Age: 18 - 65
Sex: Female
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: N/A
Waitlist Available
Sponsor: Stony Brook University
Approved in 4 jurisdictions
Trial Summary
What is the purpose of this trial?The objective is to investigate the treatment of non-anemic iron deficiency (NAID) and the impact on development of anemia later in pregnancy. Anemia in the third trimester has been identified as a risk factor for maternal and fetal morbidity that might lead to mortality. Due to the high incidence of NAID in pregnancy, there is an opportunity for early screening and treatment to decrease progression to anemia. The primary aim of this study is to establish if treatment of NAID will result in higher third trimester hemoglobin values and decrease incidence of anemia at term.
Eligibility Criteria
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.Treatment Details
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.
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.
Ferrous sulfate is already approved in United States, European Union, Canada, Australia for the following indications:
🇺🇸 Approved in United States as Ferrous sulfate for:
- Iron deficiency anemia
- Pregnancy-related anemia
🇪🇺 Approved in European Union as Ferrous sulfate for:
- Iron deficiency anemia
- Pregnancy-related anemia
🇨🇦 Approved in Canada as Ferrous sulfate for:
- Iron deficiency anemia
- Pregnancy-related anemia
🇦🇺 Approved in Australia as Ferrous sulfate for:
- Iron deficiency anemia
- Pregnancy-related anemia
Find a clinic near you
Research locations nearbySelect from list below to view details:
University Associates in Obstetrics & GynecologyEast Setauket, NY
University Associates in Obstetrics & GynecologyCommack, NY
University Associates in Obstetrics & GynecologyBohemia, NY
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Who is running the clinical trial?
Stony Brook UniversityLead Sponsor