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Iron Supplement
Iron Supplementation Frequency for Anemia in Pregnancy
Phase 4
Waitlist Available
Led By Alan Lee, MD, MHA
Research Sponsored by The University of Texas Medical Branch, Galveston
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2-4 weeks after enrollment
Awards & highlights
Study Summary
This trial will test whether daily or every other day iron supplementation is best for pregnant women with iron deficiency anemia. Person-to-person consent needed.
Who is the study for?
This trial is for pregnant women in their first or second trimester who have iron deficiency anemia. They must have a single pregnancy and low hemoglobin levels. Women with heart/lung diseases, issues absorbing nutrients, severe anemia needing IV treatment or blood transfusion, or other types of anemia cannot join.Check my eligibility
What is being tested?
The study tests if taking iron supplements every day is more effective than taking them every other day for treating iron deficiency anemia during pregnancy. Participants will be randomly assigned to one of the two schedules after giving consent.See study design
What are the potential side effects?
Iron supplements like Ferrous sulfate can cause stomach upset, constipation, diarrhea, nausea, and dark stools. These side effects are generally mild but can vary from person to person.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2-4 weeks after enrollment
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2-4 weeks after enrollment
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in hematocrit in the third trimester after treatment
Difference in hemoglobin levels from enrollment to end of study
Secondary outcome measures
Complete blood count in the third trimester
Gastrointestinal side effects after 2-4 weeks of treatment
Level of neonatal bilirubin at birth
+11 moreSide effects data
From 2022 Phase 4 trial • 13 Patients • NCT0500789960%
Heartburn
60%
Abdominal pain
40%
Constipation
20%
Diarrhea
100%
80%
60%
40%
20%
0%
Study treatment Arm
Daily
Alternate Day
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Alternate day iron supplementationExperimental Treatment1 Intervention
Oral ferrous sulfated, 650mg, taken once daily every other day
Group II: Daily iron supplementationActive Control1 Intervention
Oral ferrous sulfate, 325 mg, take once daily
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ferrous sulfate anhydrous
FDA approved
Find a Location
Who is running the clinical trial?
The University of Texas Medical Branch, GalvestonLead Sponsor
241 Previous Clinical Trials
56,584 Total Patients Enrolled
Alan Lee, MD, MHAPrincipal InvestigatorUTMB
Melody Safarzadeh, MD, MSPrincipal InvestigatorUTMB
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You are pregnant with only one baby in the first or second trimester.You have very low red blood cell count and need a blood transfusion.Your hemoglobin level is too low during the first or second trimester of pregnancy.You have a type of anemia where your red blood cells are smaller than normal.You have anemia that is not caused by low iron levels.You have a condition that makes it hard for your body to absorb nutrients from food, or you have had a certain type of stomach surgery in the past.
Research Study Groups:
This trial has the following groups:- Group 1: Daily iron supplementation
- Group 2: Alternate day iron supplementation
Awards:
This trial has 4 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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