Nutritional Education and the Prevention of Iron Depletion in Children 9 Months to 2 Years

Study Overview
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Brief Summary
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Iron depletion in young children is common and may progress to iron deficiency anemia which is associated with irreversible neurodevelopmental effects. Efforts to prevent iron depletion are key to preventing these effects. In a recent study of 150 young children (12 to 38 months), we found that bottle fed children were almost three times as likely to be iron depleted compared with cup fed children (37% vs 18%). Thus, we hypothesize that an educational intervention designed to encourage timely bottle weaning will lead to a reduction in iron depletion.

Detailed Description
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We plan to undertake a randomized controlled trial to evaluate the effectiveness of an office-based educational intervention for the prevention of iron depletion in young children. Healthy children will be recruited from a community pediatric office which serves a diverse, urban population. Children will be randomized to the intervention education group or the control education group at 9 months of age. Blood work ( 4mL) for complete blood count and ferritin along with additional measures such as transferrin, iron, and reticulocyte count will be obtained at 24 months of age. Rates of iron depletion and anemia will be compared in the two groups. The two groups will also have 25-hydroxy vitamin D, calcium and alkaline phosphatase levels analyzed at the 24 month visit to ensure that the intervention for prevention of iron depletion does not adversely affect these measures.

Official Title
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Nutritional Education and the Prevention of Iron Depletion in Children 9 Months to 2 Years: a Randomized Controlled Trial

Conditions
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Iron Deficiency

Intervention / Treatment
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* Other: Healthy milk intake
* Other: Standard nutrition counselling


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Children aged 9 months who are attending a routine primary care well-child visit. Children who are in good general health. Children whose parents provide informed consent to participate. Exclusion Criteria: Children with chronic illness. Children with birth weight less than 2.5 kg. Children with previously diagnosed anemia (including known iron deficiency anemia). This includes children with marrow failure (aplastic anemia, Fanconi anemia), hemoglobinopathies (sickle cell disease, thalassemia), lead intoxication, sideroblastic anemia, megaloblastic anemia, enzymopathies (G6PD deficiency, pyruvate kinase deficiency), or membranopathies (hereditary spherocytosis). Children currently receiving medications associated with anemia. This includes children taking antimetabolites or phenytoin. Children currently receiving iron supplementation other than iron fortified formula.

Ages Eligible for Study
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Minimum Age: 9 Months
Maximum Age: 9 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br> | Other: Standard nutrition counselling<br>* Parents of children will receive nutrition counselling via trained study personnel, including recommendations for iron containing food choices and timing of cow's milk introduction. This group will also receive a colourful nutrition book.<br>|
| Experimental: 2<br> | Other: Healthy milk intake<br>* In addition to the standard nutrition counselling, the intervention group will receive specific information regarding healthy milk intake (2 cups per day, maximum 16 ounces) and the potential negative health effects of prolonged bottle use and excessive milk intake including anemia, iron depletion, and dental carries.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Primary Outcome is Iron Depletion, and Will be Defined as Serum Ferritin <10 mcg/L. |  | Age 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Iron Deficiency (Defined as Serum Ferritin <10 mcg/L and MCV < 70 mcm3 Iron Deficiency. |  | Age 24 months | 
| IDA (Hemoglobin < 110 g/L With Iron Deficiency) |  | Age 24 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Iron depletion, Children, Educational intervention, Office-based