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

NCT01700426 | Completed Phase 1

• 1 other identifier: 10-1234
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

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.

Conditions

Iron Deficiency; Iron Deficiency Anemia

Keywords

Iron Deficiency; Iron Deficiency Anemia

Outcome Measures

Primary Outcomes (1)

• Evaluation of iron status, as represented by serum ferritin, to be compared between groups

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

  Up to 8 weeks

Secondary Outcomes (2)

• Biomarkers of inflammation

  Up to 8 weeks

• Biomarkers of oxidant stress

  Up to 8 weeks

Study Arms (2)

iron

ACTIVE COMPARATOR

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

iron 2

ACTIVE COMPARATOR

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

Interventions

Vitamin E DRUG

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 Children's Hospital Colorado (CHC) research pharmacist. The Vitamin E dose will be 18 mg/day for all subjects randomized to the Vitamin E group.

Also known as: Aqueous Vitamin E®, 15 IU/0.3 ml

iron

Placebo OTHER

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.

iron 2

Eligibility Criteria

• Age: 9 Months - 2 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Between 9-24 months of age
• Weighed 5.5 lbs or more at birth
• Born at 34 week gestation or more

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Colorado, Denver: lead

Study Sites (1)

University of Colorado Denver

Aurora, Colorado, 80045, United States

Location

Related Publications (1)

• Tang M, Frank DN, Sherlock L, Ir D, Robertson CE, Krebs NF. Effect of Vitamin E With Therapeutic Iron Supplementation on Iron Repletion and Gut Microbiome in US Iron Deficient Infants and Toddlers. J Pediatr Gastroenterol Nutr. 2016 Sep;63(3):379-85. doi: 10.1097/MPG.0000000000001154.

  PMID: 27548249 DERIVED

MeSH Terms

Conditions

Iron Deficiencies; Anemia, Iron-Deficiency

Interventions

Vitamin E

Condition Hierarchy (Ancestors)

Iron Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Anemia, Hypochromic; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Benzopyrans; Pyrans; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Nancy F Krebs, MD

  University of Colorado, Denver

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 21, 2012
• First Posted: October 4, 2012
• Study Start: June 1, 2011
• Primary Completion: September 1, 2013
• Study Completion: September 1, 2013
• Last Updated: March 27, 2014

Record last verified: 2014-03

Locations

US (1)