Multicenter Randomized Active-controlled Study to Investigate Efficacy & Safety of IV FCM in Pediatric Patients With IDA
Public ClinicalTrials.gov record NCT03523117. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Multicenter, Randomized, Active-Controlled Study to Investigate the Efficacy and Safety of Intravenous Ferric Carboxymaltose in Pediatric Patients With Iron Deficiency Anemia
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The primary objective of this study is to demonstrate the efficacy and safety of intravenous ferric carboxymaltose (FCM), compared to oral iron, in pediatric participants who have iron deficiency anemia.
Study identification
- NCT ID
- NCT03523117
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 79 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 1 Year to 17 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jan 30, 2019
- Primary completion
- Dec 21, 2020
- Completion
- Jan 28, 2021
- Last update posted
- Jun 21, 2022
2019 – 2021
United States locations
- U.S. sites
- 16
- U.S. states
- 9
- U.S. cities
- 13
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Arkansas Children's Hospital | Little Rock | Arkansas | 72202 | — |
| International Research Partners, Inc. | Doral | Florida | 33122 | — |
| ProHealth Research Center | Doral | Florida | 33166 | — |
| Garden Medical Research, Inc. | Miami | Florida | 33155 | — |
| Miami Clinical Research | Miami | Florida | 33155 | — |
| South Florida Research Phase I-IV | Miami Springs | Florida | 33166 | — |
| Riley Hospital for Children,Room 4340 | Indianapolis | Indiana | 46202 | — |
| Caro Health Plaza | Caro | Michigan | 48723 | — |
| Galen Research | Chesterfield | Missouri | 63005 | — |
| Tiga Pediatrics, PC | The Bronx | New York | 10467 | — |
| Cincinnati Children's Hospital and Medical Center | Cincinnati | Ohio | 45229 | — |
| Cincinnati Children's Hospital Medical Center | Cincinnati | Ohio | 45229 | — |
| Cook Children's Medical Center | Fort Worth | Texas | 76101 | — |
| Baylor College of Medicine/Texas Children Hospital | Houston | Texas | 77030 | — |
| Tekton Research | San Antonio | Texas | 78240 | — |
| Aspen Clinical Research | Orem | Utah | 84058 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT03523117, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jun 21, 2022 · Synced Sep 2, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete protocol, eligibility criteria, and contact information for NCT03523117 live on ClinicalTrials.gov.