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Iron Supplement
Iron Supplementation for Iron Deficiency
N/A
Recruiting
Research Sponsored by Stony Brook University
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 28 weeks to 36 weeks
Awards & highlights
Summary
This trialwill look into if treating iron deficiency early in pregnancy can reduce the risk of anemia in the third trimester, which can lead to complications for both mom and baby.
Who is the study for?
This trial is for pregnant women aged 18-55 with low iron levels but not anemic, in their first trimester (less than 20 weeks along). They must speak English and have not taken extra iron other than prenatal vitamins recently. Women can't join if they've had significant bleeding, previous conditions like SLE or HIV, or surgeries affecting digestion.
What is being tested?
The study tests whether treating non-anemic iron deficiency in early pregnancy with ferrous sulfate and additional supplements prevents anemia later on. Participants will receive either the treatment or a placebo without knowing which one to compare outcomes.
What are the potential side effects?
Possible side effects include stomach upset and constipation from ferrous sulfate, while docusate sodium may help ease bowel movements. Ascorbic acid might cause indigestion or heartburn.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 28 weeks to 36 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~28 weeks to 36 weeks
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Hemoglobin
Third trimester hemoglobin
Secondary study objectives
Incidence of infection
Incidence of maternal hemorrhage
Incidence of neonatal intensive care unit admission
+6 moreTrial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Treatment GroupExperimental Treatment4 Interventions
The treatment group will receive oral ferrous sulfate 325mg (containing 65 mg of elemental iron) once daily, an oral prenatal vitamin once daily, oral ascorbic acid 500mg once daily, and oral docusate sodium 100mg twice daily as needed.
Group II: Placebo GroupPlacebo Group3 Interventions
The placebo group will receive a placebo bill, the same oral prenatal vitamin, and oral docusate sodium 100mg twice daily as needed.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ferrous sulfate anhydrous
FDA approved
Docusate
FDA approved
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Who is running the clinical trial?
Stony Brook UniversityLead Sponsor
222 Previous Clinical Trials
41,778 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- Your ferritin level is below 30mcg/L during the first trimester of pregnancy.Women who have taken iron supplements during pregnancy, other than prenatal vitamins, within the last 3 months.Women who have had heavy vaginal bleeding before joining the study.You are less than 20 weeks pregnant.Your hemoglobin level is above 11g/dL in the first trimester of pregnancy.Women with too much iron in their body or who are highly sensitive to certain things.Women with long-term conditions like lupus, sickle cell disease, HIV, inflammatory bowel disease, ongoing cancer, or previous weight loss surgery.You are between 18 and 55 years old.Women who have low levels of red blood cells in the first three months of pregnancy.
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