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Iron Supplement

Iron Supplementation for Iron Deficiency

N/A
Recruiting
Research Sponsored by Stony Brook University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 28 weeks to 36 weeks
Awards & highlights

Study Summary

This trialwill look into if treating iron deficiency early in pregnancy can reduce the risk of anemia in the third trimester, which can lead to complications for both mom and baby.

Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
Possible side effects include stomach upset and constipation from ferrous sulfate, while docusate sodium may help ease bowel movements. Ascorbic acid might cause indigestion or heartburn.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~28 weeks to 36 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 28 weeks to 36 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Hemoglobin
Third trimester hemoglobin
Secondary outcome measures
Incidence of infection
Incidence of maternal hemorrhage
Incidence of neonatal intensive care unit admission
+6 more

Trial Design

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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ferrous sulfate anhydrous
FDA approved
Docusate
FDA approved

Find a Location

Who is running the clinical trial?

Stony Brook UniversityLead Sponsor
216 Previous Clinical Trials
39,821 Total Patients Enrolled

Media Library

Ferrous sulfate (Iron Supplement) Clinical Trial Eligibility Overview. Trial Name: NCT05423249 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many subjects are participating in the current clinical experiment?

"Yes, clinicaltrials.gov reveals that this research project is actively looking for volunteers; it was first posted on August 12th 2022 and the most recent update occurred on October 13th 2022. 150 patients are required from 3 separate medical locations."

Answered by AI

Does this clinical investigation provide the opportunity for geriatric patients to obtain treatment?

"This medical trial accepts patients ranging from adolescents to mid-life adults, provided they are over 18 years of age."

Answered by AI

Are participants currently being accepted for enrollment in this trial?

"Affirmative. The clinicaltrials.gov website indicates that this trial is actively recruiting, having been published on August 12th 2022 and last updated on October 13th 2022. 150 participants are needed to be recruited from 3 distinct locations in order for the study to succeed."

Answered by AI

What aims are being pursued by this medical experiment?

"This trial will analyze hemoglobin levels over a 42 week period, with secondary goals of assessing infant weight at birth, NICU admission rates, maternal anemia diagnosis timing and preterm delivery rate."

Answered by AI

What are the criteria for admission into this clinical research study?

"This clinical trial seeks 150 participants who are aged 18-55 and suffer from nonanemic iron deficiency."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Treatment of Non-Anemic Iron Deficiency in Pregnancy
Kimberly Herrera 2022. "Treatment of Non-Anemic Iron Deficiency in Pregnancy". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05423249.
~7 spots leftby Jun 2024
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