<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT01700426</url>
  </required_header>
  <id_info>
    <org_study_id>10-1234</org_study_id>
    <nct_id>NCT01700426</nct_id>
  </id_info>
  <brief_title>Enhancing Treatment of Iron Deficiency and Iron Deficiency Anemia With an Antioxidant, Vitamin E</brief_title>
  <official_title>Enhancing Treatment of Iron Deficiency and Iron Deficiency Anemia With an Antioxidant, Vitamin E</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Colorado, Denver</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Colorado, Denver</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The study addresses treatment of iron deficiency, the most common nutritional deficiency that&#xD;
      infants and young children encounter. With the knowledge that iron deficiency may&#xD;
      irreversibly affect a baby's long-term neurodevelopment and behavior, the investigators are&#xD;
      offering free screening blood draws at Children's Hospital Colorado to older babies and&#xD;
      toddlers (9-24 months old). If their blood results indicate a serum ferritin of ≤ 15&#xD;
      micrograms/dL without the presence of an elevated C-reactive protein (CRP), they will be&#xD;
      invited to continue in the intervention portion of the study, where they will receive iron&#xD;
      supplements as well as vitamin E (or placebo) for an eight week treatment period. The&#xD;
      rationale for the study is to test whether addition of Vitamin E, an antioxidant and&#xD;
      anti-inflammatory agent, improves the treatment response to supplemental iron.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Enhancing Treatment of Iron Deficiency and Iron Deficiency Anemia with an Antioxidant,&#xD;
      Vitamin E&#xD;
&#xD;
      Synopsis/Abstract Iron Deficiency (ID) and Iron Deficiency Anemia (IDA) are common in older&#xD;
      breastfed infants and toddlers. Treatment of 3-6 mg iron/kg/day is recommended by the&#xD;
      American Academy of Pediatrics (AAP), but this regimen often results in only modest changes&#xD;
      in iron status, despite being a substantially higher dose (relative to body weight) than is&#xD;
      commonly used for adults. We propose that high therapeutic doses of iron induce an&#xD;
      inflammatory response, thus increasing hepatic synthesis of a critical regulator of iron&#xD;
      absorption, hepcidin, which functions to limit iron absorption in the context of&#xD;
      inflammation. In infants and toddlers found to have ID or IDA, we propose to evaluate the&#xD;
      efficacy of the addition of Vitamin E to iron therapy compared with the same dose of iron&#xD;
      alone. Our primary hypothesis is that in infants and toddlers with ID or IDA, 2 months of&#xD;
      supplemental Vitamin E combined with therapeutic iron supplementation will be more&#xD;
      efficacious than the same dose of iron alone. The study design is a randomized, double blind&#xD;
      efficacy trial of 2 months of iron therapy (6 mg/kg/day) with or without Vitamin E (18&#xD;
      mg/day), in infants and toddlers with ID or IDA from 9 to 24 months of age. Primary outcomes&#xD;
      include biomarkers of iron status (ferritin, hemoglobin, transferrin saturation, and&#xD;
      transferrin receptor); secondary outcomes include biomarkers of inflammation and oxidant&#xD;
      stress. Subjects: We will screen older infants (9-12 months of age) who were predominantly&#xD;
      breastfed through at least the first 9 months of life, and toddlers (12-24 months of age) who&#xD;
      were breastfed and/or who have modest dietary iron intakes. Intervention: Sixty-eight&#xD;
      subjects found to have ID or IDA will be consented and randomized to one of the two treatment&#xD;
      regimens (34 subjects per group). Liquid supplement preparations of iron (both groups),&#xD;
      Vitamin E (test) and placebo (control) will be distributed by the research pharmacy at The&#xD;
      Children's Hospital.Children's Hospital Colorado. Outcomes: Biomarkers of iron status, iron&#xD;
      homeostasis, oxidant stress, and of systemic and intestinal inflammation will be repeated at&#xD;
      the end of the intervention. If the hypotheses are supported, the findings would provide a&#xD;
      simple and effective modification to enhance iron therapy, and to improve the balance between&#xD;
      adequate iron uptake to meet physiologic needs and excessive iron intake and its potential&#xD;
      adverse effects.&#xD;
&#xD;
      I. Goals and objectives:&#xD;
&#xD;
      The broad goal of this proposal is to improve the health and nutrition of young children by&#xD;
      improving iron status of infants and toddlers who have developed iron deficiency (ID) or iron&#xD;
