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

June 18, 2024 updated by: The University of Texas Medical Branch, Galveston

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
14

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Melody Safarzadeh, MD, MS
  • Phone Number: 409-772-1571
  • Email: mesafarz@utmb.edu

Study Locations

  • United States
    • Texas
      • Galveston, Texas, United States, 77555
        • University of Texas Medical Branch

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Daily iron supplementation
Oral ferrous sulfate, 325 mg, take once daily
Drug: Ferrous sulfate
Iron supplementation
Experimental: Alternate day iron supplementation
Oral ferrous sulfated, 650mg, taken once daily every other day
Drug: Ferrous sulfate
Iron supplementation

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Difference in Hemoglobin Levels From Enrollment to End of Study
Time Frame: Baseline and again 8-9 months later (third trimester of pregnancy)
Hemoglobin levels will be assessed by blood draw upon enrollment and again in the third trimester of pregnancy
Baseline and again 8-9 months later (third trimester of pregnancy)
Change in Hematocrit in the Third Trimester After Treatment
Time Frame: Baseline and again 8-9 months later (third trimester of pregnancy)
Hematocrit levels will be assessed by blood draw upon enrollment and again in the third trimester of pregnancy
Baseline and again 8-9 months later (third trimester of pregnancy)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Gastrointestinal Side Effects After 2-4 Weeks of Treatment
Time Frame: 2-4 weeks after enrollment
Gastrointestinal side effects with treatment will be assessed by telephone survey using a validated questionnaire.
2-4 weeks after enrollment
Complete Blood Count in the Third Trimester
Time Frame: 8-9 months after enrollment (third trimester of pregnancy)
Complete blood count indices will be assessed by blood draw upon enrollment and approximately monthly until delivery
8-9 months after enrollment (third trimester of pregnancy)
Serum Ferritin at Time of Enrollment
Time Frame: Baseline only at time of enrollment
Serum ferritin will assessed by blood draw at time of enrollment.
Baseline only at time of enrollment
Total Iron Binding Capacity at Time of Enrollment
Time Frame: Baseline only at time of enrollment
Total iron binding capacity will assessed by blood draw at time of enrollment.
Baseline only at time of enrollment
Transferrin at Time of Enrollment
Time Frame: Baseline only at time of enrollment
Transferrin levels will assessed by blood draw at time of enrollment.
Baseline only at time of enrollment
Number of Participants Who Receive Intravenous (IV) Iron Supplementation
Time Frame: At completion of study, on average after 9 months
By chart review, we will determine if the subject received parental (IV) iron supplementation as part of the treatment for iron deficiency anemia
At completion of study, on average after 9 months
Number of Participants Who Receive a Blood Transfusion
Time Frame: At completion of study, on average after 9 months
By chart review, we will determine if the subject received a blood transfusion as part of the treatment for iron deficiency anemia
At completion of study, on average after 9 months
Postpartum Hemoglobin
Time Frame: At completion of study, on average after 9 months
Hemoglobin levels after delivery will be recorded (if obtained as part of regular postpartum care)
At completion of study, on average after 9 months
Postpartum Hematocrit
Time Frame: At completion of study, on average after 9 months
Hematocrit levels after delivery will be recorded (if obtained as part of regular postpartum care)
At completion of study, on average after 9 months
Neonatal Weight at Delivery
Time Frame: At completion of study, on average after 9 months
The weight of the baby (in grams) will be determined by chart review at the end of enrollment
At completion of study, on average after 9 months
Level of Neonatal Bilirubin at Birth
Time Frame: At completion of study, on average after 9 months
Neonatal hyperbilirubinemia will be reviewed and recorded by chart review
At completion of study, on average after 9 months
Neonatal Apgar Scores
Time Frame: At completion of study, on average after 9 months
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.
At completion of study, on average after 9 months
Number of Newborns Who Are Admitted to the Neonatal Intensive Care Unit (NICU).
Time Frame: At completion of study, on average after 9 months
The need for Neonatal Intensive Care Unit (NICU) Admission, will be assessed
At completion of study, on average after 9 months
Weight Class at Time of Enrollment
Time Frame: Baseline only 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
Baseline only at time of enrollment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
The University of Texas Medical Branch, Galveston

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Melody Safarzadeh, MD, MS, UTMB

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 27, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 12, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 12, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 30, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 14, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 20, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 24, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 18, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 20-0068

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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