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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

Brief 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.

Detailed Summary:

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

Synopsis/Abstract Iron Deficiency (ID) and Iron Deficiency Anemia (IDA) are common in older breastfed infants and toddlers. Treatment of 3-6 mg iron/kg/day is recommended by the American Academy of Pediatrics (AAP), but this regimen often results in only modest changes in iron status, despite being a substantially higher dose (relative to body weight) than is commonly used for adults. We propose that high therapeutic doses of iron induce an inflammatory response, thus increasing hepatic synthesis of a critical regulator of iron absorption, hepcidin, which functions to limit iron absorption in the context of inflammation. In infants and toddlers found to have ID or IDA, we propose to evaluate the efficacy of the addition of Vitamin E to iron therapy compared with the same dose of iron alone. Our primary hypothesis is that in infants and toddlers with ID or IDA, 2 months of supplemental Vitamin E combined with therapeutic iron supplementation will be more efficacious than the same dose of iron alone. The study design is a randomized, double blind efficacy trial of 2 months of iron therapy (6 mg/kg/day) with or without Vitamin E (18 mg/day), in infants and toddlers with ID or IDA from 9 to 24 months of age. Primary outcomes include biomarkers of iron status (ferritin, hemoglobin, transferrin saturation, and transferrin receptor); secondary outcomes include biomarkers of inflammation and oxidant stress. Subjects: We will screen older infants (9-12 months of age) who were predominantly breastfed through at least the first 9 months of life, and toddlers (12-24 months of age) who were breastfed and/or who have modest dietary iron intakes. Intervention: Sixty-eight subjects found to have ID or IDA will be consented and randomized to one of the two treatment regimens (34 subjects per g
Sponsor: University of Colorado, Denver

Current Primary Outcome: Evaluation of iron status, as represented by serum ferritin, to be compared between groups [ Time Frame: Up to 8 weeks ]

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


Original Primary Outcome: Evaluation of iron status, as represented by serum ferritin, to be compared between groups [ Time Frame: Up to 8 weeks ]

The primary outcome evaluated in this study is iron status, as represented by serum ferritin


Current Secondary Outcome:

  • Biomarkers of inflammation [ Time Frame: Up to 8 weeks ]
    Secondary outcomes include biomarkers of intestinal and systemic inflammation and of systemic oxidative stress. We will use serum Interleukin (IL)-4, C-Reactive Protein (CRP), and Tumor necrosis factor (TNF)-alpha as indicators of systemic inflammation; and fecal calprotectin as a marker of intestinal (local) inflammation.
  • Biomarkers of oxidant stress [ Time Frame: Up to 8 weeks ]
    Secondary outcome include biomarkers oxidant stress. We propose to measure urine F2-isoprostanes as a measure of systemic oxidant stress


Original Secondary Outcome:

  • Biomarkers of inflammation [ Time Frame: Up to 8 weeks ]
    Secondary outcomes include biomarkers of inflammation
  • Biomarkers of oxidant stress [ Time Frame: Up to 8 weeks ]
    Secondary outcome include biomarkers oxidant stress.


Information By: University of Colorado, Denver

Dates:
Date Received: September 21, 2012
Date Started: June 2011
Date Completion:
Last Updated: March 25, 2014
Last Verified: March 2014