      deficiency anemia (IDA). The specific objective is to test an intervention proposed to&#xD;
      enhance the efficacy, and minimize potential toxicity, of therapeutic iron for infants and&#xD;
      young children who have a dietary iron deficiency.&#xD;
&#xD;
      Iron deficiency is the most common micronutrient deficiency in the world and negatively&#xD;
      impacts health in several ways 1, 2. ID and IDA contribute to stunting and impaired growth,&#xD;
      increased behavioral problems, and delayed mental and motor development 3, 4, 5-7. Studies&#xD;
      have also shown that some of the behavioral and developmental consequences of ID and IDA in&#xD;
      young children are not reversible with treatment 8. Despite the fortification of infant and&#xD;
      toddler foods in the United States, a significant number of children still develop ID or IDA&#xD;
      9. Current treatment recommendations include a wide dosage range (3-6 mg/kg/day), which&#xD;
      represents amounts that are higher than routine supplementation levels for adults (typically&#xD;
      equivalent to &lt; 1 mg/kg/day), reflecting the challenge and imprecision of effective treatment&#xD;
      for ID and IDA in children. Iron excess is not without risk, and studies in adults have shown&#xD;
      local (intestinal) and systemic inflammatory changes within days of iron therapy initiation&#xD;
      10, 11. Recent advances in the understanding of the regulation of iron homeostasis and&#xD;
      metabolism indicate that systemic inflammation induces a protein called hepcidin, which&#xD;
      blocks the uptake of iron into the body12, 13. Thus, stimulation of inflammation by high dose&#xD;
      iron supplements may actually counteract the intended beneficial effect of the increase in&#xD;
      iron intake.&#xD;
&#xD;
      Vitamin E is an essential nutrient that functions as an antioxidant and anti-inflammatory&#xD;
      agent, and has been studied for many potentially beneficial facets of human health, including&#xD;
      potential for protection against heart disease14; accelerated aging mediated through DNA&#xD;
      damage; and impaired immunity 15. Research in adults giving antioxidants along with iron&#xD;
      therapy was associated with reduced oxidative potential. In this study, a palm oil extract&#xD;
      containing approximately 7 mg of Vitamin E was supplemented along with iron therapy and was&#xD;
      associated with reduced fecal oxidation 16 Alpha-tocopherol is the most studied form of&#xD;
      Vitamin E, and has been shown to decrease biomarkers of total body oxidative stress and&#xD;
      inflammation 15, 17. We propose to accomplish our primary specific objective by testing the&#xD;
      effect on treatment outcomes of administration of Vitamin E along with iron supplements.&#xD;
&#xD;
      II. Hypotheses:&#xD;
&#xD;
      Our central hypothesis is that in infants and toddlers with ID or IDA, 2 months of&#xD;
      supplemental Vitamin E combined with therapeutic iron supplementation at 6 mg/kg/day will be&#xD;
      more efficacious than the same dose of iron alone. The specific hypotheses to be tested by&#xD;
      the intervention are:&#xD;
&#xD;
      Hypothesis 1: Subjects receiving both iron and vitamin E supplements will have significantly&#xD;
      greater changes in serum ferritin (reflecting greater improvement in their iron status), than&#xD;
      subjects receiving iron alone after eight weeks of supplementation.&#xD;
&#xD;
      Hypothesis 2: Significantly more subjects receiving both iron and vitamin E supplements will&#xD;
      have an improved iron status profile, including ferritin, transferrin saturation, and serum&#xD;
      transferrin receptor, than subjects receiving iron alone.&#xD;
&#xD;
      Hypothesis 3 Subjects receiving both iron and vitamin E supplements will have significantly&#xD;
      lower levels of inflammatory and oxidant stress biomarkers than subjects receiving iron&#xD;
      alone.&#xD;
&#xD;
      Hypothesis 4: (exploratory): The exposure to two months of iron therapy will be associated&#xD;
      with significantly altered intestinal bacterial profiles compared to baseline, and at the end&#xD;
      of therapy, the placebo group will have a greater predominance of potentially pathogenic&#xD;
      bacterial phyla.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>June 2011</start_date>
  <completion_date type="Actual">September 2013</completion_date>
  <primary_completion_date type="Actual">September 2013</primary_completion_date>
  <phase>Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Evaluation of iron status, as represented by serum ferritin, to be compared between groups</measure>
