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

• Status: Completed
• Trial end date: 2013-09-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University of Colorado, Denver
• Treatments: alpha-Tocopherol; Antioxidants; Iron; Tocopherols; Tocotrienols; Vitamin E; Vitamins

Criteria

Inclusion Criteria:

• Between 9-24 months of age

• Weighed 5.5 lbs or more at birth

• Born at 34 week gestation or more

Exclusion Criteria:

• Consumed infant formula within the past 3 months

• Inflammatory bowel disease, cystic fibrosis, liver or kidney disease, cancer, HIV, primary immune deficiencies, anemia unrelated to iron status, chronic blood loss in stool, inherited disorders or iron status, or bleeding or coagulation disorders)

• Previous diagnosis of iron deficiency or iron deficiency anemia

• Previous treatment of iron deficiency or iron deficiency anemia