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Iron Supplement

Intravenous iron for Iron-Deficiency Anemia (IDA Trial)

Phase 3

Recruiting

Research Sponsored by Arrowhead Regional Medical Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up duration of the pregnancy (up to 40 weeks) and up to 2 months postpartum

Awards & highlights

IDA Trial Summary

This trial aims to see if giving pregnant women with low iron levels intravenous iron early in pregnancy is better than the standard oral iron treatment. Women with low iron levels were randomly given either oral or intr

Who is the study for?

This trial is for pregnant individuals with iron deficiency anemia. Participants must have a confirmed diagnosis and be at a stage in their pregnancy where they can safely receive treatment. There's no mention of specific exclusion criteria provided, so it's unclear who might not qualify.Check my eligibility

What is being tested?

The study compares two ways to treat iron deficiency anemia in pregnancy: one group receives Venofer (an intravenous iron injection), while the other takes Ferrous sulfate (oral iron tablets). Patients are randomly chosen for either method and monitored over time to see which is more effective.See study design

What are the potential side effects?

Potential side effects of Venofer may include taste changes, dizziness, high blood pressure, or pain at the injection site. Oral Ferrous sulfate could cause stomach upset, constipation, diarrhea, or dark stools.

IDA Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ duration of the pregnancy (up to 40 weeks) and up to 2 months postpartum

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~duration of the pregnancy (up to 40 weeks) and up to 2 months postpartum

This trial's timeline: 3 weeks for screening, Varies for treatment, and duration of the pregnancy (up to 40 weeks) and up to 2 months postpartum for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Delivery Hemoglobin

Ferritin difference

Hemoglobin difference

+2 more

Secondary outcome measures

Birthweight

Depression

Preterm delivery

IDA Trial Design

2Treatment groups

Active Control

Placebo Group

Group I: Intravenous ironActive Control1 Intervention

Venofer 200 mg will be given every other day until the patient reaches their calculated in deficit dose. The does of IV iron will be calculated according to the Ganzoni formula: total iron dose (mg) = body weight (kg) x (target Hgb - baseline Hgb (g/dL)) × 0.24 + 500 mg.14 Our target Hgb will be 11.0 g/dL. The determination of the treatment duration and dosage will be based on the calculation of the iron deficit.

Group II: Oral ironPlacebo Group1 Intervention

Ferrous sulfate 325 mg orally every other day on an empty stomach with lemon/orange water until delivery.

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Arrowhead Regional Medical CenterLead Sponsor

14 Previous Clinical Trials

6,415 Total Patients Enrolled

Frequently Asked Questions

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

Are new participants currently being accepted for enrollment in this ongoing medical study?

"According to the details available on clinicaltrials.gov, this current research study is actively seeking eligible participants. It was initially posted on 11/21/2023 and most recently revised on 4/10/2024."

Answered by AI

What is the current number of individuals involved in this clinical trial as participants?

"Affirmative. The details on clinicaltrials.gov demonstrate that this research project is actively seeking individuals for participation. It was initially uploaded on November 21, 2023, and most recently revised on April 10, 2024. A total of 900 subjects are sought from a single designated location."

Answered by AI

Has the Food and Drug Administration endorsed the use of intravenous iron?

"Given the trial's Phase 3 status, with evidence supporting both effectiveness and safety from multiple iterations of data collection, Intravenous iron has been rated at a safety level of 3 by our team at Power."

Answered by AI