Treatment of Non-Anemic Iron Deficiency in Pregnancy

NCT ID: NCT05423249

Last Updated: 2024-11-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-08-12
• Study Completion Date: 2024-11-15

Brief Summary

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.

Detailed Description

All women who fit the inclusion criteria will be approached to be recruited for participation at Stony Brook University Hospital outpatient clinic at less than 20 weeks gestational age. Women who agree to participate in the study will be consented. The study team member will obtain consent from participants and randomize the patient into either the treatment or placebo group based on a 1:1 randomization scheme generated by randomization.com. The study team member will remain blinded, as randomization of subjects will be coordinated by departmental research coordinator, who will not have any interaction with subjects. The treatment group will receive oral ferrous sulfate 325mg (containing 65 mg of elemental iron) daily and a prenatal vitamin, and the placebo group will receive prenatal vitamin and a placebo pill. The prenatal vitamin, which contains iron, will be the same exact formula and will be given to all participants in both control and treatment groups. Only the treatment group will receive the extra iron supplement. The treatment group will also receive vitamin C 500mg daily to assist with iron absorption. Both groups will receive oral docusate sodium (Colace) 100mg twice daily as needed to decrease the risk of constipation.

The randomization will be blinded to the participant, along with the medical provider and study team. Since the Research Pharmacy is able to combine the iron and Vitamin C into one pill, and both groups will receive Colace and prenatal vitamin, the total pill count will not differ from the treatment group and placebo group.

Patients who agree to participate in the study will continue with routine prenatal care and testing, which includes a repeat complete blood count (CBC) in both the second and third trimester, at approximately 24-28 weeks and 34-36 weeks, as is standard of care. In the second and third trimester, a questionnaire will be given to the subject to assess fatigue scores, experience of side effects and severity of side effects. At that time, a study team member will also perform a pill count to assess for compliance.

At time of admission to the hospital for delivery, a repeat ferritin level will be drawn with routine lab work, including a CBC, with no additional risk of blood draw to the patient as this is part of standard of care. The ferritin test will be for research purposes for the study, but will not require an additional blood draw. Clinical anemia will be defined as a hemoglobin level less than or equal to 11 g/dL. While there is no normative data in the literature on ferritin levels in pregnancy, we will define a low ferritin level as <30 mcg/L based on both retrospective pregnancy data and standardized ferritin levels in the non pregnant patient population.

Conditions

Non-anemic Iron Deficiency

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Treatment Group

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 Type: EXPERIMENTAL

Ferrous sulfate

Intervention Type: DRUG

Oral ferrous sulfate 325 mg once daily, containing 65 mg of elemental iron to treat non-anemic iron deficiency

Prenatal

Intervention Type: DRUG

Oral prenatal vitamin once daily for both groups

Docusate Sodium

Intervention Type: DRUG

Oral docusate sodium 100 mg twice daily as needed, to treat constipation secondary to oral iron supplementation

Ascorbic Acid 500Mg Tab

Intervention Type: DRUG

Oral ascorbic acid 500 mg daily, to improve absorption of oral iron

Placebo Group

The placebo group will receive a placebo bill, the same oral prenatal vitamin, and oral docusate sodium 100mg twice daily as needed.

Group Type: PLACEBO_COMPARATOR

Prenatal

Intervention Type: DRUG

Oral prenatal vitamin once daily for both groups

Docusate Sodium

Intervention Type: DRUG

Oral docusate sodium 100 mg twice daily as needed, to treat constipation secondary to oral iron supplementation

Placebo

Intervention Type: DRUG

Oral placebo pill once daily

Interventions

Ferrous sulfate

Oral ferrous sulfate 325 mg once daily, containing 65 mg of elemental iron to treat non-anemic iron deficiency

Intervention Type: DRUG

Prenatal

Oral prenatal vitamin once daily for both groups

Intervention Type: DRUG

Docusate Sodium

Oral docusate sodium 100 mg twice daily as needed, to treat constipation secondary to oral iron supplementation

Intervention Type: DRUG

Ascorbic Acid 500Mg Tab

Oral ascorbic acid 500 mg daily, to improve absorption of oral iron

Intervention Type: DRUG

Placebo

Oral placebo pill once daily

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• English speaking
• age 18-55
• less than 20 weeks gestational age
• low ferritin level (<30mcg/L) in the first trimester
• normal hemoglobin level (>11g/dL) in the first trimester

Exclusion Criteria

• Women with anemia diagnosed in the first trimester (HgB ≤11 g/dL)
• Women with antepartum iron supplementation, except prenatal vitamin, within 3 months
• Women with iron overload or hypersensitivity
• Women with significant vaginal bleeding prior to enrollment
• Women with chronic illness: SLE, hemoglobinopathies, HIV, inflammatory bowel disease, active cancer, prior bariatric surgery

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Stony Brook University

OTHER

Sponsor Role: lead

Responsible Party

Kimberly Herrera

Clinical Assistant Professor and Associate Maternal Fetal Medicine Fellowship Director

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

University Associates in Obstetrics & Gynecology

Bohemia, New York, United States

University Associates in Obstetrics & Gynecology

Commack, New York, United States

University Associates in Obstetrics & Gynecology

East Setauket, New York, United States

Countries

United States

Other Identifiers

IRB2022-00121

Identifier Type: -

Identifier Source: org_study_id