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RAPIDIRON Trial Follow-up Study: RAPIDIRON-KIDS Study

NCT05504863 · Status: ACTIVE_NOT_RECRUITING · Type: OBSERVATIONAL · Enrollment: 538

Last updated 2023-11-29

No results posted yet for this study

Summary

As a follow-up to the RAPIDIRON Trial (NCT05358509), this study will follow the previously randomized mothers as well as their offspring after birth to assess neurodevelopmental, hematologic, and health outcomes. The study's overarching goal is to determine if the offspring born to RAPIDIRON Trial mothers in the intravenous iron groups, compared to the oral iron group, will achieve superior neurodevelopment, iron stores, and growth at specific time points during the first three years of life. Differences will be assessed between offspring based on the iron deficiency anemia (IDA) treatment of the mother.

Conditions

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

  • S. Nijalingappa Medical College

    collaborator UNKNOWN

  • Raichur Institute of Medical Sciences

    collaborator UNKNOWN

  • 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
2022-10-11
Primary Completion
2025-01-31
Completion
2026-01-31

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 NCT05504863 on ClinicalTrials.gov