Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT01904864 · ClinicalTrials.gov registry record · Phase 4
Comparison of NovaFerrum® vs Ferrous Sulfate Treatment in Young Children With Nutritional Iron Deficiency Anemia
A Phase 4 study, sponsored by University of Texas Southwestern Medical Center.
- Completed
- Registry status
- Phase 4
- Development phase
- 80
- Enrollment target
NCT01904864 is a Phase 4 study that has completed, run by University of Texas Southwestern Medical Center. The registered enrollment target is 80 participants.
The verdict
NCT01904864, a Phase 4 study, has completed, sponsored by University of Texas Southwestern Medical Center.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 80 participants
- Enrollment target
Study Summary
This study is a randomized, controlled, double-blinded single center trial to compare the efficacy of NovaFerrum® to ferrous sulfate for the treatment of nutritional iron deficiency anemia (IDA) in infants and young children. Hypothesis: NovaFerrum® has greater efficacy than ferrous sulfate in increasing hemoglobin concentration during a twelve week course of treatment to subjects with iron deficiency anemia. Primary Aim: To compare the efficacy of NovaFerrum® to ferrous sulfate for the treatment of nutritional IDA in infants and young children as determined by increase in hemoglobin concentration. Secondary Aims: 1. To compare the adverse effects of treatment for IDA between ferrous sulfate and NovaFerrum® 2. To compare normalization of iron stores as demonstrated by laboratory measures of IDA (ferritin, TIBC, reticulocyte hemoglobin content) between subjects treated with ferrous sulfate or NovaFerrum® 3. To compare the adherence to study medication between subjects on ferrous sulfate and NovaFerrum® 4. To demonstrate efficacy of a once daily dosing regimen in the treatment of nutritional IDA
Interventions
- DRUG elemental iron (NovaFerrum®)
- DRUG elemental iron (Ferrous Sulfate)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 80 participants |
| Start Date | 2013-07 |
| Est. Completion | 2015-11 |
| Phase | Phase 4 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01904864
The ClinicalTrials.gov registry entry for NCT01904864 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 80 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Texas Southwestern Medical Center, which has 837 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which elemental iron (NovaFerrum®) is the first listed.
NCT01904864 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01904864 about?
NCT01904864 is a clinical study titled "Comparison of NovaFerrum® vs Ferrous Sulfate Treatment in Young Children With Nutritional Iron Deficiency Anemia". This study is a randomized, controlled, double-blinded single center trial to compare the efficacy of NovaFerrum® to ferrous sulfate for the treatment of nutritional iron deficiency anemia (IDA) in infants and young children. Hypothesis: NovaFerrum® has greater efficacy than ferrous sulfate in incr...
What is the current status of trial NCT01904864?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 80 participants. The study started on 2013-07. Estimated completion is 2015-11.
What interventions are being tested in trial NCT01904864?
The interventions under investigation include: elemental iron (NovaFerrum®) (DRUG), elemental iron (Ferrous Sulfate) (DRUG).
Who is sponsoring clinical trial NCT01904864?
This trial is sponsored by University of Texas Southwestern Medical Center, which has 837 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.