    <time_frame>Up to 8 weeks</time_frame>
    <description>The primary outcome evaluated in this study is iron status, as represented by serum ferritin. Biomarkers include ferritin, hemoglobin, transferrin saturation, and transferrin receptor</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Biomarkers of inflammation</measure>
    <time_frame>Up to 8 weeks</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Biomarkers of oxidant stress</measure>
    <time_frame>Up to 8 weeks</time_frame>
    <description>Secondary outcome include biomarkers oxidant stress. We propose to measure urine F2-isoprostanes as a measure of systemic oxidant stress</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">44</enrollment>
  <condition>Iron Deficiency</condition>
  <condition>Iron Deficiency Anemia</condition>
  <arm_group>
    <arm_group_label>iron</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>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.&#xD;
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.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>iron 2</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>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.&#xD;
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.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Vitamin E</intervention_name>
    <description>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.</description>
    <arm_group_label>iron</arm_group_label>
    <other_name>Aqueous Vitamin E®, 15 IU/0.3 ml</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>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.</description>
    <arm_group_label>iron 2</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Between 9-24 months of age&#xD;
&#xD;
          -  Weighed 5.5 lbs or more at birth&#xD;
&#xD;
          -  Born at 34 week gestation or more&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Consumed infant formula within the past 3 months&#xD;
&#xD;
          -  Inflammatory bowel disease, cystic fibrosis, liver or kidney disease, cancer, HIV,&#xD;
             primary immune deficiencies, anemia unrelated to iron status, chronic blood loss in&#xD;
             stool, inherited disorders or iron status, or bleeding or coagulation disorders)&#xD;
&#xD;
          -  Previous diagnosis of iron deficiency or iron deficiency anemia&#xD;
&#xD;
          -  Previous treatment of iron deficiency or iron deficiency anemia&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>9 Months</minimum_age>
    <maximum_age>2 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Nancy F Krebs, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Colorado, Denver</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Colorado Denver</name>
      <address>
        <city>Aurora</city>
        <state>Colorado</state>
        <zip>80045</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>March 2014</verification_date>
  <study_first_submitted>September 21, 2012</study_first_submitted>
  <study_first_submitted_qc>October 1, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 4, 2012</study_first_posted>
  <last_update_submitted>March 25, 2014</last_update_submitted>
  <last_update_submitted_qc>March 25, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">March 27, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Iron Deficiency</keyword>
  <keyword>Iron Deficiency Anemia</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Anemia</mesh_term>
    <mesh_term>Anemia, Iron-Deficiency</mesh_term>
    <mesh_term>Iron Deficiencies</mesh_term>
    <mesh_term>Deficiency Diseases</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Vitamins</mesh_term>
    <mesh_term>Vitamin E</mesh_term>
    <mesh_term>Tocopherols</mesh_term>
    <mesh_term>Tocotrienols</mesh_term>
    <mesh_term>alpha-Tocopherol</mesh_term>
  </intervention_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT01700426
org study id: 10-1234
nct id: NCT01700426
lead sponsor: 
has dmc: No
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.
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 group). Liquid supplement preparations of iron (both groups),
      Vitamin E (test) and placebo (control) will be distributed by the research pharmacy at The
      Children's Hospital.Children's Hospital Colorado. Outcomes: Biomarkers of iron status, iron
      homeostasis, oxidant stress, and of systemic and intestinal inflammation will be repeated at
      the end of the intervention. If the hypotheses are supported, the findings would provide a
      simple and effective modification to enhance iron therapy, and to improve the balance between
      adequate iron uptake to meet physiologic needs and excessive iron intake and its potential
      adverse effects.

