Treatment of Non-Anemic Iron Deficiency in Pregnancy

NCT05423249 | Completed

• 1 other identifier: IRB2022-00121
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 3

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.

Conditions

Non-anemic Iron Deficiency

Outcome Measures

Primary Outcomes (2)

• Delivery admission hemoglobin

  hemoglobin value \<11 mg/dL

  From date of randomization until to 42 weeks

• Third trimester hemoglobin

  Incidence of anemia, hemoglobin value \<11 mg/dL, in the third trimester

  28 weeks to 36 weeks

Secondary Outcomes (9)

• Maternal anemia

  Enrollment to 30 days postpartum

• Incidence of preterm delivery

  Enrollment to 30 days postpartum

• Incidence of maternal hemorrhage

  Enrollment to 30 days postpartum

• Incidence of treatment of anemia

  Enrollment to 30 days postpartum

• Incidence of infection

  Enrollment to 30 days postpartum

Study Arms (2)

Treatment Group

EXPERIMENTAL

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.

Drug: Ferrous sulfate; Drug: Prenatal; Drug: Docusate Sodium; Drug: Ascorbic Acid 500Mg Tab

Placebo Group

PLACEBO COMPARATOR

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

Drug: Prenatal; Drug: Docusate Sodium; Drug: Placebo

Interventions

Ferrous sulfate DRUG

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

Treatment Group

Prenatal DRUG

Oral prenatal vitamin once daily for both groups

Placebo Group; Treatment Group

Docusate Sodium DRUG

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

Placebo Group; Treatment Group

Ascorbic Acid 500Mg Tab DRUG

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

Treatment Group

Placebo DRUG

Oral placebo pill once daily

Placebo Group

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Stony Brook University: lead

Study Sites (3)

University Associates in Obstetrics & Gynecology

Bohemia, New York, 11716, United States

Location

University Associates in Obstetrics & Gynecology

Commack, New York, 11725, United States

Location

University Associates in Obstetrics & Gynecology

East Setauket, New York, 11733, United States

Location

MeSH Terms

Conditions

Iron Deficiencies

Interventions

ferrous sulfate; Prenatal Care; Dioctyl Sulfosuccinic Acid; Ascorbic Acid

Condition Hierarchy (Ancestors)

Iron Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Patient Care; Therapeutics; Maternal Health Services; Community Health Services; Health Services; Health Care Facilities Workforce and Services; Succinates; Dicarboxylic Acids; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Sugar Acids; Hydroxy Acids; Carbohydrates

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Assistant Professor and Associate Maternal Fetal Medicine Fellowship Director

Study Record Dates

• First Submitted: May 19, 2022
• First Posted: June 21, 2022
• Study Start: August 12, 2022
• Primary Completion: November 1, 2024
• Study Completion: November 15, 2024
• Last Updated: November 29, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)