drugset / Trial / NCT01700426

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

NCT01700426

Phase 1 Completed 44 enrolled University of Colorado, Denver
RandomizedParallel-groupQuadruple-blindTreatment

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.

Timeline

Start
2011-06
Primary completion
2013-09
Completion
2013-09

Drugs

EvaluationDrugModalityDoseRoute
Comparator Vitamin E Other / unclassified 18 mg