      I. Goals and objectives:

      The broad goal of this proposal is to improve the health and nutrition of young children by
      improving iron status of infants and toddlers who have developed iron deficiency (ID) or iron
      deficiency anemia (IDA). The specific objective is to test an intervention proposed to
      enhance the efficacy, and minimize potential toxicity, of therapeutic iron for infants and
      young children who have a dietary iron deficiency.

      Iron deficiency is the most common micronutrient deficiency in the world and negatively
      impacts health in several ways 1, 2. ID and IDA contribute to stunting and impaired growth,
      increased behavioral problems, and delayed mental and motor development 3, 4, 5-7. Studies
      have also shown that some of the behavioral and developmental consequences of ID and IDA in
      young children are not reversible with treatment 8. Despite the fortification of infant and
      toddler foods in the United States, a significant number of children still develop ID or IDA
      9. Current treatment recommendations include a wide dosage range (3-6 mg/kg/day), which
      represents amounts that are higher than routine supplementation levels for adults (typically
      equivalent to < 1 mg/kg/day), reflecting the challenge and imprecision of effective treatment
      for ID and IDA in children. Iron excess is not without risk, and studies in adults have shown
      local (intestinal) and systemic inflammatory changes within days of iron therapy initiation
      10, 11. Recent advances in the understanding of the regulation of iron homeostasis and
      metabolism indicate that systemic inflammation induces a protein called hepcidin, which
      blocks the uptake of iron into the body12, 13. Thus, stimulation of inflammation by high dose
      iron supplements may actually counteract the intended beneficial effect of the increase in
      iron intake.

      Vitamin E is an essential nutrient that functions as an antioxidant and anti-inflammatory
      agent, and has been studied for many potentially beneficial facets of human health, including
      potential for protection against heart disease14; accelerated aging mediated through DNA
      damage; and impaired immunity 15. Research in adults giving antioxidants along with iron
      therapy was associated with reduced oxidative potential. In this study, a palm oil extract
      containing approximately 7 mg of Vitamin E was supplemented along with iron therapy and was
      associated with reduced fecal oxidation 16 Alpha-tocopherol is the most studied form of
      Vitamin E, and has been shown to decrease biomarkers of total body oxidative stress and
      inflammation 15, 17. We propose to accomplish our primary specific objective by testing the
      effect on treatment outcomes of administration of Vitamin E along with iron supplements.

      II. Hypotheses:

      Our central hypothesis is that in infants and toddlers with ID or IDA, 2 months of
      supplemental Vitamin E combined with therapeutic iron supplementation at 6 mg/kg/day will be
      more efficacious than the same dose of iron alone. The specific hypotheses to be tested by
      the intervention are:

      Hypothesis 1: Subjects receiving both iron and vitamin E supplements will have significantly
      greater changes in serum ferritin (reflecting greater improvement in their iron status), than
      subjects receiving iron alone after eight weeks of supplementation.

      Hypothesis 2: Significantly more subjects receiving both iron and vitamin E supplements will
      have an improved iron status profile, including ferritin, transferrin saturation, and serum
      transferrin receptor, than subjects receiving iron alone.

      Hypothesis 3 Subjects receiving both iron and vitamin E supplements will have significantly
      lower levels of inflammatory and oxidant stress biomarkers than subjects receiving iron
      alone.

      Hypothesis 4: (exploratory): The exposure to two months of iron therapy will be associated
      with significantly altered intestinal bacterial profiles compared to baseline, and at the end
      of therapy, the placebo group will have a greater predominance of potentially pathogenic
      bacterial phyla.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Evaluation of iron status, as represented by serum ferritin, to be compared between groups
time frame: Up to 8 weeks
description: The primary outcome evaluated in this study is iron status, as represented by serum ferritin. Biomarkers include ferritin, hemoglobin, transferrin saturation, and transferrin receptor
measure: Biomarkers of inflammation
time frame: Up to 8 weeks
description: 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.
measure: Biomarkers of oxidant stress
time frame: Up to 8 weeks
description: Secondary outcome include biomarkers oxidant stress. We propose to measure urine F2-isoprostanes as a measure of systemic oxidant stress
arm group label: iron
arm group type: Active Comparator
description: 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.
arm group label: iron 2
arm group type: Active Comparator
description: 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.
intervention type: Drug
intervention name: Vitamin E
description: 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.
arm group label: iron
other name: Aqueous Vitamin E®, 15 IU/0.3 ml
intervention type: Other
intervention name: Placebo
description: 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.
arm group label: iron 2
criteria: 
gender: All
minimum age: 9 Months
maximum age: 2 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Nancy F Krebs, MD
role: Principal Investigator
affiliation: University of Colorado, Denver
facility: 
country: United States
responsible party type: Sponsor
mesh term: Anemia
mesh term: Anemia, Iron-Deficiency
mesh term: Iron Deficiencies
mesh term: Deficiency Diseases
mesh term: Vitamins
mesh term: Vitamin E
mesh term: Tocopherols
mesh term: Tocotrienols
mesh term: alpha-Tocopherol