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Treatment of Non-Anemic Iron Deficiency in Pregnancy

NCT05423249 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2024-11-29

No results posted yet for this study

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

Interventions

DRUG

Ferrous sulfate

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

DRUG

Prenatal

Oral prenatal vitamin once daily for both groups

DRUG

Docusate Sodium

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

DRUG

Ascorbic Acid 500Mg Tab

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

DRUG

Placebo

Oral placebo pill once daily

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-08-12
Primary Completion
2024-11-01
Completion
2024-11-15

Countries

  • United States

Study Locations

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Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05423249 on ClinicalTrials.gov