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

The Hospital for Sick Children

Status

Completed

Conditions

Iron Deficiency

Treatments

Other: Standard nutrition counselling

Other: Healthy milk intake

Study type

Interventional

Funder types

Other

Identifiers

NCT00907088

1000007781

Details and patient eligibility

About

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.

Full description

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.

Enrollment

251 patients

Sex

All

Ages

9 to 9 months old

Volunteers

Accepts Healthy Volunteers

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.