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

This study is currently recruiting participants.
Verified October 2012 by University of Colorado, Denver
Sponsor:
Information provided by (Responsible Party):
University of Colorado, Denver
ClinicalTrials.gov Identifier:
NCT01700426
First received: September 21, 2012
Last updated: October 3, 2012
Last verified: October 2012
History of Changes
  Purpose

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.


Condition Intervention Phase
Iron Deficiency
Iron Deficiency Anemia
 Drug: Vitamin E
Other: Placebo
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Enhancing Treatment of Iron Deficiency and Iron Deficiency Anemia With an Antioxidant, Vitamin E

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Colorado, Denver:

Primary Outcome Measures:
  • Evaluation of iron status, as represented by serum ferritin, to be compared between groups [ Time Frame: Up to 8 weeks ] [ Designated as safety issue: Yes ]
    The primary outcome evaluated in this study is iron status, as represented by serum ferritin. Biomarkers include ferritin, hemoglobin, transferrin saturation, and transferrin receptor


Secondary Outcome Measures:
  • Biomarkers of inflammation [ Time Frame: Up to 8 weeks ] [ Designated as safety issue: No ]
    Secondary outcomes include biomarkers of intestinal and systemic inflammation and of systemic oxidative stress. We will use serum IL-4, CRP, and 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 ] [ Designated as safety issue: No ]
    Secondary outcome include biomarkers oxidant stress. We propose to measure urine F2-isoprostanes as a measure of systemic oxidant stress


Estimated Enrollment: 68
Study Start Date: June 2011
Estimated Study Completion Date: April 2013
Estimated Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: iron

Sixty-eight subjects found to have ID or IDA will be consented and randomized to one of the two treatment regimens (34 subjects per group). Liquid supplement preparations of iron (both groups), Vitamin E (test) and placebo (control) will be distributed by the research pharmacy at Children's Hospital Colorado.

A commercial ferrous sulfate solution (Fer-In-Sol, 15 mg elemental Fe/mL; Mead Johnson, Inc, Evansville, IN) will be distributed to all qualifying participants for the study by the research pharmacy at Children's Hospital Colorado. The volume of the suspension will be individualized by the pharmacy to the infant's weight, to maintain consistent iron dosing at 6 mg/kg/day.

 Drug: Vitamin E
A commercial Vitamin E preparation (Aqueous Vitamin E®, 15 IU/0.3 ml; SilaRx, Inc, Spring Valley, NY) will be used for the study, also on the recommendation of the CHC research pharmacist. The Vitamin E dose will be 18 mg/day for all subjects randomized to the Vitamin E group.
Other Name: Aqueous Vitamin E®, 15 IU/0.3 ml
Active Comparator: iron 2

Sixty-eight subjects found to have ID or IDA will be consented and randomized to one of the two treatment regimens (34 subjects per group). Liquid supplement preparations of iron (both groups), Vitamin E (test) and placebo (control) will be distributed by the research pharmacy at Children's Hospital Colorado.

A commercial ferrous sulfate solution (Fer-In-Sol, 15 mg elemental Fe/mL; Mead Johnson, Inc, Evansville, IN) will be distributed to all qualifying participants for the study by the research pharmacy at Children's Hospital Colorado. The volume of the suspension will be individualized by the pharmacy to the infant's weight, to maintain consistent iron dosing at 6 mg/kg/day.

 Other: Placebo
The control group will receive an indistinguishable placebo preparation, which will be compounded by the CHC research pharmacy using the following inactive ingredients: purified water, polysorbate 80, sorbital, and propylene glycol. This suspension is stable for 6 months.
Other Name: placebo

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  Eligibility

Ages Eligible for Study:   9 Months to 2 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01700426

Contacts
Contact: Sarah E Baumbach, BA 303-724-3248 sarah.baumbach@ucdenver.edu
Contact: Jamie Westcott, MS 303-724-3265 jamie.westcott@ucdenver.edu

Locations
United States, Colorado
University of Colorado Denver Recruiting
Aurora, Colorado, United States, 80045
Contact: Sarah E Baumbach, BA     303-724-3248     sarah.baumbach@ucdenver.edu    
Contact: Jamie Westcott, MS     303-724-3265     Jamie.Westcott@ucdenver.edu    
Principal Investigator: Nancy F Krebs, MD            
Sponsors and Collaborators
University of Colorado, Denver
Investigators
Principal Investigator: Nancy F Krebs, MD University of Colorado, Denver
  More Information

No publications provided

Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT01700426     History of Changes
Other Study ID Numbers: 10-1234
Study First Received: September 21, 2012
Last Updated: October 3, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by University of Colorado, Denver:
Iron Deficiency
Iron Deficiency Anemia

Additional relevant MeSH terms:
Anemia
Deficiency Diseases
Anemia, Iron-Deficiency
Hematologic Diseases
Malnutrition
Nutrition Disorders
Anemia, Hypochromic
Iron Metabolism Disorders
Metabolic Diseases
Antioxidants
Vitamin E
Alpha-Tocopherol
 Tocopherols
Tocotrienols
Vitamins
Iron
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Protective Agents
Physiological Effects of Drugs
Micronutrients
Growth Substances
Trace Elements

ClinicalTrials.gov processed this record on May 23, 2013