Clinical trial NCT00907088: Nutritional Education and the Prevention of Iron Depletion in Children 9 Months to 2 Years
Official title: Nutritional Education and the Prevention of Iron Depletion in Children 9 Months to 2 Years: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Iron Deficiency
Keywords: Iron depletion
Children
Educational intervention
Office-based
Lead sponsor: The Hospital for Sick Children
Sponsor class: OTHER
First posted: 2009-05-22
Enrollment: 251
Sex: ALL
Minimum age (years): 9
Maximum age (years): 9
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: The Primary Outcome is Iron Depletion, and Will be Defined as Serum Ferritin <10 mcg/L.
timeFrame: Age 24 months
Secondary outcomes:
measure: Iron Deficiency (Defined as Serum Ferritin <10 mcg/L and MCV < 70 mcm3 Iron Deficiency.
timeFrame: Age 24 months
measure: IDA (Hemoglobin < 110 g/L With Iron Deficiency)
timeFrame: Age 24 months
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: The Hospital for Sick Children
state: Ontario
Study officials:
affiliation: The Hospital for Sick Children
name: Patricia Parkin, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Maguire JL, Birken CS, Jacobson S, Peer M, Taylor C, Khambalia A, Mekky M, Thorpe KE, Parkin P. Office-based intervention to reduce bottle use among toddlers: TARGet Kids! Pragmatic, randomized trial. Pediatrics. 2010 Aug;126(2):e343-50. doi: 10.1542/peds.2009-3583. Epub 2010 Jul 12.