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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: Completed Phase 4 study, sponsored by University of Texas Southwestern Medical Center.
NCT01904864 is a Phase 4 study that has completed, run by University of Texas Southwestern Medical Center. The registered enrollment target is 80 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (85% lower). According to ClinicalTrials.gov, the official US trial registry.
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
Primary Outcome
The primary outcome will be the change in the peripheral blood hemoglobin concentration in grams/deciliter upon serial measurements at 0, 4, 8, and 12 weeks post-initiation of treatment. The primary analysis consists of a linear mixed regression model, which incorporates all subsequent time points into the model and includes treatment and time as covariates and patient random effects to account for correlation among longitudinal measurements from the same patients.
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 |
What the finished NCT01904864 record still lists
NCT01904864 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 80 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (85% lower).
The record links to 0 conditions, and to 2 interventions - of which elemental iron (NovaFerrum®) is the first listed.
NCT01904864 does not publish any study locations in the registry export this page uses.
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
How this trial's enrollment target compares
Where NCT01904864's enrollment target sits among peer trials
80 946th of 2000 higher than 1,021 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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