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Neuroimaging Ancillary Study

NCT05545527 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 184

Last updated 2025-04-16

No results posted yet for this study

Summary

As a follow-up to the RAPIDIRON Trial (NCT05358509), and in combination with the RAPIDIRON-KIDS Study (NCT05504863), this study will involve infants of RAPIDIRON Trial participants recruited at one site in Karnataka and is designed to implement a magnetic resonance imaging (MRI) protocol and incorporate neuroimaging measures. Implementation of this study will promote an understanding of the effects on fetal and neonatal brain development, including iron deposition in brain tissues, when a woman is treated for iron deficiency anemia (IDA) by either (a) providing her oral iron tablets and instructions for use; or (b) administering a single-dose IV iron infusion for the treatment of IDA during pregnancy.

Conditions

  • Iron Deficiency Anemia
  • Iron Deficiency Anemia of Pregnancy
  • Neurodevelopmental Disorder of Foetus
  • Iron Deficiency Anemia Treatment
  • Fetal Neurodevelopmental Disorder
  • Child Development

Interventions

DRUG

Ferric carboxymaltose

As part of the RAPIDIRON Trial, maternal participants randomized to intervention arm 1 were given a single dose of ferric carboxymaltose between 14 and 17 weeks of pregnancy.

DRUG

Iron isomaltoside

As part of the RAPIDIRON Trial, maternal participants randomized to intervention arm 2 were given a single dose of iron isomaltoside between 14 and 17 weeks of pregnancy.

DRUG

Ferric Sulfate

As part of the RAPIDIRON Trial, maternal participants randomized to the active comparator arm were given 200 ferrous sulfate tablets immediately after randomization (\~12 weeks of pregnancy). Participants were instructed to take two tablets a day, with each tablet containing 60mg elemental iron.

Sponsors & Collaborators

  • Jawaharlal Nehru Medical College

    collaborator OTHER

  • Thomas Jefferson University

    lead OTHER

Principal Investigators

  • Richard Derman, MD, MPH · Thomas Jefferson University

Eligibility

Min Age
18 Years
Max Age
40 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-02-21
Primary Completion
2024-02-14
Completion
2025-04-07

Countries

  • India

Study Locations

More Related Trials

Entities

Diseases

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 NCT05545527 on ClinicalTrials.gov