment

Title

Total iron binding capacity at time of enrollment

Description

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

Time Frame

Baseline only at time of enrollment

Title

Transferrin at time of enrollment

Description

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

Time Frame

Baseline only at time of enrollment

Title

Number of participants who receive intravenous (IV) iron supplementation

Description

By chart review, we will determine if the subject received parental (IV) iron supplementation as part of the treatment for iron deficiency anemia

Time Frame