Treatment Group for Non-anemic Iron Deficiency

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Non-anemic Iron Deficiency+1 More
Ferrous sulfate - Drug
Eligibility
18 - 65
Female
What conditions do you have?
Select

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.

Eligible Conditions
  • Non-anemic Iron Deficiency

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

2 Primary · 9 Secondary · Reporting Duration: 28 weeks to 36 weeks

Week 36
Third trimester hemoglobin
Day 30
Incidence of infection
Incidence of maternal hemorrhage
Incidence of preterm delivery
Incidence of treatment of anemia
Maternal anemia
Maternal hospital stay
Week 42
Hemoglobin
Day 30
Incidence of neonatal intensive care unit admission
Infant weight
Rate of poor perinatal outcome

Trial Safety

Safety Progress

1 of 3

Trial Design

2 Treatment Groups

Treatment Group
1 of 2
Placebo Group
1 of 2
Experimental Treatment
Non-Treatment Group

150 Total Participants · 2 Treatment Groups

Primary Treatment: Treatment Group · Has Placebo Group · N/A

Treatment GroupExperimental Group · 4 Interventions: Ferrous sulfate, Docusate Sodium, Prenatal, Ascorbic Acid 500Mg Tab · Intervention Types: Drug, Drug, Drug, Drug
Placebo GroupPlaceboComparator Group · 3 Interventions: Docusate Sodium, Prenatal, Placebo · Intervention Types: Drug, Drug, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ferrous sulfate
2008
Completed Phase 3
~600
Docusate Sodium
2020
Completed Phase 2
~160

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 28 weeks to 36 weeks

Who is running the clinical trial?

Stony Brook UniversityLead Sponsor
195 Previous Clinical Trials
34,523 Total Patients Enrolled

Eligibility Criteria

Age 18 - 65 · Female Participants · 5 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
Low ferritin level (<30mcg/L) in the first trimester.
You have a normal hemoglobin level in the first trimester.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 12th, 2021

Last Reviewed: October 22nd, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.