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NCT01700426 · ClinicalTrials.gov registry record · Phase 1

Enhancing Treatment of Iron Deficiency and Iron Deficiency Anemia With an Antioxidant, Vitamin E

A Phase 1 study, sponsored by University of Colorado, Denver.

Completed
Registry status
Phase 1
Development phase
44
Enrollment target

NCT01700426: Completed Phase 1 study, sponsored by University of Colorado, Denver.

NCT01700426 is a Phase 1 study that has completed, run by University of Colorado, Denver. The registered enrollment target is 44 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (27% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01700426, a Phase 1 study, has completed, sponsored by University of Colorado, Denver.

COMPLETED
Registry status
Phase 1
Development phase
44 participants
Enrollment target

Study Summary

The study addresses treatment of iron deficiency, the most common nutritional deficiency that infants and young children encounter. With the knowledge that iron deficiency may irreversibly affect a baby's long-term neurodevelopment and behavior, the investigators are offering free screening blood draws at Children's Hospital Colorado to older babies and toddlers (9-24 months old). If their blood results indicate a serum ferritin of ≤ 15 micrograms/dL without the presence of an elevated C-reactive protein (CRP), they will be invited to continue in the intervention portion of the study, where they will receive iron supplements as well as vitamin E (or placebo) for an eight week treatment period. The rationale for the study is to test whether addition of Vitamin E, an antioxidant and anti-inflammatory agent, improves the treatment response to supplemental iron.

Primary Outcome

The primary outcome evaluated in this study is iron status, as represented by serum ferritin. Biomarkers include ferritin, hemoglobin, transferrin saturation, and transferrin receptor

Interventions

  • OTHER Placebo
  • DRUG Vitamin E

Trial Details

FieldValue
Enrollment Target 44 participants
Start Date 2011-06
Est. Completion 2013-09
Phase Phase 1
University of Colorado, Denver

1,283 total trials

What the finished NCT01700426 record still lists

NCT01700426 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 44 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (27% lower).

The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.

NCT01700426 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01700426 about?

NCT01700426 is a clinical study titled "Enhancing Treatment of Iron Deficiency and Iron Deficiency Anemia With an Antioxidant, Vitamin E". The study addresses treatment of iron deficiency, the most common nutritional deficiency that infants and young children encounter. With the knowledge that iron deficiency may irreversibly affect a baby's long-term neurodevelopment and behavior, the investigators are offering free screening blood dr...

What is the current status of trial NCT01700426?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 44 participants. The study started on 2011-06. Estimated completion is 2013-09.

What interventions are being tested in trial NCT01700426?

The interventions under investigation include: Placebo (OTHER), Vitamin E (DRUG).

Who is sponsoring clinical trial NCT01700426?

This trial is sponsored by University of Colorado, Denver, which has 1,283 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT01700426's enrollment target sits among peer trials

44 1086th of 2000 higher than 901 of 2,000 other Phase 1 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 1 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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Source: ClinicalTrials.gov NCT01700426, the US trial registry maintained by the National Library of Medicine. NCT01700426 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.