- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04594070
Daily Versus Alternate Day Iron Supplementation for the Treatment of Iron Deficiency Anemia in Pregnancy
January 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
Terminated
Intervention / Treatment
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
Interventional
Enrollment (Actual)
14
Phase
- 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
- Name: Melody Safarzadeh, MD, MS
- Phone Number: 409-772-1571
- Email: mesafarz@utmb.edu
Study Locations
-
-
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
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 |
Intervention / Treatment |
---|---|
Active Comparator: Daily iron supplementation
Oral ferrous sulfate, 325 mg, take once daily
|
Iron supplementation
|
Experimental: Alternate day iron supplementation
Oral ferrous sulfated, 650mg, taken once daily every other day
|
Iron supplementation
|
What is the study measuring?
Primary Outcome Measures
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
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.
Investigators
- 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)
October 27, 2020
Primary Completion (Actual)
January 12, 2024
Study Completion (Actual)
January 12, 2024
Study Registration Dates
First Submitted
September 30, 2020
First Submitted That Met QC Criteria
October 14, 2020
First Posted (Actual)
October 20, 2020
Study Record Updates
Last Update Posted (Actual)
January 19, 2024
Last Update Submitted That Met QC Criteria
January 18, 2024
Last Verified
January 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID 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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